Actively Recruiting
A Phase 12 Dose Escalation Trial Exploring Dosing of TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Men With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer
Led by T.O.A.D. Oncology SA · Updated on 2026-05-29
180
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TD001, an antibody-drug conjugate targeting prostate-specific membrane antigen PSMA, in men with metastatic PSMA-expressing castration-resistant prostate cancer CRPC. This first-in-human, open-label, multicenter Phase 12 trial aims to assess the safety, tolerability, drug levels, and preliminary antitumor activity of TD001 to support dose optimization for further study. Participants receive TD001 through intravenous infusion at escalating doses to find the recommended Phase 2 doses RP2Ds. Multiple dosing schedules may be tested during the dose escalation part, followed by an expansion phase where groups receive TD001 at the RP2Ds until disease progression or other reasons to stop treatment. During the study, participants will be closely monitored for safety and tolerability, including adverse events and laboratory tests, over treatment and follow-up periods ranging from approximately 8 to 21 months. Researchers will measure pharmacokinetics, response rates, progression-free survival, overall survival, and immunogenicity. The total estimated follow-up includes up to 21 months to capture treatment effects and long-term safety.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Ability to understand study requirements and provide informed consent
- Diagnosis of PSMA-expressing metastatic castration-resistant prostate cancer with documented progression
- At least one measurable metastatic lesion per RECIST 1.1 criteria
- Adequate organ function
- Prior orchiectomy and/or ongoing androgen deprivation therapy
- Prior treatment with at least one androgen receptor pathway inhibitor drug
You will not qualify if you...
- Previous treatment with certain radiopharmaceuticals or hemi-body irradiation within 6 months before treatment
- Systemic anticancer therapy including investigational agents within 28 days before treatment
- Known hypersensitivity to TD001, its analogs, or excipients
- Current dyspnea at rest, need for continuous oxygen therapy, or history of pneumonitis
Research Team
T
TOAD Clinical Operations
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