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NCT07082920 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
A Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 6
- Study locations
NCT07082920: Recruiting Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
NCT07082920 is a Phase 1 study of Prostatic Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 140 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07082920, a Phase 1 study of Prostatic Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death rela
Conditions Studied
Interventions
- DRUG JNJ-78278343
- DRUG JNJ-95298177
Study Locations (6)
Other
- The Christie Nhs Foundation Trust - Manchester
- Royal Marsden Hospital (Sutton) - Sutton
Florida
- Florida Cancer Specialists - Sarasota
New York
- Columbia University Medical Center - New York
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT07082920 shows while recruiting
NCT07082920 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which JNJ-78278343 is the first listed.
NCT07082920 lists 6 locations in 5 states (Other, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT07082920 about?
NCT07082920 is a clinical study titled "A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer". The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistan...
What is the current status of trial NCT07082920?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2025-07-07. Estimated completion is 2027-03-01.
What conditions does trial NCT07082920 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT07082920?
The interventions under investigation include: JNJ-78278343 (DRUG), JNJ-95298177 (DRUG).
Who is sponsoring clinical trial NCT07082920?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07082920 being conducted?
This trial has 6 study locations across Florida, New York, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07082920's enrollment target sits among peer trials
140 34th of 65 higher than 32 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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