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:

  1. may apply.

View trial on ClinicalTrials.gov