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NCT05047536 · ClinicalTrials.gov registry record · Phase 1
KZR-261 in Subjects With Advanced Solid Malignancies
A Phase 1 study, sponsored by Kezar Life Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT05047536: Clinical Trial Phase 1 study, sponsored by Kezar Life Sciences.
NCT05047536 is a Phase 1 study that was terminated before completion, run by Kezar Life Sciences. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05047536, a Phase 1 study, was terminated before completion, sponsored by Kezar Life Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
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").
Primary Outcome
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
Interventions
- DRUG KZR-261
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 1 |
Why NCT05047536 stopped before completion
NCT05047536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which KZR-261 is the first listed.
NCT05047536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05047536 about?
NCT05047536 is a clinical study titled "KZR-261 in Subjects With Advanced Solid Malignancies". 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 Par...
What is the current status of trial NCT05047536?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2021-09-30. Estimated completion is 2025-01-17.
What interventions are being tested in trial NCT05047536?
The interventions under investigation include: KZR-261 (DRUG).
Who is sponsoring clinical trial NCT05047536?
This trial is sponsored by Kezar Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05047536's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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