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

Recruiting now · Phase 1/Phase 2

Conditions studied: Metastatic Castration-Resistant Prostatic Cancer

In brief

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).

Key facts

Study ID

NCT07258407

Run by

T.O.A.D. Oncology SA

People needed

180

Starts

2026-01-30

Expected to finish

2029-03-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient must fully understand the study requirements and voluntarily sign informed consent.
• PSMA-expressing metastatic CRPC with documented progression based on serum PSA, RECIST 1.1 with PCWG3, and/or bone disease.
• At least one measurable metastatic lesion per RECIST 1.1.
• Adequate organ function.
• Prior orchiectomy and/or ongoing androgen deprivation therapy.
• Prior treatment with at least one androgen receptor pathway inhibitor (ARPI) drug.

You may not qualify if…

• Previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation, within 6 months before treatment.
• Systemic anticancer therapy including an investigational agent within 28 days before treatment.
• Known hypersensitivity to the components of TD001, its analogs, or excipients.
• Current dyspnea at rest, other disease requiring continuous oxygen therapy, or history of pneumonitis

Where it is running

• Institut Bergonié — Bordeaux, France (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Vall d'Hebron Institute of Oncology — Barcelona, Spain (enrolling)
• Hôpital Paris Saint Joseph — Paris, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• Yale University, Yale Cancer Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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