Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Bartosz Chmielowski, MD, PhD (ucla)

Description

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").

Official Title

A Phase 1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects With Advanced Solid Malignancies

Details

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:

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.

Keywords

Advanced/Metastatic Solid Tumor, melanoma, uveal melanoma, colorectal cancer, prostate cancer, mesothelioma, Neoplasms, KZR-261

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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, prostate cancer, mesothelioma).

You CAN'T join if...

  • 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 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.

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kezar Life Sciences, Inc.
Links
Kezar Life Sciences, Inc. corporate website
ID
NCT05047536
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated