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NCT06095089 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
A Phase 1 study of Advanced Prostate Cancer, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 6
- Study locations
NCT06095089: Recruiting Phase 1 study of Advanced Prostate Cancer, sponsored by Janssen Research & Development.
NCT06095089 is a Phase 1 study of Advanced Prostate Cancer that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 250 participants, above the 92-participant average among 6 other Advanced Prostate Cancer trials with a reported enrollment target (172% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06095089, a Phase 1 study of Advanced Prostate Cancer, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Conditions Studied
Interventions
- DRUG JNJ-78278343
- DRUG JNJ-87189401
Study Locations (6)
Other
- Centre Leon Berard - Lyon
- Institut Gustave Roussy - Villejuif
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
New York
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center - New York
Tennessee
- Tennessee Oncology - Nashville
Texas
- South Texas Accelerated Research Therapeutics, LLC (START) - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2028-06-28 |
| Phase | Phase 1 |
What NCT06095089 shows while recruiting
NCT06095089 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 6 other Advanced Prostate Cancer trials with a reported enrollment target (172% higher).
The record links to 1 condition, with Advanced Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which JNJ-78278343 is the first listed.
NCT06095089 lists 6 locations in 5 states (Other, Colorado, New York).
Frequently Asked Questions
What is clinical trial NCT06095089 about?
NCT06095089 is a clinical study titled "A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer". 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.
What is the current status of trial NCT06095089?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2023-11-01. Estimated completion is 2028-06-28.
What conditions does trial NCT06095089 study?
This clinical trial studies the following conditions: Advanced Prostate Cancer.
What interventions are being tested in trial NCT06095089?
The interventions under investigation include: JNJ-78278343 (DRUG), JNJ-87189401 (DRUG).
Who is sponsoring clinical trial NCT06095089?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06095089 being conducted?
This trial has 6 study locations across Colorado, New York, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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