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

Clinicaltrials.gov ID: NCT05818683
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 185

Conditions

Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer

Drugs

JNJ-78278343, Cetrelimab, Cabazitaxel, Docetaxel, Apalutamide, Enzalutamide, Darolutamide, Abiraterone acetate plus prednisone (AAP)

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).

Locations

7 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Eligibility Criteria

Inclusion Criteria:

* Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma 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 as defined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (>) 0.2 ng/mL despite being treated with next generation ARPI (apalutamide, enzalutamide, darolutamide) for between 180 and 365 days (inclusive); (b) Participant may not have progressed radiographically or have PSA progression while receiving androgen deprivation therapy (ADT) and ARPI, as defined by PCWG3
* Measurable or evaluable disease
* (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor 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 Criteria:

* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
* Solid organ or bone marrow transplantation
* Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 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 Plan

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

EXPERIMENTAL

Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

  • DRUG:

    JNJ-78278343

    Description:

    JNJ-78278343 will be administered.
  • DRUG:

    Cetrelimab

    Description:

    Cetrelimab will be administered by intravenous infusion.
  • DRUG:

    Cabazitaxel

    Description:

    Cabazitaxel will be administered by intravenous infusion.
  • DRUG:

    Docetaxel

    Description:

    Docetaxel will be administered by intravenous infusion.
  • DRUG:

    Apalutamide

    Description:

    Apalutamide will be administered orally.
  • DRUG:

    Enzalutamide

    Description:

    Enzalutamide will be administered orally.
  • DRUG:

    Darolutamide

    Description:

    Darolutamide will be administered orally.
  • DRUG:

    Abiraterone acetate plus prednisone (AAP)

    Description:

    Abiraterone acetate plus prednisone (AAP) will be administered orally.

Outcome Measures

Primary Outcome Measures

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Time Frame: Up to 21 days after first dose of combination agent

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

Time Frame: Up to 2 years 11 months

Secondary Outcome Measures

Overall Response Rate (ORR)

Time Frame: Up to 2 years 11 months

Prostate Specific Antigen (PSA) Response Rate

Time Frame: Up to 2 years 11 months

Radiographic Progression-free Survival (rPFS)

Time Frame: Up to 2 years 11 months

Time to Response (TTR)

Time Frame: Up to 2 years 11 months

Duration of Response (DOR)

Time Frame: Up to 2 years 11 months

Part 2H: Composite Progression-Free Survival (PFS)

Time Frame: Up to 2 years 11 months

Timeline

  • Last Updated
    December 5, 2025
  • Start Date
    April 19, 2023
  • Today
    January 5, 2026
  • Completion Date ( Estimated )
    September 1, 2027

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