This study will evaluate the safety, tolerability, drug levels (pharmacokinetics) and preliminary antitumor activity of TD001, an antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA), in men with metastatic PSMA-expressing castration-resistant prostate cancer (CRPC).
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Maximum tolerated dose (dose escalation)
Timeframe: Treatment + follow-up (estimated 9 months)
Recommended Phase 2 doses (dose escalation)
Timeframe: Treatment + follow-up (estimated 9 months)
Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)
Timeframe: Treatment + follow-up (estimated 21 months)
Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)
Timeframe: Treatment + follow-up (estimated 21 months)