A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

Clinicaltrials.gov ID: NCT06095089
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 130

Conditions

Advanced Prostate Cancer

Drugs

JNJ-78278343, JNJ-87189401

Summary

The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.

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) as defined by Prostate Cancer Working Group 3 (PCWG3): Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
* Measurable or evaluable disease per PCWG3 criteria; all participants must have a serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at time of screening
* Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

Study Plan

Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

EXPERIMENTAL

Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Participants will receive the combination treatment at the RP2R in Part 2 (dose expansion).

  • DRUG:

    JNJ-78278343

    Description:

    JNJ-78278343 will be administered.
  • DRUG:

    JNJ-87189401

    Description:

    JNJ-87189401 will be administered.

Outcome Measures

Primary Outcome Measures

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

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

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

Time Frame: 3 years 7 months

Secondary Outcome Measures

Part 2: Serum Concentration of JNJ-87189401

Time Frame: Up to 3 years 7 months

Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

Time Frame: Up to 3 years 7 months

Objective Response Rate (ORR)

Time Frame: Up to 3 years 7 months

Prostate Specific Antigen (PSA) Response Rate

Time Frame: Up to 3 years 7 months

Duration of Response (DOR)

Time Frame: Up to 3 years 7 months

Timeline

  • Last Updated
    October 21, 2024
  • Start Date
    October 23, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    June 21, 2027

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