A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Last updated: May 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Cetrelimab

JNJ-78278343

Enzalutamide

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 JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1 A-G (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 (apalutamide, enzalutamide, darolutamide, abiraterone acetate +prednisone [AAP]): mCRPC: Histologically confirmed adenocarcinoma of the prostate asdefined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) withnon-castrate levels of testosterone (greater than [>] 150 ng/ deciliter [dL]) and aminimum PSA of 2 ng/milliliter [mL]; (b) Metastatic disease documented by greaterthan equal to (>=) 1 bone lesion(s) on technetium-99m (99m^Tc) bone scan. Nodefinitive evidence of metastatic visceral disease

  • Measurable or evaluable disease

  • (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 and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie,abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d)Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy

  • 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) ofJNJ-78278343, 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)

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

Study Design

Total Participants: 213
Treatment Group(s): 8
Primary Treatment: Cetrelimab
Phase: 1
Study Start date:
April 26, 2023
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037
    Australia

    Active - Recruiting

  • Macquarie University

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Active - Recruiting

  • 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

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Start Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • 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

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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