According to a press release on globenewswire.com, the biopharmaceutical company Oncternal Therapeutics, Inc., announced the completion of enrollment and initial dosing for the sixth cohort of its early-stage clinical trial. This trial is evaluating the organization’s investigational therapy ONCT-534 as a treatment for individuals living with relapsed or refractory metastatic castration-resistant prostate cancer. Specifically, these patients have experienced relapse following treatment with androgen receptor pathway inhibitors (ARPI).
About The Trial
Study ONCT-534-101, categorized as a Phase 1/2 trial, is an open label, single arm, multicenter trial. In the first phase, tolerability, safety, pharmacokinetics, and preliminary anti-tumor behavior of ONCT-534 will be assessed. The second phase will further evaluate the anti-tumor action and safety aspects of the therapy, with the goal of determining the optimal dose level. At the sixth level dose cohort, the patients will receive a 1200 mg dosage, to be administered one per day and taken orally. The decision to proceed with this cohort was made following the evaluation of data from the fifth cohort, which had a dose level of 600 mg daily.
About ONCT-534
So far in the trial, the investigational therapy has been well-tolerated, and so far the trial hasn’t revealed any toxicities that would limit the dose. The drug is classified as a dual-action inhibitor of the androgen receptor.
About Metastatic Castration-Resistant Prostate Cancer
Prostate cancer occurs in the prostate gland, part of the male reproductive system that is positioned beneath the bladder. Metastatic castration-resistant prostate cancer refers to advanced disease that has spread to other areas of the body and is resistant to androgen deprivation therapy (‘chemical castration’). Risk factors for prostate cancer include old age, a family history of the disease, and being of African ancestry. Tumors can appear on the prostate as cells accumulate DNA mutations, but most do not become cancerous. In early stages, prostate cancer doesn’t cause symptoms, but as the disease progresses, difficulty urinating, erectile dysfunction, and bloody urine or semen can appear. Fatigue, bone or back pain, or unexpected weight loss are signs of metastatic disease. Treatment for prostate cancer can vary widely depending on risk and severity of the individual case. Options can include surgical removal of the prostate, hormone therapy, or radiation therapy. Chemotherapy is often used when the disease has spread. Due to screening programs, prostate cancer is often detected at an early stage, and in these cases, patients can have relatively long survival times after diagnosis. To learn more about prostate cancer, click here.
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clinical trial MCRPC metastatic castration-resistant prostate cancer prostate cancer research treatment
Last modified: August 19, 2024
