Oncternal: Enrollment complete in 1/2 Study of ONCT-534 to treat R/R PCa

Oncternal Therapeutics announced that enrollment has been completed and dosing initiated for the fifth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors ARPI. Patients in the fifth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor DAARI , at a dose of 600 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee SRC after reviewing data from the fourth dose level of 300 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate-specific antigen PSA levels from this study is expected in the third quarter of 2024 and will include data from this 600 mg dose cohort. “We are encouraged by the rapid enrollment in the dose escalation portion of our Phase 1/2 study with ONCT-534. The drug has been well tolerated, with no dose limiting toxicities observed to date. We continue to open new sites and patient demand continues to be strong,” said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. “We are looking forward to sharing initial safety and efficacy data soon, which will include a larger, more robust set of clinical and biomarker results, as well as longer follow-up from the initial dosing cohorts.”