First Patient Dosed in Early Trial Testing ORIC-101, Xtandi Combo for Metastatic Prostate Cancer

First Patient Dosed in Early Trial Testing ORIC-101, Xtandi Combo for Metastatic Prostate Cancer
A Phase 1b trial has started dosing patients to study whether Oric Pharmaceutical’s ORIC-101 — which inhibits the glucocorticoid receptor — is able to overcome prostate cancer resistance to Xtandi (enzalutamide), the company announced. The trial (NCT04033328) is testing a combination of ORIC-101 plus Xtandi in men whose metastatic prostate cancer is progressing while on Xtandi treatment. Ongoing at the Carolina Urologic Research Center, in South Carolina, it is expected to recruit a total of 90 participants. More information on enrollment can be found here. "Despite the introduction of novel antiandrogen therapies for the treatment of prostate cancer, such as enzalutamide, the majority of responsive patients will ultimately become treatment resistant, resulting in poor prognoses for men diagnosed with this devastating condition," Pratik S. Multani, MD, chief medical officer at Oric, said in a press release. "We are excited to evaluate the therapeutic potential of ORIC-101 to overcome what we believe may be a key mechanism of resistance to antiandrogen therapy," Multani added. Xtandi, developed by Astellas Pharma and Pfizer, is a form of hormone therapy that seeks to prevent male hormones from sending chemical signals that stimulate cancer growth; it does so by blocking the activity of their receptor. The treatment is developed for advanced forms of prostate cancer, including those that still respond to androgen receptor therapy (ADT) — a treatment that lowers testosterone levels — and those that don't. Due to its widespread use, resistance to Xtandi has become a major clinical problem. Some studies have identified a mutation in the androgen receptor that renders Xtandi ineffective. But more recently, a team led by Charles Sawyers, MD, Oric
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