RecruitingPhase 1Phase 2NCT07258407

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

A Phase 1/2 Dose Escalation Trial With Administration Schedule Exploration Evaluating Single Agent TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Patients With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer


Sponsor

T.O.A.D. Oncology SA

Enrollment

180 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called TD001 — a targeted radiotherapy that homes in on prostate cancer cells using a protein they display on their surface (called PSMA) — in men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (prostate cancer that has spread and stopped responding to hormone therapy) - Your cancer cells express the PSMA protein - You have at least one measurable tumor site - You have already received hormone therapy and at least one androgen receptor pathway inhibitor drug **You may NOT be eligible if...** - You received certain radioactive treatments in the past 6 months - You had recent systemic cancer treatment (within 28 days) - You have known allergy to TD001 or similar compounds - You require continuous oxygen therapy or have severe lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTD001

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


Locations(4)

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Institut Bergonié

Bordeaux, France

Hôpital Paris Saint Joseph

Paris, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT07258407