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RECRUITING

NCT07164443

PHASE3

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1203

Start Date

2025-09-02

Completion Date

2028-08-18

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Metastatic Castration-resistant Prostatic Neoplasms

Interventions

BIOLOGICAL

Pasritamig

Pasritamig will be administrated through IV infusion.

OTHER

Placebo

Placebo will be administrated through IV infusion.

DRUG

Best Supportive Care (BSC)

BSC will be administered at the discretion of the treating physician.

BIOLOGICAL

JNJ-87189401

JNJ-87189401 will be administered.

Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate * Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan. Visceral disease is not allowed * PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening * In the opinion of the investigator, the next best treatment option is a clinical trial * Participants are required to have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI Taxanes: Required to have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: 1. Cabazitaxel is not available 2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period Radioligand therapy: Required to have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: 1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. 2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Required to have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available * Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \[agonist or antagonist\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Participants are eligible if they have the following values: A) eGFR ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin \<1.5 times ULN D) Absolute neutrophil count (ANC) ≥ 1.0x10\^9/per liter (L) E) Hemoglobin ≥ 8.0 grams per deciliter (g/dL) F) Platelet count ≥ 75x10\^9/L Exclusion Criteria * Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary * Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus) * Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\<38ºC) at the time of study treatment dosing unless approved by medical monitor * Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation * Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Any of the following within 6 months prior to first dose of study treatment: A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident \- Prior treatment with any CD3-directed therapy

Locations (176)

University of California at San Diego

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

San Francisco VA Medical Center

San Francisco, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Mission Cancer Blood

Waukee, Iowa, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Henry Ford Cancer Detroit

Detroit, Michigan, United States

University Of Minnesota Medical Center

Minneapolis, Minnesota, United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States

NYU Langone Hospitals

Brooklyn, New York, United States

NYU Langone Hospital Long Island

Mineola, New York, United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Compass Oncology

Portland, Oregon, United States

Oregon Health And Science University

Portland, Oregon, United States

VA Portland Health Care System

Portland, Oregon, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Penn Medicine Abramson Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Ralph H Johnson Veterans Hospital

Charleston, South Carolina, United States

Gibbs Cancer Center and Research Institute Pelham

Greer, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Gibbs Cancer Center

Spartanburg, South Carolina, United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Texas Oncology West Texas

Wichita Falls, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Warringal Private Hospital

Heidelberg, Australia

ICON Cancer Care

Kurralta Park, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

AZ Sint-Jan

Bruges, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Ghent University Hospital

Ghent, Belgium

Az Groeninge

Kortrijk, Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, Belgium

CHC MontLegia

Liège, Belgium

Clinique Saint Pierre

Ottignies, Belgium

ZAS Augustinus

Wilrijk, Belgium

Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

Florianópolis, Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

CHU de Quebec Universite Laval

Québec, Quebec, Canada

Peking University First Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

The Third People's Hospital of Chengdu

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Sun Yat Sen University Cancer Center

Guangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Nantong Tumor Hospital

Nantong, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Fudan University Shanghai Cancer Center

Shanghai, China

The Second Hospital Of Tianjin Medical University

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Zhongnan Hospital Wu Han University

Wuhan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Institut Bergonie

Bordeaux, France

CHRU Brest - Hopital Morvan

Brest, France

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

And 76 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (176)