Informations générales (source: ClinicalTrials.gov)
SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy (SatisfACtion)
Interventional
Phase 1/Phase 2
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
novembre 2023
novembre 2029
10 mai 2025
This is an open label, phase I/II, multi-center study in adult participants with
metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration
resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have
a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study
drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated
patients.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Novartis Investigative Site - 21034 - Dijon - Cote D Or - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 44093 - Nantes Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 54511 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined
by central reading
- Documented progressive mCRPC or mHSPC
- Adequate organ function
- Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT
(Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 and
Group 3 dose escalation & expansion).
Key
- Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined
by central reading
- Documented progressive mCRPC or mHSPC
- Adequate organ function
- Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT
(Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 and
Group 3 dose escalation & expansion).
Key
- Any other investigational agents within 28 days of the anticipated C1D1 of
225Ac-PSMA-R2 therapy
- Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of
225Ac-PSMA-R2 therapy
- Uncontrolled pain or incompatibility that may result in participant's lack of
ability to comply with imaging procedures
- History of CNS metastases and symptomatic cord compression, or clinical or
radiologic findings indicative of impending cord compression
- History of myocardial infarction, angina pectoris, or coronary artery bypass graft
within 6 months prior to ICF signature and/or clinically active significant cardiac
disease
- Diagnosis of other malignancies in the past three years expected to alter life
expectancy or may interfere with disease assessment
Other protocol-defined inclusion/exclusion criteria may apply.