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

NCT07258407 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: TD001-1012025-523273-41-00
• Study Type: interventional
• Target: 180
• Locations: 5 countries
• Sites: 7

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).

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Keywords

CRPC; PSMA; prostate-specific membrane antigen

Outcome Measures

Primary Outcomes (4)

• Maximum tolerated dose (dose escalation)

  Number of participants with dose-limiting toxicity; incidence of adverse events (AEs), serious AEs (SAEs), abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

  Treatment + follow-up (estimated 9 months)

• Recommended Phase 2 doses (dose escalation)

  Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

  Treatment + follow-up (estimated 9 months)

• Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)

  AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0

  Treatment + follow-up (estimated 21 months)

• Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)

  AEs by type, severity, and relatedness as assessed by CTCAE v6.0

  Treatment + follow-up (estimated 21 months)

Secondary Outcomes (15)

• Plasma PK - AUC

  Estimated 6-8 months

• Plasma PK - AUClast

  Estimated 6-8 months

• Plasma PK - AUCtau

  Estimated 6-8 months

• Plasma PK - Cmax

  Estimated 6-8 months

• Plasma PK - Tmax

  Estimated 6-8 months

Study Arms (2)

Dose escalation

EXPERIMENTAL

Sequential groups of participants receive TD001 at escalating doses

Drug: TD001

RP2D dose expansion

EXPERIMENTAL

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

Drug: TD001

Interventions

TD001 DRUG

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

Dose escalation; RP2D dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• T.O.A.D. Oncology SA: lead

Study Sites (7)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Hôpital Paris Saint Joseph

Paris, 75014, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

TOAD Clinical Operations

CONTACT

41 41 556 64 01; contact@toadonco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 + 3 dose escalation design followed by RP2D cohort expansion

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); ES (1); US (1); CA (1); FR (3)