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
- Barcelona, SpainSee the site
- Phase
- Phase 1/2
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking 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?
Trial 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.