First Patient Dosed in Phase 1/2 Study of TRC253 for Treating Therapy-resistant Prostate Cancer

First Patient Dosed in Phase 1/2 Study of TRC253 for Treating Therapy-resistant Prostate Cancer
The first patient has been dosed in a Phase 1/2a clinical trial that will assess TRACON Pharmaceuticals’ TRC253 for treating metastatic castration-resistant prostate cancer (mCRPC), a form that has developed resistance against other therapies. TRACON was able to file an Investigational New Drug application with U.S. regulators quickly, "open multiple sites, and dose TRC253 in a Phase 1/2 trial following the establishment of our strategic licensing collaboration with Janssen,” Dr. Charles Theuer, president and CEO of TRACON, said in a press release. "We think TRC253 has the potential to be a best-in-class androgen receptor antagonist, and address an unmet medical need in the treatment of men with metastatic castration-resistant prostate cancer who develop resistance to androgen receptor inhibitors.” The Phase 1/2a trial (NCT02987829) will be a multi-center, first-in-human, open-label, dose-escalation study. It will evaluate TRC253's effectiveness, safety, pharmacodynamics and pharmacokinetics in up to 80 men with mCRPC. Pharmacodynamics refers to how a drug affects the body, while pharmacokinetics refers to how the body impacts a drug. In Phase 1 of the study, patients will receive escalating doses of TRC253 to determine a recommended Phase 2 dose. Phase 1 will also look at how TRC253 affects patients' PSA levels. Levels of PSA, or prostate-specific antigens, are a key biomarker of prostate cancer. Phase 2, the trial’s dose expansion phase, will include two groups of 30 patients each. Cohort 1 will consist of patients with the androgen receptor mutation AR F876L, and Cohort 2 will be patients without the mutation. TRC253 is an androgen receptor antagonist, which means it suppresses androgen receptors. Those taking part in the trial must have
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