A Phase 1/2 interventional study of Modakafusp Alfa and Pembrolizumab in Neoplasms and Melanoma, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Terminated at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC · Phase 1/2, Interventional, and Other
This study has 2 phases.
The main aims of Phase 1b are:
The main aims of Phase 2 are:
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity as single agent (SA) or in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will consist of 2 phases: Phase 1b dose escalation and a Phase 2 dose expansion.
The study will enroll approximately 114 participants (approximately 30 participants in Phase 1b dose escalation phase; 3-9 participants in safety-lead in and 25 participants for each expansion cohort (3 cohorts) of Phase 2.
The dose escalation phase will enroll participants with solid tumors. The dose escalation phase is to evaluate SA recommended phase 2 dose (RP2D).
The dose expansion phase in combination with pembrolizumab will be initiated with a safety lead-in phase once the SA RP2D is determined for modakafusp alfa. The dose expansion will include participants with one of following 3 disease indications:
I. Unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-disease programmed cell death protein 1 (PD1) containing treatments in the metastatic setting.
II. Unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic cutaneous melanoma naïve to prior anti-PD1 containing treatments in the metastatic setting.
This multi-center trial will be conducted in the United States and Australia. Participants with demonstrated clinical benefit may continue treatment beyond 1 year for Phase 1b and 2 years for Phase 2 if approved by the sponsor. The overall time to participate in this study is 55 months. All participants will make an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first for a safety follow up assessment.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase 2 Dose Expansion:
The combination cohorts, including participants in the safety-lead phase, will enroll participants with unresectable/metastatic melanoma in the following subgroups:
I. Unresectable/metastatic histologically confirmed cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
II. Unresectable/metastatic histologically confirmed cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic histologically confirmed cutaneous melanoma naive to prior anti-PD1 containing treatments in the metastatic setting.
Exclusion Criteria:
Modakafusp alfa 0.1 to 6 milligram per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle for up to 1 year.
Drug: Modakafusp Alfa
Melanoma with primary resistance to prior anti-PD1, acquired resistance to prior anti-PD1 or naïve to anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years. The starting dose of modakafusp alfa for dose expansion safety lead-in phase will be the RP2D determined in the previous Phase 1b dose escalation phase.
Drug: Modakafusp Alfa · Drug: Pembrolizumab
Melanoma With Primary Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety-lead in phase.
Drug: Modakafusp Alfa · Drug: Pembrolizumab
Melanoma With Acquired Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Drug: Modakafusp Alfa · Drug: Pembrolizumab
Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma naive to prior line of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Drug: Modakafusp Alfa · Drug: Pembrolizumab
Modakafusp alfa intravenous infusion.
Also known as: TAK-573
Pembrolizumab intravenous infusion.
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time frame: From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs
TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Time frame: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade \>=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade \>=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade \>=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting.
Time frame: Cycle 1 (Cycle length is equal to [=] 21 days)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs)
SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
Time frame: From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time frame: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From the first dose of study drug up to end of treatment or end of study (up to 2 years)
Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa
The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval.
Time frame: Cycle 1 (Cycle length = 21 days)
Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in
The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0.
Time frame: Cycle 1 (Cycle length = 21 days)
Phase 2 Expansion: Number of Participants Reporting One or More TEAEs
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time frame: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)
Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs
TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Time frame: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)
Phase 2 Expansion: Number of Participants Reporting One or More SAEs
SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
Time frame: From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 2 years 1 month)
Phase 2 Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time frame: From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month)
Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa
Cmax for modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa
Tmax for modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa
AUClast for modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa
AUCinf of modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa
T1/2z of modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa
CL was total clearance of the drug from the serum. CL of modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa
Vss of modakafusp alfa was reported.
Time frame: Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days)
Phase 1b and Phase 2 Safety Lead-in: ORR Based on RECIST v1.1
ORR was defined as the percentage of participants who achieved CR or PR as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)
Phase 1b and Phase 2: Disease Control Rate (DCR) Based on RECIST v1.1
DCR was defined as the percentage of participants who achieved CR, PR, or stable disease (SD) (determined by the investigator) as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD), taking as reference the smallest sum diameters while on study.
Time frame: From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)
Phase 1b and Phase 2: Duration of Response (DOR) Based on RECIST v1.1
DOR was defined as the time from the first documentation of a response (CR or PR) until PD or death, whichever occurred first as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time frame: From the date of first documentation of a CR or PR until PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])
Phase 1b and Phase 2: Time to Progression (TTP) Based on RECIST v1.1
TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time frame: From the date of the first dose of study drug to the date of the first documentation of PD (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])
Phase 1b and Phase 2: Progression Free Survival (PFS) Based on RECIST v1.1
PFS was defined as the time from the date of the first dose of study drug to the date of first documentation of PD according to RECIST v.1.1, or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time frame: From the date of the first dose of study drug to the date of first documentation of PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])
Phase 1b and Phase 2: Overall Survival (OS) Based on RECIST v1.1
OS was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Time frame: From the date of first dose of study drug to the date of death due to any cause (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2])
Phase 2 Expansion: ORR Based on Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR was defined as the percentage of participants whose BOR was immune CR (iCR) or immune PR (iPR), according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions immune confirmed progressive disease (iCPD). (iCPD): immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. iSD: immune stable disease in the absence of iCR or immune PD (iPD). iUPD: immune unconfirmed progressive disease (iUPD) when iCPD is unconfirmed NE: not evaluable.
Time frame: From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years])
Phase 2 Expansion: DCR Based on iRECIST
DCR was defined as percentage of participants who have achieved the best response of iCR, iPR, iSD based on iRECIST as per investigator assessment. iCR: achieved with disappearance of all target lesions, iPR: achieved with disappearance of partial target lesions. iSD: in the absence of iCR or iCPD. iUPD: when iPD is unconfirmed NE: not evaluable.
Time frame: From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years])
Phase 2 Expansion: DOR Based on iRECIST
DOR was defined as time from date of first observation of response (iPR or iCR) to date of the first observation of progression (iCPD) based on iRECIST as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From first documented confirmed iCR or iPR until first documentation of iCPD or death (up to end of treatment or end of study [up to 2 years])
Phase 2 Expansion: TTP Based on iRECIST
TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of iCPD based on iRECIST as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the date of the first dose of study drug to the date of the first documentation of iCPD (up to end of treatment or end of study [up to 2 years])
Phase 2 Expansion: PFS Based on iRECIST
PFS was defined as the time from the first dose date to the date of iCPD or date of death (whichever occurred first) based on iRECIST as per investigator assessment. iCPD was defined as immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From first dose of study drug until confirmed iCPD or death (up to end of treatment or end of study [up to 2 years])
Phase 1b and Phase 2: Number of Participants With Positive Anti-Modakafusp Alfa Antibodies (ADA) Status
ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive.
Time frame: Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)
Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies (ADA)
ADA titers were assessed by confirmatory assay.
Time frame: Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2)
Participants took part in the study at 17 investigative sites in the United States and Australia from 12 December 2019 to 20 December 2023.
| Milestone | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort III: Modakafusp Alfa + Pembrolizumab |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 6 | 3 | 9 | 12 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 3 | 3 | 3 | 3 | 6 | 3 | 9 | 12 | 0 |
| Withdrew: Death | 1 | 2 | 2 | 3 | 3 | 4 | 1 | 2 | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 7 | 7 | 0 |
Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 3 | 3 | 3 | 3 | 3 | 6 | 3 |
TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | 2 | 1 | 2 | 2 | 3 | 4 | 2 |
A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade \>=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade \>=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade \>=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs) | 3 | 1 | 2 | 1 | 2 | 4 | 0 |
TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| TEAEs Leading to Dose Modifications | 0 | 0 | 2 | 1 | 1 | 4 | 1 |
| TEAEs Leading to Treatment Discontinuations | 0 | 0 | 1 | 0 | 0 | 2 | 0 |
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1 | 0.0 (0.0 to 33.6) | 16.7 (2.1 to 48.4) |
The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval.
| milligrams per kilograms (mg/kg) | Phase 1b, Dose Escalation: All Participants |
|---|---|
| Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa | NA |
The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0.
| mg/kg | Phase 1b, Dose Escalation: All Participants | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in | 1.0 | 1.0 |
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
| Participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | 8 | 12 |
TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
| Participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | 6 | 7 |
SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
| Participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: Number of Participants Reporting One or More SAEs | 2 | 6 |
TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
| Participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| TEAEs Leading to Dose Modifications | 1 | 9 |
| TEAEs Leading to Treatment Discontinuations | 0 | 1 |
Cmax for modakafusp alfa was reported.
| nanograms per milliliter (ng/mL) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 261 ± 85.0 | 2770 ± 51.4 | 4920 ± 42.9 | 17000 ± 26.1 | 17700 ± 60.1 | 37200 ± 29.9 | 21200 ± 18.7 |
| Cycle 2 Day 1 | 336 ± 540.2 | 2790 ± 14.2 | 3560 ± 99.9 | 9420 ± 52.7 | 14400 ± 136.2 | 25400 ± 84.5 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 13900 ± NA |
Tmax for modakafusp alfa was reported.
| hour | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1.53 (1.48 to 1.72) | 1.17 (1.03 to 1.17) | 1.05 (0.98 to 1.20) | 1.18 (1.17 to 2.12) | 1.52 (1.12 to 2.02) | 1.97 (1.03 to 2.72) | 3.13 (2.60 to 3.42) |
| Cycle 2 Day 1 | 1.28 (1.05 to 1.50) | 1.03 (1.00 to 1.05) | 1.05 (0.92 to 3.92) | 1.07 (1.03 to 3.18) | 1.77 (1.60 to 1.93) | 1.97 (1.03 to 2.72) | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 2.90 (2.90 to 2.90) |
AUClast for modakafusp alfa was reported.
| hour*nanogram per milliliter (h*ng/mL) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 458 ± 135.8 | 8450 ± 70.0 | 33100 ± 72.4 | 183000 ± 74.1 | 262000 ± 61.5 | 897000 ± 57.1 | 455000 ± 21.8 |
| Cycle 2 Day 1 | 535 ± 1101.2 | 8030 ± 9.3 | 20300 ± 153.2 | 86300 ± 81.7 | 159000 ± 219.2 | 360000 ± 112.5 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 165000 ± NA |
AUCinf of modakafusp alfa was reported.
| h*ng/mL | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1470 ± NA | 8780 ± 66.3 | 33100 ± 72.2 | 217000 ± 60.2 | 263000 ± 61.5 | 1060000 ± 62.1 | 455000 ± 21.8 |
| Cycle 2 Day 1 | 2540 ± NA | 8840 ± 7.1 | 21100 ± 140.1 | 86400 ± 81.6 | 160000 ± 218.7 | 372000 ± 121.3 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 165000 ± NA |
T1/2z of modakafusp alfa was reported.
| hour | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1.07 ± NA | 1.97 ± 33.9 | 5.25 ± 13.7 | 5.60 ± 28.5 | 6.23 ± 14.4 | 15.5 ± 71.8 | 6.44 ± 11.0 |
| Cycle 2 Day 1 | 0.832 ± NA | 1.85 ± 9.1 | 3.08 ± 38.6 | 6.43 ± 11.3 | 6.15 ± 7.7 | 14.1 ± 85.6 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 6.15 ± NA |
CL was total clearance of the drug from the serum. CL of modakafusp alfa was reported.
| liters per hour per kilograms (L/h/kg) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 0.0682 ± NA | 0.0228 ± 66.2 | 0.0121 ± 72.4 | 0.00345 ± 61.0 | 0.00383 ± 61.1 | 0.00142 ± 61.1 | 0.00220 ± 21.3 |
| Cycle 2 Day 1 | 0.0394 ± NA | 0.0226 ± 7.2 | 0.0190 ± 139.6 | 0.00872 ± 81.1 | 0.00632 ± 214.5 | 0.00407 ± 118.5 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 0.00610 ± NA |
Vss of modakafusp alfa was reported.
| liters per kilograms (L/kg) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 0.119 ± NA | 0.0567 ± 49.7 | 0.0562 ± 58.2 | 0.0276 ± 13.5 | 0.0369 ± 48.1 | 0.0331 ± 33.1 | 0.0313 ± 13.3 |
| Cycle 2 Day 1 | 0.0546 ± NA | 0.0565 ± 15.6 | 0.0794 ± 135.8 | 0.0562 ± 72.9 | 0.0514 ± 107.2 | 0.0629 ± 33.4 | — |
| Cycle 3 Day 1 | — | — | — | — | — | — | 0.0453 ± NA |
ORR was defined as the percentage of participants who achieved CR or PR as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400mg |
|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: ORR Based on RECIST v1.1 | 0.0 (0.0 to 84.2) | 0.0 (0.0 to 84.2) | 0.0 (0.0 to 84.2) | 0.0 (0.0 to 70.8) | 0.0 (0.0 to 84.2) | 0.0 (0.0 to 60.2) | 0.0 (0.0 to 70.8) |
DCR was defined as the percentage of participants who achieved CR, PR, or stable disease (SD) (determined by the investigator) as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD), taking as reference the smallest sum diameters while on study.
| percentage of participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Disease Control Rate (DCR) Based on RECIST v1.1 | 0 (0.0 to 84.2) | 50.0 (1.3 to 98.7) | 0 (0.0 to 84.2) | 33.3 (0.8 to 90.6) | 0 (0.0 to 84.2) | 50.0 (6.8 to 93.2) | 33.3 (0.8 to 90.6) | 33.3 (7.5 to 70.1) | 41.7 (15.2 to 72.3) |
DOR was defined as the time from the first documentation of a response (CR or PR) until PD or death, whichever occurred first as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
| months | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Duration of Response (DOR) Based on RECIST v1.1 | — | — | — | — | — | — | — | — | NA (NA to NA) |
TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
| months | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Time to Progression (TTP) Based on RECIST v1.1 | 2.4 (1.41 to NA) | 4.5 (1.41 to NA) | 1.7 (0.79 to NA) | 1.4 (1.38 to NA) | 1.5 (NA to NA) | 2.3 (1.35 to NA) | 1.7 (1.31 to NA) | 2.8 (1.28 to 6.01) | 2.3 (1.35 to NA) |
PFS was defined as the time from the date of the first dose of study drug to the date of first documentation of PD according to RECIST v.1.1, or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
| months | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Progression Free Survival (PFS) Based on RECIST v1.1 | 2.4 (1.41 to NA) | 1.6 (1.41 to NA) | 1.7 (0.79 to NA) | 1.4 (1.38 to NA) | 1.8 (1.48 to NA) | 1.9 (0.95 to NA) | 1.7 (1.31 to NA) | 4.8 (1.31 to NA) | 2.6 (1.38 to NA) |
OS was defined as the time from the date of first dose of study drug to the date of death due to any cause.
| months | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Overall Survival (OS) Based on RECIST v1.1 | NA (3.61 to NA) | 9.8 (1.64 to NA) | 7.0 (0.99 to NA) | 6.3 (2.99 to NA) | 4.3 (1.84 to NA) | 3.1 (0.95 to NA) | NA (5.13 to NA) | NA (5.62 to NA) | NA (2.60 to NA) |
ORR was defined as the percentage of participants whose BOR was immune CR (iCR) or immune PR (iPR), according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions immune confirmed progressive disease (iCPD). (iCPD): immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. iSD: immune stable disease in the absence of iCR or immune PD (iPD). iUPD: immune unconfirmed progressive disease (iUPD) when iCPD is unconfirmed NE: not evaluable.
| percentage of participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: ORR Based on Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) | 0.0 (0.0 to 36.9) | 16.7 (2.1 to 48.4) |
DCR was defined as percentage of participants who have achieved the best response of iCR, iPR, iSD based on iRECIST as per investigator assessment. iCR: achieved with disappearance of all target lesions, iPR: achieved with disappearance of partial target lesions. iSD: in the absence of iCR or iCPD. iUPD: when iPD is unconfirmed NE: not evaluable.
| percentage of participants | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: DCR Based on iRECIST | 37.5 (8.5 to 75.5) | 41.7 (15.2 to 72.3) |
DOR was defined as time from date of first observation of response (iPR or iCR) to date of the first observation of progression (iCPD) based on iRECIST as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: DOR Based on iRECIST | — | NA (NA to NA) |
TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of iCPD based on iRECIST as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: TTP Based on iRECIST | 4.8 (1.31 to NA) | NA (1.38 to NA) |
PFS was defined as the time from the first dose date to the date of iCPD or date of death (whichever occurred first) based on iRECIST as per investigator assessment. iCPD was defined as immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|
| Phase 2 Expansion: PFS Based on iRECIST | 4.8 (1.31 to NA) | 2.6 (2.6 to NA) |
ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive.
| Participants | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Number of Participants With Positive Anti-Modakafusp Alfa Antibodies (ADA) Status | 2 | 2 | 3 | 3 | 3 | 4 | 3 | 9 | 10 |
ADA titers were assessed by confirmatory assay.
| titers | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies (ADA) | 150.0 (75 to 225) | 164000.0 (2020 to 1480000) | 6070.0 (675 to 492000) | 6070.0 (75 to 164000) | 6070.0 (2020 to 54700) | 109350.0 (2020 to 492000) | 273350.0 (225 to 1480000) | 492000.0 (225 to 4430000) | 164000.0 (225 to 1480000) |
Collected over From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 2/3 (66.7%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | 4/6 (66.7%) | 4/6 (66.7%) | 6/6 (100%) |
| Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | 1/3 (33.3%) | 0/3 (0%) | 3/3 (100%) |
| Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | 2/9 (22.2%) | 2/9 (22.2%) | 8/9 (88.9%) |
| Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab | 4/12 (33.3%) | 6/12 (50%) | 12/12 (100%) |
| Event | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab |
|---|---|---|---|---|---|---|---|---|---|
| Infusion related reactionInjury, poisoning and procedural complications | 3/3 | 0/3 | 1/3 | 1/3 | 0/3 | 2/6 | 0/3 | 1/9 | 2/12 |
| Acute kidney injuryRenal and urinary disorders | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| DysarthriaNervous system disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Failure to thriveMetabolism and nutrition disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| NauseaGastrointestinal disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 1/12 |
| Peripheral motor neuropathyNervous system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Peripheral sensory neuropathyNervous system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Event | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab |
|---|---|---|---|---|---|---|---|---|---|
| ChillsGeneral disorders | 3/3 | 0/3 | 1/3 | 1/3 | 2/3 | 3/6 | 0/3 | 3/9 | 5/12 |
| HeadacheNervous system disorders | 0/3 | 1/3 | 1/3 | 2/3 | 0/3 | 1/6 | 2/3 | 4/9 | 9/12 |
| AnaemiaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/3 | 1/6 | 2/3 | 2/9 | 1/12 |
| Back painMusculoskeletal and connective tissue disorders | 0/3 | 0/3 | 0/3 | 2/3 | 0/3 | 1/6 | 0/3 | 0/9 | 3/12 |
| Blood creatinine increasedInvestigations | 0/3 | 0/3 | 1/3 | 0/3 | 2/3 | 0/6 | 0/3 | 0/9 | 1/12 |
| Decreased appetiteMetabolism and nutrition disorders | 0/3 | 0/3 | 2/3 | 1/3 | 0/3 | 0/6 | 0/3 | 0/9 | 1/12 |
| FatigueGeneral disorders | 0/3 | 1/3 | 0/3 | 1/3 | 0/3 | 2/6 | 2/3 | 4/9 | 7/12 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/3 | 0/3 | 1/3 | 0/3 | 1/3 | 0/6 | 0/3 | 0/9 | 0/12 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/3 | 0/3 | 0/3 | 0/3 | 2/3 | 2/6 | 0/3 | 1/9 | 6/12 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/3 | 0/3 | 2/3 | 0/3 | 0/3 | 0/6 | 0/3 | 0/9 | 0/12 |
The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.
| Age, Continuous(years) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 74.0 ± 5.20 | 51.3 ± 11.37 | 68.0 ± 10.44 | 62.0 ± 8.19 | 55.0 ± 4.58 | 61.8 ± 9.13 | 74.3 ± 4.04 | 53.4 ± 17.91 | 60.3 ± 12.11 | 60.7 ± 13 |
| Sex: Female, Male(Participants) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 0 | 1 | 2 | 4 | 2 | 4 | 1 | 16 |
| Male | 2 | 2 | 3 | 2 | 1 | 2 | 1 | 5 | 11 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 2 | 7 |
| Not Hispanic or Latino | 3 | 2 | 2 | 2 | 1 | 5 | 2 | 8 | 8 | 33 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| White | 3 | 3 | 2 | 3 | 2 | 5 | 3 | 8 | 9 | 38 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 5 |
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