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Recruiting NCT07258407

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

Phase I / Phase II Interventional Metastatic Castration-Resistant Prostatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TD001.
Who it may be relevant to
Registry conditions: Metastatic Castration-Resistant Prostatic Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, France, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug TD001
    Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

Primary outcome measures

  • Maximum tolerated dose (dose escalation) [Time frame: Treatment + follow-up (estimated 9 months)]
  • Recommended Phase 2 doses (dose escalation) [Time frame: Treatment + follow-up (estimated 9 months)]
  • Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion) [Time frame: Treatment + follow-up (estimated 21 months)]
  • Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion) [Time frame: Treatment + follow-up (estimated 21 months)]
Secondary outcome measures (12)
  • Plasma PK - AUC [Time frame: Estimated 6-8 months]
  • Plasma PK - AUClast [Time frame: Estimated 6-8 months]
  • Plasma PK - AUCtau [Time frame: Estimated 6-8 months]
  • Plasma PK - Cmax [Time frame: Estimated 6-8 months]
  • Plasma PK - Tmax [Time frame: Estimated 6-8 months]
  • Plasma PK - T1/2 [Time frame: Estimated 6-8 months]
  • Plasma PK - Ctrough [Time frame: Estimated 6-8 months]
  • PSA50 response rate [Time frame: Treatment (estimated 8 months)]
  • Overall response rate [Time frame: Treatment (estimated 8 months)]
  • PSA progression-free survival [Time frame: Treatment + follow-up (estimated 21 months)]
  • Radiographic progression-free survival [Time frame: Treatment + follow-up (estimated 21 months)]
  • Duration of response [Time frame: Treatment + follow-up (estimated 21 months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Institut Bergonié — Bordeaux
  • Hôpital Paris Saint Joseph — Paris
  • Institut Gustave Roussy — Villejuif
United States · 1 center
  • Yale University, Yale Cancer Center — New Haven
Australia · 1 center
  • Peter MacCallum Cancer Centre — Melbourne
Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto
Spain · 1 center
  • Vall d'Hebron Institute of Oncology — Barcelona

Identifiers

NCT: NCT07258407 · TD001-101 · 2025-523273-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗