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

NCT06095089 · Janssen Research & Development, LLC
In plain English

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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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 * Part 1, Part 2A and Part 2B: 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 design
Enrollment target: 250 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-01
Estimated completion: 2028-06-28
Last updated: 2026-02-17
Interventions
Drug: JNJ-78278343Drug: JNJ-87189401
Primary outcomes
  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (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 (Up to 3 years 7 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (6)
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterRecruiting
New York, New York, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC (START)Recruiting
San Antonio, Texas, United States
Centre Leon BerardRecruiting
Lyon, France
Institut Gustave RoussyRecruiting
Villejuif, France
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer · TrialPath