Oncternal Advances Phase 1/2 Study of ONCT-534 for Treatment of Metastatic Castration-Resistant Prostate Cancer
Oncternal Therapeutics, Inc. a clinical-stage biopharmaceutical company specializing in the development of innovative oncology therapies, has recently completed enrollment and begun dosing for the fifth dose cohort in its Phase 1/2 study of ONCT-534. This study aims to evaluate the efficacy and safety of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor pathway inhibitors (ARPI).
Metastatic castration-resistant prostate cancer is a challenging and life-threatening condition that occurs when prostate cancer cells continue to grow and spread, despite treatments that lower testosterone levels. Currently, there is an unmet medical need in the treatment of mCRPC patients who have progressed on ARPI therapy. Thus, the development of a novel therapy like ONCT-534 holds promise in addressing this critical gap in patient care.
ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) designed to target cancer cells that have developed resistance to ARPI therapy. By inhibiting both the ligand-binding domain and the AF-1 transcriptional activity of the androgen receptor, ONCT-534 aims to provide a comprehensive and effective treatment option for mCRPC patients.
The decision to proceed to the higher dose level of 600 mg ONCT-534 once daily for the fifth cohort was made by the study’s Safety Review Committee (SRC) after reviewing data from the fourth dose level of 300 mg. This escalation strategy allows researchers to gather vital information about the safety, tolerability, and efficacy of the treatment in a step-by-step manner.
An initial update on the safety and efficacy of ONCT-534, as determined by prostate-specific antigen (PSA) levels, is expected in the third quarter of 2024. This update will include data from the ongoing study, particularly focusing on the patients receiving the 600 mg dose. PSA levels are commonly used as a biomarker to monitor the progression or response to treatment in prostate cancer patients.
The completion of enrollment and the initiation of dosing for the fifth dose cohort represents a significant milestone in the development of ONCT-534. This achievement underscores Oncternal Therapeutics’ commitment to advancing innovative therapies that have the potential to improve patient outcomes in hard-to-treat cancers.
The Phase 1/2 study of ONCT-534 is being conducted in multiple centers across the United States and is expected to enroll approximately 60 patients. The study aims to assess not only the safety and efficacy of the treatment but also important secondary endpoints such as overall response rate, duration of response, and progression-free survival.
The results from this study will provide valuable insights into the potential for ONCT-534 to become a new standard of care for patients with metastatic castration-resistant prostate cancer who have relapsed or are refractory to ARPI therapy. If ONCT-534 demonstrates promising efficacy and an acceptable safety profile, it could potentially offer a much-needed treatment option for this patient population.
In conclusion, the completion of enrollment and initiation of dosing for the fifth dose cohort of the Phase 1/2 study of ONCT-534 is a significant step forward in the development of this novel therapy for metastatic castration-resistant prostate cancer. The upcoming update on safety and efficacy based on PSA levels will provide valuable information to evaluate the potential of ONCT-534 in improving patient outcomes in this challenging disease. Further research and development efforts in this field are crucial to advancing the field of oncology and providing hope for patients with difficult-to-treat cancers.
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