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RecruitingInterventionalPhase 3

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

NCT ID: NCT07164443Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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 combination with best supportive care (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).

Arms & interventions

  • BiologicalPasritamig

    Pasritamig will be administrated through IV infusion.

  • OtherPlacebo

    Placebo will be administrated through IV infusion.

  • DrugBest Supportive Care (BSC)

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

Outcome measures

Primary

  • Overall Survival (OS)

    OS is defined as the time from randomization to date of death due to any cause.

    Time frame: Up to 2 years and 8 months

Secondary

  • Radiographic Progression-free Survival (rPFS)

    Time frame: Up to 2 years and 8 months

  • Time to Symptomatic Progression

    Time frame: Up to 2 years and 8 months

  • Time to Skeletal-Related Event

    Time frame: Up to 2 years and 8 months

  • Progression-Free Survival (PFS)

    Time frame: Up to 2 years and 8 months

  • Time to Prostate Specific Antigen (PSA) Progression

    Time frame: Up to 2 years and 8 months

  • Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours

    Time frame: Up to 2 years and 8 months

  • Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score

    Time frame: Up to 2 years and 8 months

  • Number of Participants with Adverse Events (AEs)

    Time frame: Up to 2 years and 8 months

  • Number of Participants with Abnormalities in Clinical Laboratory Assessments

    Time frame: Up to 2 years and 8 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 * 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 should 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: Should 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. Participants who cannot continue taxane therapy because of a documented Grade\>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment Radioligand therapy: Should 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): Should 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 \>= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (\<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin \<= 3 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 locations (50)

University of California at San Diego

La Jolla, California, 92093

Recruiting

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095

Recruiting

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012

Recruiting

University of Colorado Cancer Center

Aurora, Colorado, 80045

Recruiting

Colorado Clinical Research

Lakewood, Colorado, 80228

Recruiting

Hartford Hospital

Hartford, Connecticut, 06102

Recruiting

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016

Recruiting

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744

Recruiting

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Recruiting

Mission Cancer Blood

Waukee, Iowa, 50263

Recruiting

East Jefferson General Hospital

Metairie, Louisiana, 70006

Recruiting

Johns Hopkins University

Baltimore, Maryland, 21287

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Recruiting

University of Michigan Health System

Ann Arbor, Michigan, 48109

Recruiting

Henry Ford Cancer Detroit

Detroit, Michigan, 48202

Recruiting

University Of Minnesota Medical Center

Minneapolis, Minnesota, 55455

Recruiting

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130

Recruiting

NYU Langone Hospitals

Brooklyn, New York, 11220

Recruiting

NYU Langone Hospital Long Island

Mineola, New York, 11501

Recruiting

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016

Recruiting

Columbia University Medical Center

New York, New York, 10032

Recruiting

University of Cincinnati

Cincinnati, Ohio, 45219

Recruiting

University Hospital of Cleveland

Cleveland, Ohio, 44106

Recruiting

Compass Oncology

Portland, Oregon, 97227

Recruiting

VA Portland Health Care System

Portland, Oregon, 97239

Recruiting

Oregon Urology Institute

Springfield, Oregon, 97477

Recruiting

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

Recruiting

Keystone Urology Specialists

Lancaster, Pennsylvania, 17601

Recruiting

Penn Medicine Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232

Recruiting

Ralph H Johnson Veterans Hospital

Charleston, South Carolina, 29401

Recruiting

Gibbs Cancer Center and Research Institute Pelham

Greer, South Carolina, 29650

Recruiting

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting

Gibbs Cancer Center

Spartanburg, South Carolina, 29303

Recruiting

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404

Recruiting

Tennessee Oncology Nashville

Nashville, Tennessee, 37203

Recruiting

Urology Clinics of North Texas

Dallas, Texas, 75231

Recruiting

UT Southwestern Medical Center

Dallas, Texas, 75390

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Michael E DeBakey VA Medical Center

Houston, Texas, 77030

Recruiting

Texas Oncology West Texas

Wichita Falls, Texas, 76310

Recruiting

Utah Cancer Specialists

Salt Lake City, Utah, 84106

Recruiting

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

Blue Ridge Cancer Care

Roanoke, Virginia, 24014

Recruiting

VA Puget Sound Healthcare System

Seattle, Washington, 98108

Recruiting

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Recruiting

University of Washington

Seattle, Washington, 98195

Recruiting