Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1
61 participants
INTERVENTIONAL
2021-09-30
2025-01-17
Brief Summary
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Detailed Description
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* melanoma/uveal melanoma
* mesothelioma
* colorectal cancer
* castration-resistant prostate cancer
* "All-Tumors" (other advanced solid malignancies)
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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
Up to approximately 50 participants were to be enrolled and treated with KZR-261 in Part 1 (Dose Escalation). In Part 2A (Dose Expansion), up to 175 participants (15-35 per tumor cohort \[melanoma, uveal melanoma, colorectal cancer, castration-resistant prostate cancer, mesothelioma, and "All-Tumor"\]) were to be enrolled. In Part 2B (Dose Optimization), up to 120 participants from up to 4 tumor types from the Dose Expansion were to be enrolled.
TREATMENT
NONE
Study Groups
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KZR-261 with standard therapy: open-label
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.
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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.
KZR-261
KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.
Interventions
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KZR-261
KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 judgement 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, castration-resistant prostate cancer, mesothelioma).
Exclusion Criteria
* 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 the subject's first dose of KZR-261.
* Radiation therapy within 14 days of before administration of the subject's first dose of KZR-261.
* Major surgical procedure within 28 days before administration of the subject's first dose 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, or who are actively trying to conceive at the time of signing of the informed consent form (ICF).
* Uncontrolled, clinically significant pulmonary disease.
18 Years
ALL
No
Sponsors
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Kezar Life Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kezar Study Director
Role: STUDY_DIRECTOR
Kezar Life Sciences, Inc.
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Henry Ford Health System
Detroit, Michigan, United States
University Hospitals - Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sara Cannon Research Institution (SCRI) - Tennessee Oncology Nashville
Nashville, Tennessee, United States
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, United States
Virginia Cancer Specialists (VCS)
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Kezar Life Sciences, Inc. corporate website
Other Identifiers
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KZR-261-101
Identifier Type: -
Identifier Source: org_study_id