SatisfACtion: A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With Heavily Pre-treated PSMA Positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy.
Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT05983198
Sponsor: Novartis Pharmaceuticals
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Key Inclusion Criteria:
- Evidence of PSMA-positive disease by 68Ga-PSMA-R2 PET/CT and eligible as determined by central reading
- Documented progressive mCRPC
- Adequate organ function (bone marrow reserve, hepatic, renal)
- Prior orchiectomy and/or ongoing ARPI and taxane-based chemotherapy and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 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
- Uncontrolled cardiovascular history
- Diagnosis of other malignancies expected to alter life expectancy or may interfere with disease assessment Other protocol-defined inclusion/
Exclusion Criteria:
- may apply.
View trial on ClinicalTrials.gov