Recruiting

Phase 2

Phase 3

AAA817Open-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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06780670

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Investigators choice of SoC

AAA817

Study Details

Brief 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

Conditions

Prostate Cancer

Study ID

NCT06780670

Start date

Feb 27, 2025

Status verified date

May, 2026

Completion date

Jul 19, 2033

Anticipated

Primary completion date

Jun 27, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

443 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase II: AAA817 Dose B

AAA817 will be given for a number of cycles; a cycle = 8 weeks

active comparator: Phase III: Investigator's choice of SoC

Participants will be given Standard of Care (SOC) treatment per Investigator's choice.

experimental: Phase II: AAA817 Dose A

AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks

experimental: Phase III: Recommended Phase 3 Dose of AAA817

Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks

Interventions

Investigators choice of SoC

The control treatment in Phase III is investigator's choice of SoC

AAA817

The investigational treatment is AAA817

AAA817

The investigational treatment is AAA817

AAA817

Investigational treatment is the Dose B of AAA817

Primary outcome measure

Biochemical response rate (Phase II) [ Time Frame: from date of randomization up to approximately 24 months ]
Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II [ Time Frame: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later ]
Tolerability of the proposed dose of AAA817- Phase II [ Time Frame: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817 ]
Radiographic progression-free survival (rPFS)- Phase III [ Time Frame: from date of randomization up to approximately 24 months ]
Overall survival (OS)- Phase III [ Time Frame: from date of randomization up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

VA Greater LA Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Janake Wijesuriya

janake.wijesuriya@va.gov

Principal Investigator:

Gholam Reza Berenji

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Niko Del Mar

650-493-5000 niko.delmar@va.gov

Principal Investigator:

Minal Vasanawala

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Mikayla Easterling

maeast@stanford.edu

Principal Investigator:

Hong Song

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Jessica Wong

805-563-5800 jessica.wong2@sutterhealth.org

Principal Investigator:

Gregg Newman

Saint Johns Cancer Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Joey Dumadag

310-829-8569 joey.dumadag@providence.org

Principal Investigator:

Przemyslaw Twardowski

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Melanie Manning

Melanie.Manning@hhchealth.org

Principal Investigator:

Andrew Salner

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Joseph Guzzo

407-303-3235 joseph.guzzo@adventhealth.com

Principal Investigator:

Ravi Shridhar

University Cancer and Blood Center LLC

Recruiting

Athens, Georgia, United States, 30607

Contacts

Christen Nicole Cooper Pope

+1 706 353 2990 npope@universitycancer.com

Principal Investigator:

Petros Nikolinakos

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jalpa Patel

+1 404 778 1835 jalpa.r.patel@emory.edu

Principal Investigator:

Shahid Sattar Ahmed.

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Marie Burton

mariburt@iu.edu

Principal Investigator:

Nabil Adra

University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Kelsey Schwensen

kschwensen@kumc.edu

Principal Investigator:

Xinglei Shen

East Jefferson Hospital

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Alexandra Lieberman

alexandra.lieberman@lcmchealth.org

Principal Investigator:

Alton Oliver Sartor

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michael Bonhomme

617-632-5136 michael_bonhomme@dfci.harvard.edu

Principal Investigator:

Xiao Wei.

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Ooviya Sathiyamoorthy

617-643-9923 osathiya@bidmc.harvard.edu

Principal Investigator:

David J Einstein

WA Uni School Of Med

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Collin Welch

314-454-8293 c.welch@wustl.edu

Principal Investigator:

Jeff Michalski

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68154

Contacts

Marlene Bridwell

402-334-4773 mbridwell@nebraskacancer.com

Principal Investigator:

Samuel Mehr

New Jersey Urology LLC

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Gabriela Mercado

856-673-1613 gmercado3@nj-urology.com

Principal Investigator:

Gordon Brown

Associated Med Professionals of NY

Recruiting

Syracuse, New York, United States, 13210

Contacts

Nathan Forrest

nathan.forrest@ampofny.com

Principal Investigator:

Steven Finkelstein

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Tahrima Chowdhury

718-920-6642 tahchowdhu@montefiore.org

Principal Investigator:

Benjamin A Gartrell

Central Ohio Urology Group

Recruiting

Gahanna, Ohio, United States, 43230

Contacts

Sarah Faisal

sarah.faisal@us-uro.com

Principal Investigator:

Benjamin Martin

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Candice Schewbel

215-728-3075 candice.schwebel@fccc.edu

Principal Investigator:

Matthew Zibelman

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Rebecca Floyd

843-839-1679 rebecca.floyd@startresearch.com

Principal Investigator:

Neal D Shore

Texas Oncology

Recruiting

Dallas, Texas, United States, 75251

Contacts

Marian Heaven

512-427-9467 marian.heaven@usoncology.com

Principal Investigator:

Michael P Herman

Urology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Sandra Davila

sandra.davila@usa-clinicaltrials.com

Principal Investigator:

Daniel Saltzstein

Utah Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Becky Arroyo

becky.arroyo@imail.org

Principal Investigator:

David Gill

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-1024

Contacts

Brianna Woo

bwoo@fredhutch.org

Principal Investigator:

Ruben Raychaudhuri

Medical College Of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Nadia Thomas

nathomas@mcw.edu

Principal Investigator:

Deepak Kilari

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

post [177Lu]Lu-PSMA targeted therapy
PSMA-positive
mCRPC adults
Metastatic castration-resistant prostate cancer
AAA817
[225Ac]Ac-PSMA-617
PSMA-based targeted therapy
Standard of Care
SOC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-05-27.