Clinical Trials in France / NCT07258407
Recruiting
Phase 1/2
A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
NCT07258407 · tracked via the Priya Life Science France tracker
Condition(s) studied
Metastatic Castration-Resistant Prostatic Cancer
Investigational drug(s) / intervention(s)
TD001
TD001: Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment
Study 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).
Eligibility
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
Primary outcome measure(s)
- Maximum tolerated dose (dose escalation) — Treatment + follow-up (estimated 9 months)
Number of participants with dose-limiting toxicity; incidence of adverse events (AEs), serious AEs (SAEs), abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0 - Recommended Phase 2 doses (dose escalation) — Treatment + follow-up (estimated 9 months)
Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0 - Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion) — Treatment + follow-up (estimated 21 months)
AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0 - Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion) — Treatment + follow-up (estimated 21 months)
AEs by type, severity, and relatedness as assessed by CTCAE v6.0
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University, Yale Cancer Center | New Haven | Connecticut | Not Yet Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| Institut Bergonié | Bordeaux | France | Recruiting |
| Hôpital Paris Saint Joseph | Paris | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Vall d'Hebron Institute of Oncology | Barcelona | Spain | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07258407 on ClinicalTrials.gov ↗ ← All trials in France