A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastati
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).
| Condition(s) | Metastatic Castration-Resistant Prostatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | 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, |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | T.O.A.D. Oncology SA |
| Locations | New Haven, Connecticut, United States; Melbourne, Victoria, Australia; Toronto, Ontario, Canada; Bordeaux, France; Paris, France; Villejuif, France (+1 more sites) |
| Start date | 2026-01-30 |
| NCT ID | NCT07258407 |
| Official listing | https://clinicaltrials.gov/study/NCT07258407 |