KZR-261 in Subjects With Advanced Solid Malignancies

Last updated: August 15, 2024
Sponsor: Kezar Life Sciences, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

KZR-261

Clinical Study ID

NCT05047536
KZR-261-101
  • Ages > 18
  • All Genders

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 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").

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that iseither metastatic or locally advanced and unresectable (and for which additionalradiation therapy or other locoregional therapies are not considered to result inreasonable clinical benefit).

  • Disease that is resistant to or relapsed following available standard systemictherapy, or for which there is no standard systemic therapy or reasonable therapy inthe Investigator's judgement likely to result in clinical benefit, or if suchtherapy has been refused by the subject. Documentation of the reason must beprovided for subjects who have not received a standard therapy likely to result inclinical 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

Exclusion Criteria:

  • Subjects who have participated in Part 1 dose escalation are not eligible to enrollin 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 14 days before administration of the subject's first dose of KZR-261.

  • Treatment with an investigational drug within 28 days before administration of thesubject's first dose of KZR-261.

  • Radiation therapy within 14 days of before administration of the subject's firstdose of KZR-261.

  • Major surgical procedure within 28 days before administration of the subject's firstdose of KZR-261.

  • History of risk factors for Torsades de pointes.

  • Active, symptomatic CNS metastases or primary CNS malignancy.

  • Any female who is breastfeeding or who plans to become pregnant during the study, orwho are actively trying to conceive at the time of signing of the informed consentform (ICF).

  • Uncontrolled, clinically significant pulmonary disease.

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: KZR-261
Phase: 1
Study Start date:
September 30, 2021
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals - Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Sara Cannon Research Institution (SCRI) - Tennessee Oncology Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • START (South Texas Accelerated Research Therapeutics)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Virginia Cancer Specialists (VCS)

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

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