Recruiting
Phase 3

Pasritamig with BSC

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07164443

Conditions

Metastatic Castration-resistant Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pasritamig

Placebo

Best Supportive Care (BSC)

JNJ-87189401

Study Details

Brief 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).

Conditions

Metastatic Castration-resistant Prostatic Neoplasms

Study ID

NCT07164443

Start date

Sep 2, 2025

Status verified date

Aug, 2026

Completion date

Aug 18, 2028

Anticipated

Primary completion date

Aug 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1203 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Pasritamig+Best Supportive Care (BSC)

Participants in Part 1 will receive 2 step-up doses of pasritamig intravenously (IV) followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

placebo comparator: Part 1: Placebo+BSC

Participants in Part 1 will receive 2 step-up doses of placebo IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

experimental: Part 2: Pasritamig+BSC

Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

experimental: Part 2: Pasritamig+JNJ-87189401+BSC

Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. JNJ-87189401 will be administered with the first target dose of pasritamig. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

placebo comparator: Part 2: Placebo +BSC

Participants in Part 2 will receive 2 step-up doses of placebo IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

Interventions

Pasritamig

Pasritamig will be administrated through IV infusion.

Placebo

Placebo will be administrated through IV infusion.

Best Supportive Care (BSC)

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

JNJ-87189401

JNJ-87189401 will be administered.

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to 2 years and 8 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of California at San Diego

Recruiting

La Jolla, California, United States, 92093

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Bay Pines VA Healthcare System

Recruiting

Bay Pines, Florida, United States, 33744

Florida Cancer Specialists & Research Institute

Recruiting

Fort Myers, Florida, United States, 33901

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Mission Cancer Blood

Recruiting

Waukee, Iowa, United States, 50263

East Jefferson General Hospital

Recruiting

Metairie, Louisiana, United States, 70006

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Cancer Detroit

Recruiting

Detroit, Michigan, United States, 48202

University Of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

XCancer Omaha / Urology Cancer Center

Recruiting

Omaha, Nebraska, United States, 68130

NYU Langone Hospitals

Recruiting

Brooklyn, New York, United States, 11220

NYU Langone Hospital Long Island

Recruiting

Mineola, New York, United States, 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

University Hospital of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

VA Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Oregon Urology Institute

Recruiting

Springfield, Oregon, United States, 97477

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17601

Penn Medicine Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

UPMC Cancer Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Ralph H Johnson Veterans Hospital

Recruiting

Charleston, South Carolina, United States, 29401

Gibbs Cancer Center and Research Institute Pelham

Recruiting

Greer, South Carolina, United States, 29650

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Gibbs Cancer Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Tennessee Oncology - Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology Nashville

Recruiting

Nashville, Tennessee, United States, 37203

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Michael E DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology West Texas

Recruiting

Wichita Falls, Texas, United States, 76310

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Blue Ridge Cancer Care

Recruiting

Roanoke, Virginia, United States, 24014

VA Puget Sound Healthcare System

Recruiting

Seattle, Washington, United States, 98108

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

BC Cancer Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Lakeridge Health

Recruiting

Oshawa, Ontario, Canada, L1G2B9

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C1

CHU de Quebec Universite Laval

Recruiting

Québec, Quebec, Canada, G1J 1Z4

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.