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
Start Date
2/27/2025
Completion Date
7/19/2033
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
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
Investigators choice of SoC
AAA817
AAA817
AAA817
Conditions
Locations
VA Greater LA Healthcare System
Los Angeles, California 90073
United States
VA Palo Alto Health Care System
Palo Alto, California 94304-1207
United States
Stanford University Medical Center
Palo Alto, California 94304
United States
Sansum Clinic
Santa Barbara, California 93105
United States
Saint Johns Cancer Institute
Santa Monica, California 90404
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
AdventHealth
Orlando, Florida 32804
United States
University Cancer and Blood Center LLC
Athens, Georgia 30607
United States
Emory University
Atlanta, Georgia 30322
United States
Indiana University
Indianapolis, Indiana 46202
United States
University of Kansas Hospital
Kansas City, Kansas 66160
United States
East Jefferson Hospital
Metairie, Louisiana 70006
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
WA Uni School Of Med
St Louis, Missouri 63110
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68154
United States
New Jersey Urology LLC
Voorhees Township, New Jersey 08043
United States
Associated Med Professionals of NY
Syracuse, New York 13210
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Central Ohio Urology Group
Gahanna, Ohio 43230
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Texas Oncology
Dallas, Texas 75251
United States
Urology San Antonio
San Antonio, Texas 78229
United States
Utah Intermountain Medical Center
Murray, Utah 84107
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-1024
United States
Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
United States
Novartis Investigative Site
Darlinghurst, New South Wales 2010
Australia
Novartis Investigative Site
Herston, Queensland 4029
Australia
Novartis Investigative Site
Melbourne, Victoria 3004
Australia
Novartis Investigative Site
São Paulo, São Paulo 01308-050
Brazil
Novartis Investigative Site
São Paulo, São Paulo 05652-000
Brazil
Novartis Investigative Site
Fuzhou, Fujian 350025
China
Novartis Investigative Site
Wuhan, Hubei 430022
China
Novartis Investigative Site
Wuhan, Hubei 430030
China
Novartis Investigative Site
Nanjing, Jiangsu 210006
China
Novartis Investigative Site
Nanjing, Jiangsu 210029
China
Novartis Investigative Site
Shenyang, Liaoning 110011
China
Novartis Investigative Site
Xian, Shanxi 710032
China
Novartis Investigative Site
Xian, Shanxi 710061
China
Novartis Investigative Site
Chengdu, Sichuan 610041
China
Novartis Investigative Site
Beijing, 100034
China
Novartis Investigative Site
Beijing, 100036
China
Novartis Investigative Site
Guangzhou, 510060
China
Novartis Investigative Site
Shanghai, 200025
China
Novartis Investigative Site
Shanghai, 200032
China
Novartis Investigative Site
Tianjin, 300300
China
Novartis Investigative Site
Hong Kong, 999077
Hong Kong
Novartis Investigative Site
Beersheba, 8457108
Israel
Novartis Investigative Site
Haifa, 3109601
Israel
Novartis Investigative Site
Jerusalem, 9112001
Israel
Novartis Investigative Site
Petah Tikva, 4941492
Israel
Novartis Investigative Site
Ramat Gan, 5265601
Israel
Novartis Investigative Site
Tel Aviv, 6423906
Israel
Novartis Investigative Site
Kashiwa, Chiba 277-8577
Japan
Novartis Investigative Site
Sapporo, Hokkaido 060-8648
Japan
Novartis Investigative Site
Kobe, Hyōgo 6500047
Japan
Novartis Investigative Site
Yokohama, Kanagawa 236-0004
Japan
Novartis Investigative Site
Chiba, 260-8717
Japan
Novartis Investigative Site
Fukuoka, 811-0213
Japan
Novartis Investigative Site
Fukuoka, 812-0033
Japan
Novartis Investigative Site
Fukuoka, 8128582
Japan
Novartis Investigative Site
Fukushima, 9601295
Japan
Novartis Investigative Site
Ishikawa, 9208641
Japan
Novartis Investigative Site
Kyoto, 6068507
Japan
Novartis Investigative Site
Petaling Jaya, Selangor 46050
Malaysia
Novartis Investigative Site
Petaling Jaya, Selangor 46150
Malaysia
Novartis Investigative Site
Singapore, 119228
Singapore
Novartis Investigative Site
Singapore, 168583
Singapore
Novartis Investigative Site
Singapore, 258499
Singapore
Novartis Investigative Site
Seoul, 03080
South Korea
Novartis Investigative Site
Seoul, 03722
South Korea
Novartis Investigative Site
Seoul, 05505
South Korea
Novartis Investigative Site
Seoul, 06591
South Korea
Novartis Investigative Site
Basel, 4031
Switzerland
Novartis Investigative Site
Bellinzona, 6500
Switzerland
Novartis Investigative Site
Bern, 3010
Switzerland
Novartis Investigative Site
Taipei, 10002
Taiwan
Novartis Investigative Site
Taipei, 103616
Taiwan
Novartis Investigative Site
Taipei, 11217
Taiwan
Novartis Investigative Site
Taoyuan, 33305
Taiwan