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

Condition(s) studied

Investigational drug(s) / intervention(s)

TD001: Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

Study summary

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).

Eligibility

Primary outcome measure(s)

• Maximum tolerated dose (dose escalation) — Treatment + follow-up (estimated 9 months)
  Number of participants with dose-limiting toxicity; incidence of adverse events (AEs), serious AEs (SAEs), abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0
• Recommended Phase 2 doses (dose escalation) — Treatment + follow-up (estimated 9 months)
  Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0
• Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion) — Treatment + follow-up (estimated 21 months)
  AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0
• Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion) — Treatment + follow-up (estimated 21 months)
  AEs by type, severity, and relatedness as assessed by CTCAE v6.0

Trial sites (7)