KZR-261 in Subjects With Advanced Solid Malignancies

  • End date
    Oct 17, 2023
  • participants needed
  • sponsor
    Kezar Life Sciences, Inc.
Updated on 4 October 2022


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 comprises a Part 1 (Dose Escalation) and a Part 2 (Dose Expansion) in solid organ tumors (melanoma/uveal melanoma, mesothelioma, colorectal cancer, prostate cancer, and "all-tumors").


The first-in-human, open-label, multicenter, Phase 1 study of KZR-261, Study KZR-261-101, will be 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 subjects with locally advanced or metastatic solid malignancies for whom no therapeutics are available that can confer a reasonable likelihood of clinical benefit. The 5 tumor cohorts in the dose expansion part include advanced malignant:

  • melanoma/uveal melanoma
  • mesothelioma
  • colorectal cancer
  • castrate-resistant prostate cancer
  • "all-tumors"

Part 1 (Dose Escalation) and Part 2 (Dose Expansion) comprise 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.

Condition Advanced/Metastatic Solid Tumor
Treatment KZR-261
Clinical Study IdentifierNCT05047536
SponsorKezar Life Sciences, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered to result in reasonable clinical benefit)
Disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the Investigator's judgment likely to result in clinical benefit, or if such therapy has been refused by the subject. Documentation of the reason must be provided for subjects who have not received a standard therapy likely to result in clinical benefit
Eastern Cooperative Oncology Group Performance Status score of 0 or 1
Adequate baseline hematologic and organ function
Willing to use contraception
Additional Inclusion for Part 2: Histologic or cytologic evidence of malignancy
(melanoma/uveal melanoma, colorectal cancer, prostate cancer, mesothelioma)

Exclusion Criteria

Subjects who have participated in Part 1 dose escalation are not eligible to enroll in
Part 2 dose expansion
Persistent clinically significant toxicities from previous anticancer therapy
(excluding alopecia)
Treatment with cytotoxic, biologic, or targeted therapies for advanced cancer within
days before administration of the subject's first dose of KZR-261
Treatment with an investigational drug within 28 days before administration of the
subject's first dose of KZR-261
History of risk factors for Torsades de pointes
Radiation therapy within 14 days of before administration of the subject's first dose
Active, symptomatic CNS metastases or primary CNS malignancy
of KZR-261
Uncontrolled, clinically significant pulmonary disease
Major surgical procedure within 28 days before administration of the subject's first
dose of KZR-261
Any female who is breastfeeding or who plans to become pregnant during the study, or
who are actively trying to conceive at the time of signing of the informed consent
form (ICF)
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