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

Description

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.

Conditions

Advanced Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

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

Condition
Advanced Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center, New York, New York, United States, 10032

San Antonio

South Texas Accelerated Research Therapeutics, LLC (START), San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-06-21