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

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT06780670
Trial Phases:	Phase II Phase III	Protocol IDs:	CAAA817A12201 (primary) NCI-2025-05946 2024-512342-42-00
Eligibility:	18 - 100 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT06780670

Summary

This is a Phase II/III study. Patient population is adult participants with PSMA-positive
mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based
chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.

Treatment of interest: the investigational treatment is AAA817 regardless of subsequent
anti-neoplastic treatment. The control treatment is investigator's choice of Standard of
Care, regardless of subsequent anti-neoplastic treatment

Objectives

Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international,
multicenter, phase II study (Phase II) to collect more information to support the
proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm
phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of
AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult
participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after
[177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this
study is to collect additional information to support proposed phase III dose of AAA817.

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

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