Status:
RECRUITING
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 27 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06095089
Start Date
November 1 2023
End Date
October 27 2027
Last Update
December 5 2025
Active Locations (5)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032
3
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States, 78229
4
Centre Leon Berard
Lyon, France, 69008