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Clinical Trials in the UK / NCT07164443
Recruiting Phase 3

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

NCT07164443 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-09-02
Last updated
2026-08-28

Condition(s) studied

Metastatic Castration-resistant Prostatic Neoplasms

Investigational drug(s) / intervention(s)

PasritamigPlaceboBest Supportive Care (BSC)JNJ-87189401

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.

Study 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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy 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. 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

Primary outcome measure(s)

Trial sites (173)

FacilityCityRegionStatus
University of California at San Diego La Jolla California Recruiting
Cedars Sinai Medical Center Los Angeles California Recruiting
Ronald Reagan UCLA Medical Center Los Angeles California Recruiting
San Francisco VA Medical Center San Francisco California Recruiting
Rocky Mountain Cancer Centers Aurora Colorado Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Colorado Clinical Research Lakewood Colorado Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Bay Pines VA Healthcare System Bay Pines Florida Recruiting
Florida Cancer Specialists & Research Institute Fort Myers Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
University of Iowa Hospital and Clinics Iowa City Iowa Recruiting
Mission Cancer Blood Waukee Iowa Recruiting
East Jefferson General Hospital Metairie Louisiana Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
Henry Ford Cancer Detroit Detroit Michigan Recruiting
University Of Minnesota Medical Center Minneapolis Minnesota Recruiting
XCancer Omaha / Urology Cancer Center Omaha Nebraska Recruiting
NYU Langone Hospitals Brooklyn New York Recruiting
NYU Langone Hospital Long Island Mineola New York Recruiting
NYU Langone Health Laura and Isaac Perlmutter Cancer Center New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Levine Cancer Institute Charlotte North Carolina Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
University Hospital of Cleveland Cleveland Ohio Recruiting
Compass Oncology Portland Oregon Completed
VA Portland Health Care System Portland Oregon Recruiting
Oregon Urology Institute Springfield Oregon Recruiting
MidLantic Urology Bala-Cynwyd Pennsylvania Recruiting
Keystone Urology Specialists Lancaster Pennsylvania Recruiting
Penn Medicine Abramson Cancer Center Philadelphia Pennsylvania Recruiting
UPMC Cancer Centers Pittsburgh Pennsylvania Recruiting
Ralph H Johnson Veterans Hospital Charleston South Carolina Recruiting
Gibbs Cancer Center and Research Institute Pelham Greer South Carolina Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina Recruiting
Gibbs Cancer Center Spartanburg South Carolina Recruiting

+ 133 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164443 on ClinicalTrials.gov ↗ ← All trials in the UK