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

Clinicaltrials.gov ID: NCT05818683
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 200

Conditions

Metastatic Castration-resistant Prostate Neoplasms

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

3 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

Eligibility Criteria

Inclusion Criteria:

* Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
* Measurable or evaluable disease.
* (a) Part 1A: JNJ-78278343 + cetrelimab - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel). (b) Part 1C: JNJ-78278343 + docetaxel, Part 1D: JNJ-78278343 + apalutamide, Part 1E: JNJ-78278343 + enzalutamide, Part 1F: JNJ-78278343 + darolutamide, and Part 1G: JNJ-78278343 + abiraterone acetate + prednisone - Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate,). (C) Part 1B: JNJ-78278343 + cabazitaxel - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel.
* 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), docetaxel (Part 1C), apalutamide (Part 1D), enzalutamide (Part 1E), darolutamide (Part 1F), or abiraterone acetate + prednisone (AAP) (Part 1G)
* 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

Timeline

  • Last Updated
    October 24, 2024
  • Start Date
    April 19, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    September 1, 2027

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