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
About This Trial
- This study is testing a new targeted drug called TD001 to see how safe it is and how well it helps control advanced prostate cancer.
- It is designed for men whose cancer has spread to other areas, continues to grow despite standard hormone therapies, and has a specific protein on the cancer cells called PSMA.
- To be eligible, you must have already received certain hormone-blocking medications and have cancer spots that doctors can measure on scans.
- You may not be able to join if you have received certain types of radiation therapy within the past six months or if you have a history of serious lung or breathing issues.
More Information
- 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 Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing a new targeted drug called TD001 to see how safe it is and how well it helps control advanced prostate cancer.
Study Details
- Start Date: January 30, 2026
- Lead Sponsor: T.O.A.D. Oncology SA
Full Eligibility 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
Treatments
- Drug: TD001