TD001 for Men With Metastatic Prostate Cancer That Has Stopped Responding to Hormone Therapy
Tests the safety of TD001 in men with PSMA-expressing metastatic castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
Key facts
- Where
- Bordeaux, Paris, and Villejuif, FranceSee the 3 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread, no longer responds to hormone-lowering treatment, and carries the PSMA marker.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic castration-resistant prostate cancer (it has spread and keeps growing despite hormone-lowering treatment), with PSMA on the cancer cells. Growth shown by PSA blood level, scans and/or bone disease. At least one lesion that can be measured on scans.
- Earlier treatment
- Must have had at least one androgen receptor pathway inhibitor (ARPI) drug. Must have had testicle removal surgery and/or be on ongoing androgen deprivation therapy.
- Biomarker or test result
- The cancer must express PSMA.
Main reasons for not taking part
- Treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223 or hemi-body irradiation within 6 months before treatment
- Any cancer drug treatment, including an investigational drug, within 28 days before treatment
- Known allergy to TD001, its analogs or its other ingredients
- Breathlessness at rest, another disease needing continuous oxygen, or a history of pneumonitis
- Poor organ function
Read by machine on 12 November 2026.
Where in France
- Institut BergonieBordeaux, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- T.O.A.D. Oncology SA
- Trial code
- NCT07258407EU 2025-523273-41-00
- Record updated
- 29 May 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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.