Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
T.O.A.D. Oncology SA (Voir sur ClinicalTrials)
février 2026
mars 2029
02 mars 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 27/04/2026 13:05:05 | Contacter | ||
Critères
Homme
- 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