Phase 12 Study of TD001, a PSMA-Targeted Antibody-Drug Conjugate, for Men with Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating TD001, an antibody-drug conjugate targeting prostate-specific membrane antigen PSMA, in men with metastatic PSMA-expressing castration-resistant prostate cancer CRPC. This first-in-human, open-label, multicenter Phase 12 trial aims to assess the safety, tolerability, drug levels, and preliminary antitumor activity of TD001 to support dose optimization for further study. Participants receive TD001 through intravenous infusion at escalating doses to find the recommended Phase 2 doses RP2Ds. Multiple dosing schedules may be tested during the dose escalation part, followed by an expansion phase where groups receive TD001 at the RP2Ds until disease progression or other reasons to stop treatment. During the study, participants will be closely monitored for safety and tolerability, including adverse events and laboratory tests, over treatment and follow-up periods ranging from approximately 8 to 21 months. Researchers will measure pharmacokinetics, response rates, progression-free survival, overall survival, and immunogenicity. The total estimated follow-up includes up to 21 months to capture treatment effects and long-term safety.

A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer