🔎 Trials Near Me

Home › Castration-Resistant Prostatic Cancer › NCT07164443

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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 1,203 · Started: Sep 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07164443

Locations in the U.S.

CaliforniaUniversity of California at San Diego, La Jolla
Cedars Sinai Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center, Los Angeles
San Francisco VA Medical Center, San Francisco
ColoradoRocky Mountain Cancer Centers, Aurora
University of Colorado Cancer Center, Aurora
Colorado Clinical Research, Lakewood
ConnecticutHartford Hospital, Hartford
District of ColumbiaJohns Hopkins Office of Capital Region Research - Sibley Memorial Hospital, Washington D.C.
FloridaBay Pines VA Healthcare System, Bay Pines
Florida Cancer Specialists & Research Institute, Fort Myers
Moffitt Cancer Center, Tampa
IowaUniversity of Iowa Hospital and Clinics, Iowa City
Mission Cancer Blood, Waukee
LouisianaEast Jefferson General Hospital, Metairie
MarylandJohns Hopkins University, Baltimore
MassachusettsDana Farber Cancer Institute, Boston
MichiganUniversity of Michigan Health System, Ann Arbor
Henry Ford Cancer Detroit, Detroit
MinnesotaUniversity Of Minnesota Medical Center, Minneapolis
NebraskaXCancer Omaha / Urology Cancer Center, Omaha
New YorkNYU Langone Hospitals, Brooklyn
NYU Langone Hospital Long Island, Mineola
Columbia University Medical Center, New York
NYU Langone Health Laura and Isaac Perlmutter Cancer Center, New York
North CarolinaLevine Cancer Institute, Charlotte
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
OhioUniversity of Cincinnati, Cincinnati
University Hospital of Cleveland, Cleveland
OregonVA Portland Health Care System, Portland
Oregon Urology Institute, Springfield
PennsylvaniaMidLantic Urology, Bala-Cynwyd
Keystone Urology Specialists, Lancaster
Penn Medicine Abramson Cancer Center, Philadelphia
UPMC Cancer Centers, Pittsburgh
South CarolinaRalph H Johnson Veterans Hospital, Charleston
Gibbs Cancer Center and Research Institute Pelham, Greer
Carolina Urologic Research Center, Myrtle Beach
Gibbs Cancer Center, Spartanburg
TennesseeTennessee Oncology - Chattanooga, Chattanooga
Tennessee Oncology Nashville, Nashville
TexasUT Southwestern Medical Center, Dallas
MD Anderson Cancer Center, Houston
Michael E DeBakey VA Medical Center, Houston
Texas Oncology West Texas, Wichita Falls
UtahUtah Cancer Specialists, Salt Lake City
VirginiaVirginia Cancer Specialists, Fairfax
Virginia Oncology Associates, Norfolk
Blue Ridge Cancer Care, Roanoke
WashingtonFred Hutchinson Cancer Research Center, Seattle
University of Washington, Seattle
VA Puget Sound Healthcare System, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.