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NCT07258407PHASE1, PHASE2Recruiting

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

T.O.A.D. Oncology SA

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Interventions

DRUG

TD001

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Conditions

Metastatic Castration-Resistant Prostatic Cancer

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