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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

Status: Recruiting
Location: See all (163) locations...
Intervention Type: Drug, Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
California
University of California at San Diego
RECRUITING
La Jolla
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Aurora
University of Colorado Cancer Center
RECRUITING
Aurora
Colorado Clinical Research
RECRUITING
Lakewood
Connecticut
Hartford Hospital
RECRUITING
Hartford
Washington, D.c.
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Bay Pines VA Healthcare System
RECRUITING
Bay Pines
Florida Cancer Specialists & Research Institute
RECRUITING
Fort Myers
Moffitt Cancer Center
RECRUITING
Tampa
Louisiana
East Jefferson General Hospital
RECRUITING
Metairie
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Henry Ford Cancer Detroit
RECRUITING
Detroit
Minnesota
University Of Minnesota Medical Center
RECRUITING
Minneapolis
Nebraska
XCancer Omaha / Urology Cancer Center
RECRUITING
Omaha
New York
NYU Langone Hospitals
RECRUITING
Brooklyn
NYU Langone Hospital Long Island
RECRUITING
Mineola
Columbia University Medical Center
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New York
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
RECRUITING
New York
Ohio
University of Cincinnati
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Cincinnati
University Hospital of Cleveland
RECRUITING
Cleveland
Oregon
Compass Oncology
RECRUITING
Portland
Oregon Urology Institute
RECRUITING
Springfield
Pennsylvania
MidLantic Urology
RECRUITING
Bala-cynwyd
Keystone Urology Specialists
RECRUITING
Lancaster
Penn Medicine Abramson Cancer Center
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Philadelphia
UPMC Cancer Centers
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Pittsburgh
South Carolina
Ralph H Johnson Veterans Hospital
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Charleston
Gibbs Cancer Center and Research Institute Pelham
RECRUITING
Greer
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Gibbs Cancer Center
RECRUITING
Spartanburg
Tennessee
Tennessee Oncology - Chattanooga
RECRUITING
Chattanooga
Tennessee Oncology Nashville
RECRUITING
Nashville
Texas
Urology Clinics of North Texas
RECRUITING
Dallas
UT Southwestern Medical Center
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Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Michael E DeBakey VA Medical Center
RECRUITING
Houston
Texas Oncology West Texas
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Wichita Falls
Utah
Utah Cancer Specialists
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists
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Fairfax
Virginia Oncology Associates
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Norfolk
Blue Ridge Cancer Care
RECRUITING
Roanoke
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
University of Washington
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Seattle
VA Puget Sound Healthcare System
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Seattle
Other Locations
Australia
Warringal Private Hospital
RECRUITING
Heidelberg
ICON Cancer Care
RECRUITING
Kurralta Park
Peter MacCallum Cancer Centre
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Melbourne
Fiona Stanley Hospital
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Murdoch
Princess Alexandra Hospital
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Woolloongabba
Belgium
AZ Sint-Jan
RECRUITING
Bruges
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
AZ Maria Middelares
RECRUITING
Ghent
Ghent University Hospital
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Ghent
Az Groeninge
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Kortrijk
Chu Helora Hospital La Louviere Site Jolimont
RECRUITING
La Louvière
CHC MontLegia
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Liège
Clinique Saint Pierre
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Ottignies
ZAS Augustinus
RECRUITING
Wilrijk
Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
RECRUITING
Florianópolis
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
RECRUITING
Joinville
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Associacao Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
São Paulo
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
Lakeridge Health
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Oshawa
CHU de Quebec Universite Laval
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Québec
Princess Margaret Hospital
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Toronto
Sunnybrook Health Sciences Center
RECRUITING
Toronto
BC Cancer Vancouver
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Vancouver
China
Peking University First Hospital
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Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
West China Hospital of Sichuan University
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Chengdu
Chongqing University Cancer Hospital
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Chongqing
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Nantong Tumor Hospital
RECRUITING
Nantong
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
The Second Hospital Of Tianjin Medical University
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Zhongnan Hospital Wu Han University
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
France
Institut Bergonie
RECRUITING
Bordeaux
CHRU Brest - Hopital Morvan
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Brest
Centre Georges Francois Leclerc
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Dijon
Centre Oscar Lambret
RECRUITING
Lille
Centre Leon Berard
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Lyon
Hopital Saint Joseph
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Paris
CHU Lyon Sud
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Pierre-bénite
I.C.O. Rene Gauducheau
RECRUITING
Saint-herblain
Hopitaux universitaires de Strasbourg
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Strasbourg
Institut de Cancerologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Germany
Staedtisches Klinikum Braunschweig
RECRUITING
Braunschweig
Urologicum Duisburg
RECRUITING
Duisburg
Universitaetsklinikum Duesseldorf
RECRUITING
Düsseldorf
Universitaetsklinikum Essen
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Essen
Krankenhaus NorthWest
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Frankfurt Am Main
Martini-Klinik am UKE GmbH
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Hamburg
Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen
RECRUITING
Heidelberg
Klinikum rechts der Isar der TU Muenchen
RECRUITING
München
Universitaetsklinikum Muenster
RECRUITING
Münster
Klinikum Nuernberg Nord
RECRUITING
Nuremberg
Studienpraxis Urologie Nurtingen
RECRUITING
Nürtingen
Italy
Ospedali Riuniti Foggia
RECRUITING
Foggia
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
IOV IRCCS Padova
RECRUITING
Padova
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
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Palermo
Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō City
Kyushu University Hospital
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Fukuoka
Saitama Medical University International Medical Center
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Hidaka
Kanazawa University Hospital
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Kanazawa
Kobe University Hospital
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Kobe
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
National Hospital Organization Tokyo Medical Center
RECRUITING
Meguro Ku
Toho University Sakura Medical Center
RECRUITING
Sakura
Yokohama City University Hospital
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Yokohama
Yokohama City University Medical Center
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Yokohama
Yokosuka Kyosai Hospital
RECRUITING
Yokosuka
Netherlands
Reinier de Graaf Gasthuis
RECRUITING
Delft
Martini Ziekenhuis
RECRUITING
Groningen
Tergooi
RECRUITING
Hilversum
Spaarne Gasthuis
RECRUITING
Hoofddorp
Maastricht UMC
RECRUITING
Maastricht
Canisius-Wilhelmina ZH
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Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Isala Kliniek
RECRUITING
Zwolle
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Bialystok
IN VIVO Sp. z o.o
RECRUITING
Bydgoszcz
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
RECRUITING
Koszalin
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
RECRUITING
Warsaw
Puerto Rico
Pan American Center for Oncology Trials LLC
RECRUITING
Rio Piedras
Puerto Rico Medical Research Center
RECRUITING
San Juan
Republic of Korea
Chungnam National University Hospital
RECRUITING
Daejeon
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Hwasungun
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de Jerez de La Frontera
RECRUITING
Jerez De La Frontera
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Hosp Virgen de La Victoria
RECRUITING
Málaga
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
Tungs' Taichung MetroHarbor Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
University College London Hospitals
RECRUITING
London
The Christie NHS Foundation Trust Christie Hospital
RECRUITING
Manchester
Royal Marsden Hospital (Sutton)
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 663
Treatments
Experimental: Pasritamig Plus Best Supportive Care (BSC)
Participants 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_comparator: Placebo Plus BSC
Participants 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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov