A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
KLK2-comPAS
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
2 other identifiers
interventional
663
17 countries
163
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Typical duration for phase_3
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2025
CompletedFirst Submitted
Initial submission to the registry
September 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
April 13, 2026
April 1, 2026
2.7 years
September 4, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from randomization to date of death due to any cause.
Up to 2 years and 8 months
Secondary Outcomes (9)
Radiographic Progression-free Survival (rPFS)
Up to 2 years and 8 months
Time to Symptomatic Progression
Up to 2 years and 8 months
Time to Skeletal-Related Event
Up to 2 years and 8 months
Progression-Free Survival (PFS)
Up to 2 years and 8 months
Time to Prostate Specific Antigen (PSA) Progression
Up to 2 years and 8 months
- +4 more secondary outcomes
Study Arms (2)
Pasritamig Plus Best Supportive Care (BSC)
EXPERIMENTALParticipants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15. From C2D1 onwards participants will receive pasritamig target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. 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 Plus BSC
PLACEBO COMPARATORParticipants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. 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 at the discretion of the physician.
Interventions
BSC will be administered at the discretion of the treating physician.
Pasritamig will be administrated through IV infusion.
Eligibility Criteria
You may qualify if:
- 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:
- 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. 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:
- 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): 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (163)
University of California at San Diego
La Jolla, California, 92093, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Detroit
Detroit, Michigan, 48202, United States
University Of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130, United States
NYU Langone Hospitals
Brooklyn, New York, 11220, United States
NYU Langone Hospital Long Island
Mineola, New York, 11501, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Compass Oncology
Portland, Oregon, 97227, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17601, United States
Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Ralph H Johnson Veterans Hospital
Charleston, South Carolina, 29401, United States
Gibbs Cancer Center and Research Institute Pelham
Greer, South Carolina, 29650, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Gibbs Cancer Center
Spartanburg, South Carolina, 29303, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology Nashville
Nashville, Tennessee, 37203, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
Texas Oncology West Texas
Wichita Falls, Texas, 76310, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Washington
Seattle, Washington, 98195, United States
Warringal Private Hospital
Heidelberg, 3084, Australia
ICON Cancer Care
Kurralta Park, 5037, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
AZ Sint-Jan
Bruges, 8000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, 7100, Belgium
CHC MontLegia
Liège, 4000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
ZAS Augustinus
Wilrijk, 2610, Belgium
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034 000, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201 260, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035 901, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Lakeridge Health
Oshawa, Ontario, L1G2B9, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2C1, Canada
CHU de Quebec Universite Laval
Québec, Quebec, G1J 1Z4, Canada
Peking University First Hospital
Beijing, 100034, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Nantong Tumor Hospital
Nantong, 226300, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Zhongnan Hospital Wu Han University
Wuhan, 430071, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Institut Bergonie
Bordeaux, 33000, France
CHRU Brest - Hopital Morvan
Brest, 29200, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Centre Oscar Lambret
Lille, 59000, France
Centre Leon Berard
Lyon, 69008, France
Hopital Saint Joseph
Paris, 75014, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
I.C.O. Rene Gauducheau
Saint-Herblain, 44805, France
Hopitaux universitaires de Strasbourg
Strasbourg, 672098, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Gustave Roussy
Villejuif, 94800, France
Staedtisches Klinikum Braunschweig
Braunschweig, 38126 DE, Germany
Urologicum Duisburg
Duisburg, 47169, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Krankenhaus NorthWest
Frankfurt am Main, 60488, Germany
Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen
Heidelberg, 69120, Germany
Klinikum rechts der Isar der TU Muenchen
München, 81675, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Klinikum Nuernberg Nord
Nuremberg, 90419, Germany
Studienpraxis Urologie Nurtingen
Nürtingen, 72622, Germany
Ospedali Riuniti Foggia
Foggia, 71122, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
IOV IRCCS Padova
Padova, 35128, Italy
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
Palermo, 90127, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519, Japan
Kyushu University Hospital
Fukuoka, 812 8582, Japan
Saitama Medical University International Medical Center
Hidaka, 350 1298, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Kobe University Hospital
Kobe, 650 0017, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
National Hospital Organization Tokyo Medical Center
Meguro Ku, 152 8902, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Yokohama City University Hospital
Yokohama, 236 0004, Japan
Yokosuka Kyosai Hospital
Yokosuka, 238 8558, Japan
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Martini Ziekenhuis
Groningen, 9728NT, Netherlands
Tergooi
Hilversum, 1212 VG, Netherlands
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
Maastricht UMC
Maastricht, 6229 HX, Netherlands
Canisius-Wilhelmina ZH
Nijmegen, 6532 SZ, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Isala Kliniek
Zwolle, 8025 AB, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
Koszalin, 75 581, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02 781, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, 04 073, Poland
Pan American Center for Oncology Trials LLC
Rio Piedras, 00935, Puerto Rico
Puerto Rico Medical Research Center
San Juan, 00917, Puerto Rico
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasungun, 58128, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
University College London Hospitals
London, WC1E 6BT, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT, United Kingdom
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2025
First Posted
September 10, 2025
Study Start
September 2, 2025
Primary Completion (Estimated)
May 30, 2028
Study Completion (Estimated)
May 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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