A PHASE 1/2 STUDY OF ONCT-534 IN SUBJECTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Research type
Research Study
Full title
A PHASE 1/2 STUDY OF ONCT-534 IN SUBJECTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
IRAS ID
1008387
Contact name
Elisabeth Coates
Contact email
Sponsor organisation
Oncternal Therapeutics, Inc
Clinicaltrials.gov Identifier
Research summary
Study ONCT-534-101 is a Phase 1/2 study to evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of
ONCT-534 in subjects with metastatic castration-resistant prostate cancer (mCRPC) resistant to next-generation signaling inhibitors
(ARSIs) such as enzalutamide, darolutamide, apalutamide, or abiraterone.
The study will be separated into Phase 1 Dose Escalation and Phase 2 Dose Expansion portions.
In Phase 1, the safety and tolerability of ONCT-534 will be assessed to determine the maximum tolerated dose (MTD) to inform the
2 dose levels or schedules to be tested in Phase 2. In Phase 2, the safety and tolerability of two doses of ONCT-534 will be further
assessed in order to inform the optimal dose of ONCT-534. The antitumor activity, PK, and pharmacodynamics of ONCT534 will be
assessed in both portions of the study.
The sample size in the Phase 1 dose escalation portion will be approximately 27 subjects across 5 planned dose levels.
The Phase 2 dose expansion portion of the study will consist of 2 randomized cohorts, with approximately 16 patients per
expansion cohort (32 patients total).REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0028
Date of REC Opinion
19 Feb 2024
REC opinion
Further Information Favourable Opinion