First Patient in Phase 1/2 ONCT-534 Study for Relapsed mCRPC Treated

Oncternal Therapeutics, a company in the clinical stage of biopharmaceutical development, has recently reached a significant milestone in its Phase 1/2 clinical trial for ONCT-534, a novel drug designed for advanced prostate cancer patients. The first participant has been administered the drug at a higher dosage of 300 mg per day, following the recommendation of the Safety Review Committee. This decision was based on the positive safety profile observed in the lower dosages and the anticipation that the higher dose may fall within the effective range for combating tumors.

Salim Yazji, the Chief Medical Officer at Oncternal Therapeutics, expressed optimism regarding the drug's tolerability and potential antitumor effects, noting that the company has witnessed a strong interest from both investigators and patients to join the study. The company is enrolling participants at a rapid pace and aims to release preliminary data on the drug's efficacy and safety by the end of the current quarter.

The study, known as ONCT-534-101, is a single-arm, open-label, multi-center trial that is assessing the safety, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in metastatic castration-resistant prostate cancer (mCRPC) patients. The drug is an investigational dual-action androgen receptor inhibitor (DAARI) that has shown preclinical activity against various forms of androgen receptor aberrations, making it a promising candidate for treating mCRPC patients who have developed resistance to existing androgen receptor pathway inhibitors.

Oncternal Therapeutics is dedicated to developing innovative oncology therapies for cancers with significant unmet medical needs, with a focus on hematological malignancies and prostate cancer. The company's pipeline includes ONCT-534, which targets patients with mCRPC who have not responded to other treatments, and ONCT-808, an autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). This therapy has shown activity against multiple types of cancer in preclinical models and is currently being tested in patients with aggressive B-cell lymphoma.

Additionally, the company is developing zilovertamab, a monoclonal antibody that inhibits the function of ROR1 and has demonstrated promising results in combination with ibrutinib for the treatment of certain types of lymphoma. Oncternal has also established a robust manufacturing process for its CAR T therapy, which could potentially reduce the waiting time for patients compared to currently available CAR T products.