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

A Phase 1/2 Dose Escalation Trial With Administration Schedule Exploration Evaluating Single Agent TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Patients With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-Resistant Prostatic Cancer
• Intervention / Treatment: Drug: TD001

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: TOAD Clinical Operations; Phone Number: 41 41 556 64 01; Email: contact@toadonco.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonie
  • Paris, France, 75014
    • Recruiting
    • Hôpital Paris Saint Joseph
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron Institute of Oncology
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Not yet recruiting
      • Yale University, Yale Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation; Sequential groups of participants receive TD001 at escalating doses	Drug: TD001; Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment
Experimental: RP2D dose expansion; Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds)	Drug: TD001; Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK - AUC	Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
Plasma PK - AUClast	Area under concentration-time curve from time zero to the last measurable concentration for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
Plasma PK - Cmax	Maximum concentration for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
Plasma PK - Tmax	Time to maximum concentration for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
Plasma PK - T1/2	Terminal elimination half-life for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
Plasma PK - Ctrough	Trough concentration for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
PSA progression-free survival	Per PCWG3	Treatment + follow-up (estimated 21 months)
Radiographic progression-free survival	per PCWG3-modified RECIST 1.1	Treatment + follow-up (estimated 21 months)
Duration of response	For PSA and radiographic response	Treatment + follow-up (estimated 21 months)
Disease control rate	Best response of CR, PR or SD	Treatment (estimated 8 months)
Overall survival		Treatment + follow-up (estimated 21 months)
Immunogenicity - prevalance and incidence of ADAs	ADAs against TD001 prior to first dose and at any time on treatment	Treatment period + follow-up (estimated 9 months)
Plasma PK - AUCtau	Area under concentration-time curve from time zero to the end of the dosing interval for total ADC, total antibody, and unconjugated payload	Estimated 6-8 months
PSA50 response rate	≥50% PSA decrease from baseline, per PCWG3	Treatment (estimated 8 months)
Overall response rate	Best response of CR or PR per PCWG3-modified RECIST 1.1	Treatment (estimated 8 months)

Collaborators and Investigators

• Sponsor: T.O.A.D. Oncology SA

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PSMA; prostate-specific membrane antigen; CRPC
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
• Other Study ID Numbers: TD001-101; 2025-523273-41-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No