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

NCT ID: NCT07258407

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-03-31

Brief 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.

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalation

Sequential groups of participants receive TD001 at escalating doses

Group Type: EXPERIMENTAL

TD001

Intervention Type: DRUG

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

RP2D dose expansion

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

Group Type: EXPERIMENTAL

TD001

Intervention Type: DRUG

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

Interventions

TD001

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

T.O.A.D. Oncology SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Countries

United States

Central Contacts

TOAD Clinical Operations

Role: CONTACT

contact@toadonco.com

41 41 556 64 01

Other Identifiers

2025-523273-41-00

Identifier Type: CTIS

Identifier Source: secondary_id

TD001-101

Identifier Type: -

Identifier Source: org_study_id