A Phase 1 interventional study of KZR-261 in Advanced/Metastatic Solid Tumor, sponsored by Kezar Life Sciences, Inc.. Terminated at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Kezar Life Sciences, Inc. · Phase 1, Interventional, and Treatment
A first-in-human, open-label, multicenter, Phase 1 study of KZR-261 designed to assess the safety and tolerability, preliminary anti-tumor activity, and pharmacokinetics (PK) of KZR-261, as well as identify the recommended Phase 2 dose (RP2D). The study comprised a Part 1 (Dose Escalation) and a Part 2 (2A Dose Expansion and 2B Dose Optimization) in solid organ tumors (melanoma/uveal melanoma, mesothelioma, colorectal cancer, castration-resistant prostate cancer, and "All-Tumors").
The first-in-human, open-label, multicenter, Phase 1 study of KZR-261, Study KZR-261-101, was conducted in two parts (dose escalation and dose expansion) to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of KZR-261 in participants with locally advanced or metastatic solid malignancies for whom no therapeutics are available (or available therapeutics were refused) that can confer a reasonable likelihood of clinical benefit. The 5 tumor cohorts in the dose expansion part include advanced malignant:
Part 1 (Dose Escalation) and Part 2 (2A Dose Expansion and 2B Dose Optimization) comprised a 4-week Screening Period, a Treatment Period lasting approximately 24 weeks, 4-6-week Safety Follow-up, and a 12-month Long-Term Follow-up Period (after last dose of study treatment), for a total study duration of approximately 20 months.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Kezar Life Sciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion for Part 2: Histologic or cytologic evidence of (melanoma/uveal melanoma, colorectal cancer, castration-resistant prostate cancer, mesothelioma).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1 (Dose Escalation): The initial dose cohort of the Dose Escalation received 1.8 mg/m2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to 6 cycles. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Part 2A (Dose Expansion): Following safety review of all Dose Escalation cohorts and determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD), KZR-261 was to be evaluated for safety and preliminary efficacy in 4 tumor-specific cohorts and 1 all-tumor cohort to determine the recommended phase 2 dose (RP2D). The 4 tumor-specific cohorts will include: * melanoma (including uveal melanoma) * colorectal cancer * castration-resistant prostate cancer * mesothelioma Part 2B (Dose Optimization): Dose optimization in tumor-specific cohorts could have been initiated based on the totality of data after the MTD/MAD had been determined. Participants were to receive KZR-261 at the MTD/MAD or a lower clinically active dose of KZR-261.
Drug: KZR-261
KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.
Also known as: KZR-261 for Injection
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
Time frame: 20 months
Number and Percentage of Participants Experiencing Dose-limiting Toxicities
Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).
Time frame: 28 days
Maximum Plasma Concentration of KZR-261 (Part 1)
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.
Time frame: Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15
The Plasma Concentration Time Curve of KZR-261 (Part 1)
This is the area under the curve (AUC) from predose through postdose observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, and 24 hours post infusion.
Time frame: Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15
Objective Response (ORR) Following KZR-261
The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.
Time frame: 20 months
Participants With Clinical Benefit of Stable Disease Following KZR-261
The clinical benefit rate defined as the number of participants achieving a best response of complete response (CR)/partial response (PR) or stable disease over at least 2 consecutive response assessment time points. Stable disease is defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of longest diameters of target lesions while on study.
Time frame: 20 months
Progression-free Survival of Participants Treated With KZR-261
The number of participants with progression-free survival (PFS), defined as the date of initiation of study treatment to the date of documented PD or death from any cause, whichever occurs first, at 4 months and 6 months. PFS is based on the number of subjects in each group in the response evaluable population at the specific timepoints (4 or 6 months).
Time frame: 4 months and 6 months
Overall Survival of Participants Treated With KZR-261
Time of overall survival for participants treated with KZR-261.
Time frame: 20 months
At the time of study termination, Part 2A of the study had only enrolled participants with melanomas. Part 2B of the study (Dose Optimization) did not occur.
| Milestone | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 6 | 6 | 6 | 5 | 17 | 8 | 7 |
| Completed | 1 | 0 | 1 | 0 | 1 | 3 | 1 | 0 | 0 | 0 |
| Not completed | 1 | 2 | 1 | 6 | 5 | 3 | 4 | 17 | 8 | 7 |
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
| participants | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Mild (Grade 1) | 2 | 2 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
| Moderate (Grade 2) | 0 | 0 | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 2 |
| Severe (Grade 3) | 0 | 0 | 0 | 3 | 4 | 4 | 1 | 5 | 2 | 0 |
| Life-threatening (Grade 4) | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 12 | 5 | 5 |
| Death (Grade 5) | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).
| Participants | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 |
|---|---|---|---|---|---|---|---|---|---|
| Number and Percentage of Participants Experiencing Dose-limiting Toxicities | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.
| ng/mL | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 |
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1, Day 1 | 601.5 ± 26.9 | 1414.9 ± 1.5 | 1536.1 ± 34.7 | 2793.5 ± 44.9 | 5126.6 ± 37.8 | 7475.8 ± 10.9 | 9531.2 ± 39.5 | 12159.8 ± 27.8 | 16346.5 ± 27.4 |
| Cycle 1, Day 15 | 580.6 ± 35.5 | 2160.0 ± NA | 2413.2 ± 46.0 | 4149.8 ± 45.6 | 4409.6 ± 40.2 | 7571.7 ± 23.8 | 11906.8 ± 23.6 | 12917.1 ± 36.0 | 25955.5 ± 154.2 |
| Cycle 2, Day 1 | 566.5 ± 13.3 | 1724.4 ± 46.7 | 2406.6 ± 57.4 | 3712.8 ± 54.5 | 4359.1 ± 18.7 | 6686.2 ± 21.1 | 14497.6 ± 42.2 | 12208.5 ± 36.0 | 31491.0 ± 260.2 |
| Cycle 2, Day 15 | 603.2 ± 20.7 | 1334.6 ± 61.3 | 2128.8 ± 36.3 | 3510.7 ± 27.5 | 4409.6 ± 28.6 | 7343.5 ± 24.9 | 12218.5 ± 11.0 | 15342.7 ± 31.4 | 18300.0 ± NA |
This is the area under the curve (AUC) from predose through postdose observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, and 24 hours post infusion.
| hr*ng/mL | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 |
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1, Day 1 | 653.2 ± 14.5 | 1483.4 ± 101.6 | 2252.7 ± 13.7 | 5592.0 ± 74.6 | 6427.1 ± 30.8 | 9919.2 ± 11.1 | 15766.7 ± 15.3 | 22918.9 ± 45.4 | 34948.3 ± 31.7 |
| Cycle 1, Day 15 | 528.6 ± 20.5 | 2596.4 ± NA | 2511.2 ± 42.4 | 4259.1 ± 26.4 | 6280.1 ± 31.8 | 8944.0 ± 16.4 | 14624.8 ± 13.9 | 18088.1 ± 27.0 | 38084.6 ± 96.2 |
| Cycle 2, Day 1 | 532.2 ± 2.9 | 1506.8 ± 68.2 | 2485.0 ± 12.1 | 6536.5 ± 80.4 | 7030.0 ± 21.6 | 10171.0 ± 18.0 | 20581.5 ± 36.2 | 20847.3 ± 57.6 | 48172.7 ± 92.3 |
| Cycle 2, Day 15 | 568.6 ± 21.8 | 1304.5 ± 78.3 | 2126.4 ± 22.7 | 5135.9 ± 53.6 | 6246.6 ± 28.2 | 8958.0 ± 23.2 | 17093.8 ± 16.0 | 22390.0 ± 31.7 | 37991.6 ± NA |
The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.
| participants | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Objective Response (ORR) Following KZR-261 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The clinical benefit rate defined as the number of participants achieving a best response of complete response (CR)/partial response (PR) or stable disease over at least 2 consecutive response assessment time points. Stable disease is defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of longest diameters of target lesions while on study.
| Participants | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Participants With Clinical Benefit of Stable Disease Following KZR-261 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 2 | 0 | 1 |
The number of participants with progression-free survival (PFS), defined as the date of initiation of study treatment to the date of documented PD or death from any cause, whichever occurs first, at 4 months and 6 months. PFS is based on the number of subjects in each group in the response evaluable population at the specific timepoints (4 or 6 months).
| Participants | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| 4 Months | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 2 | 0 | 1 |
| 6 Months | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 |
Time of overall survival for participants treated with KZR-261.
| weeks | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Survival of Participants Treated With KZR-261 | 21.7 (21.0 to NA) | 22.6 (12.6 to NA) | NA (15.0 to NA) | 17.9 (8.4 to NA) | NA (39.7 to NA) | NA (33.9 to NA) | 53.4 (11.7 to NA) | 12.4 (7.9 to 26.1) | NA (9.3 to NA) | 24.6 (19.4 to NA) |
Collected over Through end of study, up to 2.25 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Dose 2 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Dose 3 | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Dose 4 | 1/6 (16.7%) | 3/6 (50%) | 6/6 (100%) |
| Dose 5 | 1/6 (16.7%) | 3/6 (50%) | 6/6 (100%) |
| Dose 6 | 0/6 (0%) | 3/6 (50%) | 6/6 (100%) |
| Dose 7 | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Dose 8 | 0/17 (0%) | 8/17 (47.1%) | 17/17 (100%) |
| Dose 9 | 0/8 (0%) | 4/8 (50%) | 7/8 (87.5%) |
| Melanoma Expansion Cohort | 0/7 (0%) | 4/7 (57.1%) | 7/7 (100%) |
| Event | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 1/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| Abdominal pain upperGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/6 | 1/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| AscitesGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/6 | 1/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| HaematemesisGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 0/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| NauseaGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 0/6 | 1/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 0/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| VomitingGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 0/6 | 1/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| FatigueGeneral disorders and administration site conditions | 0/2 | 0/2 | 0/2 | 0/6 | 0/6 | 1/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| Non-cardiac chest painGeneral disorders and administration site conditions | 0/2 | 0/2 | 0/2 | 0/6 | 0/6 | 1/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/2 | 0/2 | 0/2 | 0/6 | 1/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| Event | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort |
|---|---|---|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders and administration site conditions | 0/2 | 0/2 | 0/2 | 1/6 | 4/6 | 1/6 | 0/5 | 5/17 | 3/8 | 1/7 |
| Neutrophil count decreasedInvestigations | 0/2 | 0/2 | 0/2 | 0/6 | 1/6 | 1/6 | 2/5 | 10/17 | 3/8 | 3/7 |
| NauseaGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 1/6 | 2/6 | 3/6 | 2/5 | 5/17 | 1/8 | 4/7 |
| VomitingGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 1/6 | 1/6 | 3/6 | 2/5 | 6/17 | 2/8 | 4/7 |
| DiarrhoeaGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/6 | 3/6 | 0/6 | 0/5 | 3/17 | 1/8 | 1/7 |
| Epigastric discomfortGastrointestinal disorders | 0/2 | 1/2 | 0/2 | 0/6 | 0/6 | 0/6 | 0/5 | 0/17 | 0/8 | 1/7 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 0/6 | 3/6 | 0/6 | 0/5 | 2/17 | 0/8 | 0/7 |
| Oedema peripheralGeneral disorders and administration site conditions | 0/2 | 0/2 | 0/2 | 0/6 | 3/6 | 0/6 | 0/5 | 0/17 | 0/8 | 0/7 |
| PyrexiaGeneral disorders and administration site conditions | 0/2 | 0/2 | 0/2 | 0/6 | 3/6 | 0/6 | 0/5 | 4/17 | 1/8 | 0/7 |
| Back painMusculoskeletal and connective tissue disorders | 0/2 | 0/2 | 1/2 | 0/6 | 1/6 | 0/6 | 0/5 | 0/17 | 2/8 | 0/7 |
| Age, Continuous(years) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 69.4 ± 8.5 | 61.1 ± 3.6 | 81.4 ± 9.6 | 59.8 ± 13.2 | 67.2 ± 5.0 | 67.3 ± 6.4 | 64.4 ± 7.0 | 67.4 ± 8.8 | 59.0 ± 12.5 | 71.3 ± 10.5 | 66.0 ± 10.0 |
| Sex: Female, Male(Participants) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 4 | 3 | 5 | 5 | 8 | 5 | 4 | 34 |
| Male | 2 | 2 | 2 | 2 | 3 | 1 | 0 | 9 | 3 | 3 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 1 | 0 | 8 |
| Not Hispanic or Latino | 0 | 1 | 2 | 5 | 5 | 5 | 5 | 15 | 7 | 7 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 5 |
| White | 2 | 1 | 2 | 4 | 5 | 4 | 5 | 14 | 6 | 7 | 50 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 |
| ECOG Performance Status at Screening(Participants) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Zero | 1 | 0 | 1 | 0 | 1 | 2 | 4 | 3 | 3 | 4 | 19 |
| One | 1 | 2 | 1 | 6 | 5 | 4 | 1 | 14 | 5 | 3 | 42 |
| Two | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Three | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Four | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Done | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Type of Cancer Under Study(Participants) | Dose 1 | Dose 2 | Dose 3 | Dose 4 | Dose 5 | Dose 6 | Dose 7 | Dose 8 | Dose 9 | Melanoma Expansion Cohort | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Breast | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Cervical | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Colorectal | 1 | 1 | 0 | 3 | 4 | 2 | 1 | 1 | 2 | 0 | 15 |
| Esophagus | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Gastric | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 4 |
| Head and Neck | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Lung | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 2 | 1 | 0 | 6 |
| Malignant Cutaneous Melanoma | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 5 | 7 |
| Malignant Uveal Melanoma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 3 |
| Mesothelioma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Ovarian | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Pancreatic | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 6 | 0 | 0 | 8 |
| Prostate | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Other | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 4 | 1 | 0 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2021 to primary completion in Jan 2025, 39 months.
Results were first posted in Dec 2025, 11 months after primary completion.
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Kezar Life Sciences, Inc.