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
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT05983198
Sponsor: Novartis Pharmaceuticals
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum 100 Years
- Gender: Male
Key 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 Exclusion Criteria:
- 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.
View trial on ClinicalTrials.gov