Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Launched by NOVARTIS PHARMACEUTICALS · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called AAA817 for men with prostate cancer that has come back after previous therapies. Specifically, it is for adult men who have a specific type of prostate cancer known as PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and have already undergone treatments like hormone therapy and chemotherapy. The trial will compare how effective AAA817 is against the standard treatments currently available.

To participate in this study, men must be at least 18 years old and have confirmed prostate cancer that has progressed after receiving certain prior treatments. They should also have a specific level of testosterone and show signs of cancer spread in imaging tests. Participants will receive either the new treatment or the standard care chosen by their doctor. The trial is currently recruiting, and it aims to find out if AAA817 can help improve outcomes for these patients. Joining the study may provide access to new treatment options and contribute to important research in prostate cancer care.

Gender

MALE

Eligibility criteria

• • Inclusion Criteria: ∙
• • adults ≥ 18 years of age.
• • ECOG performance status of 0 to 2.
• • histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
• • PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
• • castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
• • Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy.
• • ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
• • eGFR as requested by the sponsor
• Exclusion Criteria:
• • Any investigational agents within 28 days prior to the day of randomization.
• • Any 225Ac-based investigational compound used prior to the day of randomization.
• • Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• • Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
• • Baseline xerostomia ≥ Grade 2 by CTCAE v.5
• • History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
• • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
• • Other protocol-defined inclusion/exclusion criteria may apply.