TMCnet News
Oncternal Therapeutics Enrolls Patients into the Third Dosing Cohort of its Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate CancerSAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). The last two patients were enrolled into the third dosing cohort, to receive ONCT-534 at a dose of 160 mg taken orally each day. The study utilizes an adaptive Bayesian Optimal Interval (BOIN) design, under which the first two dosing cohorts treated one patient each at 40 mg ONCT-534 per day and 80 mg ONCT-534 per day, respectively. The decision to proceed to dose level 3 was confirmed by the study’s Safety Review Committee (SRC). “The ONCT-534-101 investigators are enthusiastic about this study, and we are excited about the enrollment and progress through the initial dosing levels. Reaching the third cohort represents an important milestone for the program, as we believe we are nearing potentially therapeutic doses that may benefit prostate cancer patients who have progressed after treatment with approved ARPI such as enzalutamide, abiraterone, apalutamide and darolutamide,” said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. “We believe ONCT-534, with its novel mechanism of action involving both the ligand-binding domain and the N-terminal domain of the androgen receptor (AR), may address a significant unmet medical need for patients with advanced metastatic prostate cancer, especially those with splice variants of the AR, mutations in the ligand-binding domain of the AR, or AR amplification, common mechanisms of resistance that may develop to treatment with currently approved AR pathway inhibitors.” About Study ONCT-534-101 About Oncternal Therapeutics ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Forward-Looking Information Contact Information: Investors Media |