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NCT06095089 | RECRUITING | Advanced Prostate Cancer

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

Janssen Research & Development, LLC

Brief 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.

Condition or disease

Advanced Prostate Cancer

Intervention/treatment

JNJ-78278343

JNJ-87189401

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2027-06-21
Estimated Study Completion Date : 2027-10-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

Location Details

NCT06095089

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

RECRUITING

United States, New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States, 10032

RECRUITING

United States, Texas

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, United States, 78229

RECRUITING

France,

Center Leon Berard

Lyon, France, 69008

RECRUITING

France,

Gustave Roussy Institute

Villejuif, France, 94800