A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
Start Date
1/30/2026
Completion Date
3/1/2029
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).
Detailed Description
This is a first-in-human, open-label, multicenter Phase 1/2 study with a dose escalation part to determine recommended Phase 2 doses (RP2Ds) of TD001 for further evaluation in an expansion part of the study. Multiple dosing schedules may be evaluated. The safety and preliminary efficacy endpoints of this study will support dose optimization in this patient population.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TD001
Conditions
Locations
Yale University, Yale Cancer Center
New Haven, Connecticut 06520
United States
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Institut Bergonié
Bordeaux, 33076
France
Hôpital Paris Saint Joseph
Paris, 75014
France
Institut Gustave Roussy
Villejuif, 94805
France
Vall d'Hebron Institute of Oncology
Barcelona, 08035
Spain