Core Insights - Oncternal Therapeutics has completed enrollment and initiated dosing for the fifth dose cohort of its Phase 1/2 study of ONCT-534, targeting metastatic castration-resistant prostate cancer (mCRPC) patients who are relapsed or refractory to approved androgen receptor pathway inhibitors [1][2] - The fifth cohort is receiving ONCT-534 at a dose of 600 mg daily, following a review by the Safety Review Committee which found the previous 300 mg dose to be well tolerated [1][2] - Initial safety and efficacy data based on prostate-specific antigen (PSA) levels from this study is expected in Q3 2024, including results from the 600 mg cohort [1][2] Study Details - Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study assessing the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in mCRPC patients who have relapsed or are refractory to approved ARPIs [3] - The study will transition to Phase 2 after evaluating safety and preliminary anti-tumor activity to support optimal dose selection [3] Company Overview - Oncternal Therapeutics is focused on developing novel oncology therapies for cancers with critical unmet medical needs, particularly in hematological malignancies and prostate cancer [4] - ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with preclinical activity against both unmutated and aberrant forms of the androgen receptor, addressing resistance in mCRPC patients [4] - The company is also developing ONCT-808, an investigational CAR T cell therapy targeting ROR1, which has shown activity in preclinical models against various cancers [4]
Oncternal Announces Enrollment Completed and Dosing Initiated for Fifth Dose Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer