A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT ID: NCT07164443
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
663 participants
INTERVENTIONAL
2025-09-02
2028-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 (Cycle 1 duration is 8 weeks). From C2D1 onwards ( Cycle Duration is 6 week), participants will receive pasritamig target dose IV every 6 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.
Pasritamig
Pasritamig will be administrated through IV infusion.
Best Supportive Care (BSC)
BSC will be administered as per physician.
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 and 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.
Placebo
Placebo will be administrated through IV infusion.
Best Supportive Care (BSC)
BSC will be administered as per physician.
Interventions
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Pasritamig
Pasritamig will be administrated through IV infusion.
Placebo
Placebo will be administrated through IV infusion.
Best Supportive Care (BSC)
BSC will be administered as per physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening
* 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:
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: 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:
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): 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 \* ULN D) Absolute neutrophil count (ANC) \>= 1.0 \*10\^9/per liter (L) E) Hemoglobin \>= 8.0 grams per deciliter (g/dL) F) Platelet count \>= 75 \* 109/L
Exclusion Criteria
* Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
* 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States
NYU Langone Hospitals
Brooklyn, New York, United States
NYU Langone Hospital Long Island
Mineola, New York, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Compass Oncology
Portland, Oregon, United States
Oregon Urology Institute
Springfield, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center and Research Institute Pelham
Greer, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Gibbs Cancer Center
Spartanburg, South Carolina, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology West Texas
Wichita Falls, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Warringal Private Hospital
Heidelberg, , Australia
ICON Cancer Care
Kurralta Park, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
AZ Sint-Jan
Bruges, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, , Belgium
CHC MontLegia
Liège, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, , Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
BC Cancer Vancouver
Vancouver, British Columbia, Canada
CHU de Quebec Universite Laval
Québec, Quebec, Canada
West China Hospital of Sichuan University
Chengdu, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Urologicum Duisburg
Duisburg, , Germany
Krankenhaus NorthWest
Frankfurt am Main, , Germany
Martini-Klinik am UKE GmbH
Hamburg, , Germany
Istituto Clinico Humanitas
Rozzano, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Kobe University Hospital
Kobe, , Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, , Japan
National Hospital Organization Tokyo Medical Center
Meguro Ku, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Yokosuka Kyosai Hospital
Yokosuka, , Japan
Reinier de Graaf Gasthuis
Delft, , Netherlands
Tergooi
Hilversum, , Netherlands
IN VIVO Sp. z o.o
Bydgoszcz, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Puerto Rico Medical Research Center
Hato Rey, , Puerto Rico
Pan American Center for Oncology Trials LLC
Rio Piedras, , Puerto Rico
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
University College London Hospitals
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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78278343PCR3001
Identifier Type: OTHER
Identifier Source: secondary_id
2025-520927-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
78278343PCR3001
Identifier Type: -
Identifier Source: org_study_id