A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Last updated: May 7, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Lutetium Lu-177 vipivotide tetraxetan

Pasritamig

Cetrelimab

Clinical Study ID

NCT05818683
CR109321
2022-503132-14
78278343PCR1003
2022-503132-14-00
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel,docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmedadenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide,abiraterone acetate + prednisone [AAP], lutetium Lu-177 vipivotide tetraxetan,JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate asdefined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greaterthan (>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)

  • Measurable or evaluable disease, except for Part 2H

  • (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgenreceptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide,enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K & 2K (JNJ-101556143)- Priortreatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide,darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Priortreatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide,enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Priortreatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may havereceived up to 6 cycles of docetaxel. The last dose of docetaxel must beadministered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I & 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant mustnot have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT)for mCRPC

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Adequate organ functions

Exclusion

Exclusion Criteria:

  • Active autoimmune disease within the 12 months prior to signing consent thatrequires systemic immunosuppressive medications

  • Toxicity related to prior anticancer therapy that has not returned to Grade lessthan or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2peripheral neuropathy)

  • Solid organ or bone marrow transplantation

  • Known allergies, or intolerance to any of the components (example, excipients) ofpasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1Cand 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E),darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotidetetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K & 2K)

  • Significant infections or serious lung, heart or other medical conditions

Study Design

Total Participants: 300
Treatment Group(s): 11
Primary Treatment: Lutetium Lu-177 vipivotide tetraxetan
Phase: 1
Study Start date:
April 26, 2023
Estimated Completion Date:
May 23, 2028

Connect with a study center

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037
    Australia

    Active - Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park 8348005, 5037
    Australia

    Site Not Available

  • Macquarie University

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, 3000
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, 4102
    Australia

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Hosp Univ Vall D Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona 3128760, 8035
    Spain

    Site Not Available

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • Start Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Start Midwest

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School Of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Perlmutter Cancer Center at NYU Langone Brooklyn

    Brooklyn, New York 11223
    United States

    Active - Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Brooklyn

    Brooklyn 5110302, New York 5128638 11223
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola 5127134, New York 5128638 11501
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

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