NCT07258407RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 30 Jan 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- T.O.A.D. Oncology SA
- Diseases
- Prostate cancer
- NCT number
- NCT07258407
- EU CT number
- 2025-523273-41-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 180
- From 30 Jan 2026 to the primary completion date, 31 Mar 2028
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Yale University, Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.