AzTrials
AzTrials

Metastatic Castration-resistant Prostatic NeoplasmsPhase 3KLK2-comPASNCT07164443

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

A Phase 3 study testing Pasritamig and JNJ-87189401 in people with Metastatic Castration-resistant Prostatic Neoplasms, run by Janssen Research & Development, LLC at 176 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Pasritamig and JNJ-87189401
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,203 participants
Where
176 sitesin 17 countries
Study dates
2 Sep 2025to 18 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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:
  • Cabazitaxel is not available
  • 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:
  • PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
  • 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:
  • 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

Who cannot join

  • 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:
  • 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

Trial locations and contacts

176 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

176 sites in 17 countries

United States55 sites, 52 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Recruiting

  • NYU Langone Hospitals

    Brooklyn, New York, 11220

    Recruiting

  • Ralph H Johnson Veterans Hospital

    Charleston, South Carolina, 29401

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Recruiting

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106

    Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

    Completed

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Henry Ford Cancer Detroit

    Detroit, Michigan, 48202

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901

    Recruiting

  • Gibbs Cancer Center and Research Institute Pelham

    Greer, South Carolina, 29650

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Michael E DeBakey VA Medical Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • University of California at San Diego

    La Jolla, California, 92093

    Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17601

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Recruiting

  • NYU Langone Hospital Long Island

    Mineola, New York, 11501

    Recruiting

  • University Of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

    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

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • XCancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130

    Completed

  • Penn Medicine Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Compass Oncology

    Portland, Oregon, 97227

    Completed

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • VA Portland Health Care System

    Portland, Oregon, 97239

    Recruiting

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

    Recruiting

  • San Francisco VA Medical Center

    San Francisco, California, 94121

    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

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97477

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Recruiting

  • Mission Cancer Blood

    Waukee, Iowa, 50263

    Recruiting

  • Texas Oncology West Texas

    Wichita Falls, Texas, 76310

    Recruiting

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

China15 sites, 15 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • The Third People's Hospital of Chengdu

    Chengdu, 500643

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Nantong Tumor Hospital

    Nantong, 226300

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • Zhongnan Hospital Wu Han University

    Wuhan, 430071

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

    Recruiting

Other trials in China

Japan14 sites, 14 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812 8582

    Recruiting

  • Gifu University Hospital

    Gifu, 501-1194

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka, 350 1298

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920 8641

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

    Recruiting

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

    Recruiting

  • National Hospital Organization Tokyo Medical Center

    Meguro Ku, 152 8902

    Recruiting

  • Toho University Sakura Medical Center

    Sakura, 285-8741

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060 8648

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Recruiting

  • Yokohama City University Hospital

    Yokohama, 236 0004

    Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, 238 8558

    Recruiting

Other trials in Japan

France11 sites, 11 recruiting

  • Institut Bergonie

    Bordeaux, 33000

    Recruiting

  • CHRU Brest - Hopital Morvan

    Brest, 29200

    Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21000

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Hopital Saint Joseph

    Paris, 75014

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • I.C.O. Rene Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Hopitaux universitaires de Strasbourg

    Strasbourg, 672098

    Recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Germany11 sites, 11 recruiting

  • Staedtisches Klinikum Braunschweig

    Braunschweig, 38126 DE

    Recruiting

  • Urologicum Duisburg

    Duisburg, 47169

    Recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Krankenhaus NorthWest

    Frankfurt am Main, 60488

    Recruiting

  • Martini-Klinik am UKE GmbH

    Hamburg, 20246

    Recruiting

  • Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen

    Heidelberg, 69120

    Recruiting

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675

    Recruiting

  • Universitaetsklinikum Muenster

    Münster, 48149

    Recruiting

  • Klinikum Nuernberg Nord

    Nuremberg, 90419

    Recruiting

  • Studienpraxis Urologie Nurtingen

    Nürtingen, 72622

    Recruiting

Other trials in Germany

Belgium9 sites, 9 recruiting

  • AZ Sint-Jan

    Bruges, 8000

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Recruiting

  • AZ Maria Middelares

    Ghent, 9000

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Recruiting

  • Az Groeninge

    Kortrijk, 8500

    Recruiting

  • Chu Helora Hospital La Louviere Site Jolimont

    La Louvière, 7100

    Recruiting

  • CHC MontLegia

    Liège, 4000

    Recruiting

  • Clinique Saint Pierre

    Ottignies, 1340

    Recruiting

  • ZAS Augustinus

    Wilrijk, 2610

    Recruiting

Other trials in Belgium

Italy8 sites, 8 recruiting

  • Ospedali Riuniti Foggia

    Foggia, 71122

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Recruiting

  • IOV IRCCS Padova

    Padova, 35128

    Recruiting

  • Azienda Di Rilievo Nazionale E Di Alta Specializzazione

    Palermo, 90127

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Torino, 10126

    Recruiting

Other trials in Italy

Netherlands8 sites, 7 recruiting

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD

    Recruiting

  • Martini Ziekenhuis

    Groningen, 9728NT

    Completed

  • Tergooi

    Hilversum, 1212 VG

    Recruiting

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

    Recruiting

  • Maastricht UMC

    Maastricht, 6229 HX

    Recruiting

  • Canisius-Wilhelmina ZH

    Nijmegen, 6532 SZ

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Recruiting

  • Isala Kliniek

    Zwolle, 8025 AB

    Recruiting

Other trials in Netherlands

South Korea7 sites, 7 recruiting

  • Chungnam National University Hospital

    Daejeon, 35015

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasungun, 58128

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

Canada6 sites, 6 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Lakeridge Health

    Oshawa, Ontario, L1G2B9

    Recruiting

  • CHU de Quebec Universite Laval

    Québec, Quebec, G1J 1Z4

    Recruiting

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C1

    Recruiting

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Recruiting

Other trials in Canada

Taiwan6 sites, 6 recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Australia5 sites, 5 recruiting

  • Warringal Private Hospital

    Heidelberg, 3084

    Recruiting

  • ICON Cancer Care

    Kurralta Park, 5037

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

Brazil5 sites, 5 recruiting

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

    Florianópolis, 88020 210

    Recruiting

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

    Joinville, 89201 260

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Recruiting

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

    Recruiting

Other trials in Brazil

Poland5 sites, 5 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276

    Recruiting

  • IN VIVO Sp. z o.o

    Bydgoszcz, 85 048

    Recruiting

  • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

    Koszalin, 75-581

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781

    Recruiting

  • Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

    Warsaw, 04 073

    Recruiting

Other trials in Poland

Spain5 sites, 4 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Completed

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Virgen de La Victoria

    Málaga, 29010

    Recruiting

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Recruiting

  • University College London Hospitals

    London, WC1E 6BT

    Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

    Recruiting

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Puerto Rico2 sites, 2 recruiting

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00935

    Recruiting

  • Puerto Rico Medical Research Center

    San Juan, 00917

    Recruiting

Other trials in Puerto Rico

About this study

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

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).

Being tested
Pasritamig, Placebo, Best Supportive Care (BSC), JNJ-87189401
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PasritamigBiological

    Also called JNJ-78278343

    Pasritamig will be administrated through IV infusion.

  • PlaceboOther

    Placebo will be administrated through IV infusion.

  • Best Supportive Care (BSC)Drug

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

  • JNJ-87189401Biological

    JNJ-87189401 will be administered.

Study groups in NCT07164443
Study groupRoleWhat they receive
Part 1: Pasritamig+Best Supportive Care (BSC)ExperimentalParticipants 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.
Receives: Biological: Pasritamig; Drug: Best Supportive Care (BSC)
Part 1: Placebo+BSCPlacebo comparatorParticipants 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.
Receives: Other: Placebo; Drug: Best Supportive Care (BSC)
Part 2: Pasritamig+BSCExperimentalParticipants 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.
Receives: Biological: Pasritamig; Drug: Best Supportive Care (BSC)
Part 2: Pasritamig+JNJ-87189401+BSCExperimentalParticipants 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.
Receives: Biological: Pasritamig; Drug: Best Supportive Care (BSC); Biological: JNJ-87189401
Part 2: Placebo +BSCPlacebo comparatorParticipants 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.
Receives: Other: Placebo; Drug: Best Supportive Care (BSC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: Up to 2 years and 8 months

Secondary outcomes (9)

  1. Radiographic Progression-free Survival (rPFS)

    rPFS assessed by investigator defined as the time from the date of randomization until the date of radiographic disease progression (based on response evaluation criteria in solid tumors [RECIST] version (v) 1.1 and prostate cancer working group 3 [PCWG3] criteria) or death, whichever comes first.

    Measured: Up to 2 years and 8 months

  2. Time to Symptomatic Progression

    Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): (a) the use of external beam radiation therapy to relieve cancer-related symptoms; (b) the need for tumor-related orthopedic surgical intervention; (c) other cancer-related procedures; (d) cancer-related morbid events; (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.

    Measured: Up to 2 years and 8 months

  3. Time to Skeletal-Related Event

    Time to skeletal-related event is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): (a) the use of external beam radiation for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; (c) the occurrence of new bone fractures (cancer-related); (d) the occurrence of tumor-related spinal cord compression.

    Measured: Up to 2 years and 8 months

  4. Progression-Free Survival (PFS)

    PFS is defined as the date of randomization to the date of first evidence of radiographic progression, clinical progression, or death from any cause, whichever occurs first.

    Measured: Up to 2 years and 8 months

  5. Time to Prostate Specific Antigen (PSA) Progression

    Time to PSA progression, defined as the time from randomization to the first date of documented PSA progression per PCWG3 criteria. PSA progression is defined as: after a decline from baseline, PSA increases >= 25 percentage (%) and >= 2 nanograms per milliliter (ng/mL) above the nadir, confirmed by a second value >= 3 weeks later (that is, a confirmed rising trend), or If there is no decline from baseline, PSA increases >= 25 % and >= 2 ng/mL from baseline after 12 weeks.

    Measured: Up to 2 years and 8 months

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

    TTPP is defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression is defined as an increase of at least 2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations >= 3 weeks apart. BPI-SF is an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score range from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine".

    Measured: Up to 2 years and 8 months

  7. 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 to deterioration is defined as the time from randomization to the date of the first observation of deterioration in Fatigue. Deterioration in Fatigue is defined as an increase of 10 points on the EORTC QLQ-C30 FA scale observed at 2 consecutive evaluations >= 3 weeks apart. The EORTC QLQ-C30 is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent". Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Higher scores indicate worse symptoms or problems.

    Measured: Up to 2 years and 8 months

  8. Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 2 years and 8 months

  9. Number of Participants with Abnormalities in Clinical Laboratory Assessments

    Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.

    Measured: Up to 2 years and 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start2 Sep 2025
  3. Primary completion18 Aug 2028 (estimated)
  4. Study completion18 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,203 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07164443
Sponsor's protocol ID
78278343PCR3001
Other IDs
2025-520927-26-00, 2025
Acronym
KLK2-comPAS
Status last verified
Nov 2026
First submitted
4 Sep 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pasritamig and JNJ-87189401 in people with Metastatic Castration-resistant Prostatic Neoplasms, run by Janssen Research & Development, LLC at 176 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, China, Japan, France, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 2 years and 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07164443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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