KZR-261 in Subjects With Advanced Solid Malignancies
Megadott ok: Sponsor decision.
Key facts
- Where
- Atlanta, Cleveland, Detroit, Fairfax, Los Angeles, Nashville, Philadelphia, San Antonio, Seattle és Tampa, Egyesült ÁllamokSee the 12 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Winship Cancer Institute of Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
- Cleveland ClinicCleveland, Egyesült ÁllamokNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokNo longer taking part
- Henry Ford Health SystemDetroit, Egyesült ÁllamokNo longer taking part
- Virginia Cancer Specialists (VCS)Fairfax, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- University of California, Los AngelesLos Angeles, Egyesült ÁllamokNo longer taking part
- Sara Cannon Research Institution (SCRI) - Tennessee Oncology NashvilleNashville, Egyesült ÁllamokNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- START South Texas Accelerated Research TherapeuticsSan Antonio, Egyesült ÁllamokNo longer taking part
- Fred Hutchinson Cancer CenterSeattle, Egyesült ÁllamokNo longer taking part
- Moffitt Cancer CenterTampa, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Kezar Life Sciences, Inc.
- Trial code
- NCT05047536
- Record updated
- 2025. december 19.
- Original description
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").Read full original descriptionShow less
A Phase 1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, 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 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").
Inclusion: 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 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: 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; Uncontrolled, clinically significant pulmonary disease; Subjects who have participated in Part 1 dose escalation are not eligible to enroll in Part 2 dose expansion; 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).