Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

Launched by NOVARTIS PHARMACEUTICALS · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called [225Ac]Ac-PSMA-R2 for men with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and is no longer responding to standard hormone therapies. The goal is to understand how safe this new treatment is, how well it works against the cancer, and how it behaves in the body. The trial is open to men aged 65 to 74 who have been diagnosed with PSMA-positive mCRPC and have had previous treatments, including certain types of radiation therapy.

To participate, men must have shown that their cancer is progressing and have adequate organ function. They should also have undergone either surgical removal of the testicles or be on ongoing hormone therapy. However, men who have received other cancer treatments recently or have certain health issues, like serious heart problems or other active cancers, may not be eligible. Participants can expect to receive the new treatment and be monitored for its effects, including any side effects or changes in their cancer. This study is currently recruiting participants, and it aims to provide valuable information that could help improve treatment options for men with this challenging condition.

Gender

MALE

Eligibility criteria

• 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.