Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Launched by NOVARTIS PHARMACEUTICALS · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for men with metastatic castration-resistant prostate cancer (mCRPC) that is positive for a specific protein called PSMA. The researchers want to find out if a treatment combining a drug called AAA817 with an androgen receptor pathway inhibitor (ARPI) can help patients live longer without their cancer getting worse compared to standard treatments, which may include a different ARPI or chemotherapy. The trial will involve up to six cycles of AAA817, and it's currently not recruiting participants.

To be eligible for this trial, participants must be adult men aged 18 or older who have been diagnosed with prostate cancer and have not received certain previous treatments, specifically taxane chemotherapy or PSMA-targeting therapies. They also need to have a specific type of advanced prostate cancer that is still growing despite other treatments. Participants can expect to receive the new treatment and will be closely monitored throughout the trial. It's important to note that some individuals may not qualify due to prior treatments or other health issues.

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • Signed informed consent must be obtained prior to participation in the study.
• • Participants must be adults ≥ 18 years of age.
• • Participants must have an ECOG performance status of 0 to 2.
• • Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
• • Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
• • Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.
• • Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).
• Key Exclusion Criteria:
• • Previous treatment with any approved or investigational RLT, approved or investigational radioisotopes
• • Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
• • Participants with known or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
• • Any approved or investigational agents/systemic anti-cancer therapy (e.g. other chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) within 28 days (or 5 times the half-life of that therapy whichever is longer) of the anticipated day C1D1.
• • Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment.
• • Other protocol-defined inclusion/exclusion criteria may apply.