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KZR-261 in Subjects With Advanced Solid Malignancies

NCT05047536 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-12-19

Study results available
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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").

Conditions

  • Advanced/Metastatic Solid Tumor

Interventions

DRUG

KZR-261

KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.

Sponsors & Collaborators

  • Kezar Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kezar Study Director · Kezar Life Sciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2025-01-17
Completion
2025-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047536 on ClinicalTrials.gov