A Phase 1 interventional study of MSB0011359C in Solid Tumors, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 18 sites in 3 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment
The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.
Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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Other protocol-defined exclusion criteria could apply.
Exclusion Criteria:
Drug: MSB0011359C
Subjects with metastatic or locally advanced solid tumors received intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Also known as: M7824
Number of Participants With Dose Limiting Toxicity (DLT)
A DLT was defined as any grade greater than or equal to (\>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
Time frame: Baseline up to Week 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Time frame: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.
Time frame: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824
Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824
t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation.
Time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Time frame: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824
The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported.
Time frame: Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Time frame: Date of randomization up to 2 years
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Time frame: Date of randomization up to 2 years
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC)
The BOR per Independent Endpoint Review Committee (IRC) adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Time frame: Up to 2 years
Expansion Part: Duration of Response (DOR)
Duration of response according to RECIST 1.1 as adjudicated by the IRC was defined as the time from first confirmed response until the first documented disease progression that was subsequently confirmed. It was analyzed using Kaplan-Meier method.
Time frame: Up to 2 years
Expansion Part: Disease Control Rate
The disease control rate was defined as the percentage of participants with BOR. The BOR per IRC adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Time frame: Up to 2 years
Expansion Part: Progression Free Survival (PFS) Time
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time frame: Date of randomization until death or progressive disease assessed up to 2 years
Expansion Part: Overall Survival (OS) Time
OS was defined as the time from randomization to death due to any cause.
Time frame: Date of randomization until death assessed up to 2 years
| Milestone | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 7 | 30 | 31 | 30 | 3 | 6 |
| Completed | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Not completed | 4 | 3 | 7 | 30 | 31 | 29 | 3 | 6 |
| Withdrew: Death | 3 | 3 | 3 | 23 | 22 | 23 | 3 | 5 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 | 1 | 5 | 3 | 0 | 1 |
| Withdrew: Other | 1 | 0 | 1 | 6 | 4 | 3 | 0 | 0 |
A DLT was defined as any grade greater than or equal to (\>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
| Participants | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | 0 | 0 | 1 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
| Participants | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | 4 | 3 | 6 | 28 | 30 | 30 | 2 | 6 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.
| Participants | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03 | 1 | 2 | 3 | 19 | 16 | 19 | 0 | 0 |
Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
| Micrograms per milliliter (mcg/mL) | Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg]) | Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg]) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824 | 54.6 ± 17.9 | 211 ± 21.7 | 331 ± 19.2 |
t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
| hours | Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg]) | Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg]) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824 | 132 ± 12.8 | 138 ± 17.4 | 150 ± 24.4 |
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation.
| hour*microgram per milliliter(hr*mcg/mL) | Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg]) | Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg]) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824 | 7940 ± 16.7 | 29200 ± 25.3 | 51300 ± 24.7 |
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
| hr*mcg/mL | Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg]) | Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg]) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 | 9600 ± 15.2 | 34600 ± 29.7 | 61700 ± 26.6 |
The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported.
| Participants | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824 | 1 | 0 | 3 |
BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
| Participants | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) |
|---|---|---|---|
| Complete response | 0 | 0 | 0 |
| Partial response | 1 | 0 | 1 |
| Stable disease | 2 | 1 | 0 |
| Progressive disease | 1 | 2 | 4 |
| Not evaluable | 0 | 0 | 2 |
BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
| Participants | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer |
|---|---|---|---|
| Complete response | 1 | 2 | 0 |
| Partial response | 6 | 5 | 6 |
| Stable disease | 4 | 5 | 5 |
| Progressive disease | 17 | 16 | 17 |
| Not evaluable | 2 | 3 | 2 |
The BOR per Independent Endpoint Review Committee (IRC) adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
| Participants | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|
| Complete response (CR) | 2 | 3 | 0 | 0 | 0 |
| Partial Response (PR) | 4 | 3 | 3 | 0 | 0 |
| Stable disease (SD) | 6 | 2 | 3 | 1 | 0 |
| Non-CR/Non-PD | 0 | 0 | 3 | 0 | 0 |
| Progressive disease (PD) | 16 | 21 | 18 | 1 | 6 |
| Not evaluable (NE) | 2 | 2 | 3 | 1 | 0 |
Duration of response according to RECIST 1.1 as adjudicated by the IRC was defined as the time from first confirmed response until the first documented disease progression that was subsequently confirmed. It was analyzed using Kaplan-Meier method.
| Months | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer |
|---|---|---|---|
| Expansion Part: Duration of Response (DOR) | NA (8.3 to 34.5) | 20.8 (2.4 to 29.0) | 7.0 (2.8 to 24.9) |
The disease control rate was defined as the percentage of participants with BOR. The BOR per IRC adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
| Percentage of Participants | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) |
|---|---|---|---|---|---|
| Expansion Part: Disease Control Rate | 40.0 (22.7 to 59.4) | 22.6 (11.9 to 44.6) | 20 (14.7 to 49.4) | 1 (0.8 to 90.6) | 0 (0.0 to 45.9) |
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
| Months | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) |
|---|---|---|---|---|---|
| Expansion Part: Progression Free Survival (PFS) Time | 2.5 (0.0 to 38.6) | 1.3 (0.4 to 31.6) | 1.4 (0.0 to 30.3) | 2.1 (1.3 to 2.8) | 1.2 (0.8 to 2.7) |
OS was defined as the time from randomization to death due to any cause.
| Months | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|
| Expansion Part: Overall Survival (OS) Time | 12.7 (1.9 to 38.7) | 10.1 (0.5 to 38.3) | 11.9 (0.1 to 38.0) | 4.4 (4.3 to 6.9) | 4.0 (2.1 to NA) |
Collected over First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Expansion Cohort: Biliary Tract Cancer | 23/30 (76.7%) | 18/30 (60%) | 28/30 (93.3%) |
| Expansion Cohort: Gastric Cancer (GC) | 22/31 (71%) | 18/31 (58.1%) | 30/31 (96.8%) |
| Expansion Cohort: Esophageal Squamous Cell Cancer | 24/30 (80%) | 14/30 (46.7%) | 30/30 (100%) |
| Dose Escalation Cohort: M7824 (3 mg/kg) | 3/4 (75%) | 4/4 (100%) | 4/4 (100%) |
| Dose Escalation Cohort: M7824 (10 mg/kg) | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Dose Escalation Cohort: M7824 (20 mg/kg) | 3/7 (42.9%) | 5/7 (71.4%) | 6/7 (85.7%) |
| Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | 3/3 (100%) | 2/3 (66.7%) | 1/3 (33.3%) |
| Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | 5/6 (83.3%) | 3/6 (50%) | 6/6 (100%) |
| Event | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 1/30 | 1/31 | 1/30 | 3/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/30 | 3/31 | 1/30 | 0/4 | 0/3 | 0/7 | 1/3 | 0/6 |
| Paraneoplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 0/31 | 0/30 | 0/4 | 0/3 | 0/7 | 1/3 | 0/6 |
| HypopituitarismEndocrine disorders | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| DiarrhoeaGastrointestinal disorders | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| NauseaGastrointestinal disorders | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| VomitingGastrointestinal disorders | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| HyponatraemiaMetabolism and nutrition disorders | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| Malignant ascitesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 0/31 | 0/30 | 1/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| Event | Expansion Cohort: Biliary Tract Cancer | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) |
|---|---|---|---|---|---|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 7/30 | 7/31 | 4/30 | 4/4 | 1/3 | 1/7 | 0/3 | 1/6 |
| AnaemiaBlood and lymphatic system disorders | 10/30 | 11/31 | 7/30 | 3/4 | 0/3 | 2/7 | 0/3 | 1/6 |
| ConstipationGastrointestinal disorders | 4/30 | 7/31 | 5/30 | 2/4 | 0/3 | 1/7 | 0/3 | 0/6 |
| NauseaGastrointestinal disorders | 4/30 | 5/31 | 4/30 | 2/4 | 0/3 | 1/7 | 0/3 | 1/6 |
| VomitingGastrointestinal disorders | 3/30 | 3/31 | 2/30 | 2/4 | 0/3 | 1/7 | 0/3 | 0/6 |
| FatigueGeneral disorders | 5/30 | 6/31 | 3/30 | 2/4 | 0/3 | 1/7 | 0/3 | 0/6 |
| OedemaGeneral disorders | 1/30 | 0/31 | 0/30 | 2/4 | 0/3 | 1/7 | 0/3 | 0/6 |
| PyrexiaGeneral disorders | 13/30 | 7/31 | 5/30 | 2/4 | 0/3 | 3/7 | 0/3 | 1/6 |
| Aspartate aminotransferase increasedInvestigations | 2/30 | 1/31 | 3/30 | 2/4 | 1/3 | 1/7 | 0/3 | 0/6 |
| Blood creatinine increasedInvestigations | 0/30 | 1/31 | 2/30 | 2/4 | 0/3 | 0/7 | 0/3 | 0/6 |
| Age, Continuous(Years) | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 51 ± 8.7 | 57 ± 18.5 | 63 ± 9.3 | 54 ± 10.9 | 62 ± 11.5 | 60 ± 9.9 | 58 ± 16.5 | 56 ± 13.2 | 61 ± 11.1 |
| Sex: Female, Male(Participants) | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 11 | 5 | 5 | 4 | 1 | 1 | 32 |
| Male | 2 | 0 | 19 | 2 | 26 | 26 | 2 | 5 | 82 |
| Race/Ethnicity, Customized(Participants) | Dose Escalation Cohort: M7824 (3 mg/kg) | Dose Escalation Cohort: M7824 (10 mg/kg) | Expansion Cohort: Biliary Tract Cancer | Dose Escalation Cohort: M7824 (20 mg/kg) | Expansion Cohort: Gastric Cancer (GC) | Expansion Cohort: Esophageal Squamous Cell Cancer | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ethnicity-Japanese | 4 | 3 | 12 | 7 | 12 | 17 | 3 | 6 | 64 |
| Ethnicity-Korean | 0 | 0 | 15 | 0 | 14 | 3 | 0 | 0 | 32 |
| Ethnicity-Taiwanese | 0 | 0 | 3 | 0 | 5 | 10 | 0 | 0 | 18 |
| Race-Asian | 4 | 3 | 30 | 7 | 31 | 30 | 3 | 6 | 114 |
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Studies of the drug tested here: Bintrafusp alfa
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