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

T.O.A.D. Oncology SA

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Metastatic Castration-Resistant Prostatic Cancer

Treatments: Drug: TD001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07258407

2025-523273-41-00 (EU Trial (CTIS) Number)

TD001-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Dose escalation

Experimental group

Description:

Sequential groups of participants receive TD001 at escalating doses

Treatment:

Drug: TD001

RP2D dose expansion

Experimental group

Description:

Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds)

Treatment:

Drug: TD001