TD001 for men with PSMA-expressing metastatic castration-resistant 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
This trial will test whether TD001, a PSMA-targeting antibody-drug conjugate, is safe and can shrink tumors in men with PSMA-expressing metastatic castration-resistant prostate cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | T.O.A.D. Oncology SA Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT07258407 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1/2 trial uses dose escalation to identify recommended Phase 2 doses of TD001 and then an expansion phase to further study safety and preliminary efficacy. Multiple dosing schedules may be tested and pharmacokinetics will be measured to understand drug levels and dosing. Key endpoints include safety, tolerability, drug levels, and early anti-tumor activity such as radiographic responses and PSA changes. Eligible men must have PSMA-expressing metastatic castration-resistant prostate cancer and prior treatment with at least one androgen receptor pathway inhibitor.
Who should consider this trial
Good fit: Ideal candidates are men with PSMA-expressing metastatic castration-resistant prostate cancer who have measurable disease, have progressed after at least one androgen receptor pathway inhibitor, and have adequate organ function.
Not a fit: Patients without PSMA expression, those who received recent radionuclide therapy or other systemic anticancer treatments within exclusion windows, those with active pneumonitis or need for continuous oxygen, or with significant organ dysfunction are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, TD001 could offer a targeted treatment that reduces tumor burden and delays progression in PSMA-positive metastatic CRPC while potentially limiting systemic toxicity compared with conventional chemotherapy.
How similar studies have performed: Other PSMA-targeted therapies, including radioligand treatments and exploratory PSMA-directed ADCs, have shown promising activity in advanced prostate cancer, but TD001 is entering first-in-human testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale University, Yale Cancer Center — New Haven, Connecticut, United States (Not_yet_recruiting)
- Institut Bergonié — Bordeaux, France (Recruiting)
- Hôpital Paris Saint Joseph — Paris, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: TOAD Clinical Operations
- Email: contact@toadonco.com
- Phone: 41 41 556 64 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.