A first-in-human clinical trial to test the investigational treatment ONCT-534 in participants with metastatic castration-resistant prostate cancer. The main questions it aims to answer are: * What are the most tolerable doses of ONCT-534? (Phase 1) * Does ONCT-534 have anti-tumor activity at tolerable doses? (Phase 2) This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534.
This is a Phase 1/2 multi-center study to investigate the safety, tolerability, and anti-tumor acitivity of ONCT-534 in patients with relapsed or refractory metastatic castration-resistant prostate cancer. The study consists of 2 phases: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. * During the dose escalation in Phase 1 a group of participants will be assigned a certain dose level. Once the dose level is considered safe, the next group will be assigned a higher dose level. The dose level may be raised or lowered depending on any safety events that occur throughout Phase 1. There will be approximately 27 participants enrolled in Phase 1. At the end of Phase 1, two dose levels will be chosen to be tested in Phase 2. * During Phase 2, participants will be randomly assigned to 1 of the 2 dose levels chose in Phase 1. Approximately 16 participants will be enrolled in each of the 2 dose level groups, for a total of 32 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
University of California San Francisco
San Francisco, California, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
XCancer Omaha
Omaha, Nebraska, United States
Dose Limiting Toxicities Through Study Day 28
Incidence of DLTs through Study Day 28
Time frame: Number of Participants with Dose Limiting Toxicities Through Study Day 28
Reduction of Prostate-Specific Antigen (PSA) by More Than 50%
Proportion of patients who achieve at least a 50% drop in PSA from baseline (PSA50)
Time frame: Up to 51 Weeks
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Columbia University Medical Center
New York, New York, United States
NEXT Oncology
Austin, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Next Virginia
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
The Royal Marsden NHS Trust
Sutton, Surrey, United Kingdom