Phase 2 Trial Assessing CPI-1205, Plus Xtandi, Begins Dosing Metastatic CRPC Patients

Phase 2 Trial Assessing CPI-1205, Plus Xtandi, Begins Dosing Metastatic CRPC Patients
Constellation Pharmaceuticals has begun patient dosing in the second part of a Phase 1b/2 trial testing its investigational inhibitor CPI-1205, in combination with Xtandi (enzalutamide), for the second-line treatment of metastatic castration-resistant prostate cancer patients (mCRPC), the company announced. The ProSTAR trial (NCT03480646) was also expanded to include a third group in its Phase 2 part, which will test a combination of CPI-1205 plus Zytiga (abiraterone acetate) and prednisone in a similar patient population. The trial is continuing to recruit patients at sites across the U.S. The decisions come after encouraging Phase 1b results, where CPI-1205 was well-tolerated by patients and showed preliminary signs of effectiveness. “We are pleased that CPI-1205 achieved its Phase 1b endpoints in ProSTAR, demonstrating an encouraging safety profile and evidence of clinical activity,” Adrian Senderowicz, chief medical officer of Constellation Pharmaceuticals, said in a press release. “As we advance into the Phase 2 portion of the study, we believe combination therapy with CPI-1205 may provide a meaningful second-line treatment option to patients with metastatic castration-resistant prostate cancer, an area of significant unmet medical need." In early stages, prostate cancer is dependent on testosterone to grow. Patients who cannot receive surgery or radiation are thus treated with a kind of approach called androgen deprivation therapy, which lowers testosterone to undetectable levels. Initial responses to hormone therapy are usually encouraging, but nearly half of patients acquire resistance, meaning their cancer is able to grow even with very low testosterone levels. At this point, they are considered to have castration-resistant prostate cancer
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