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NCT02625857 · ClinicalTrials.gov registry record · Phase 1
Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02625857: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02625857 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02625857, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC).
Primary Outcome
Percentage of Participants who Experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (\>=) 33 percent (%).
Interventions
- BIOLOGICAL JNJ-64041809 (Cohort 1A and 1B)
- BIOLOGICAL JNJ-64041809 (Cohort 2A and 2B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-12-10 |
| Est. Completion | 2018-07-03 |
| Phase | Phase 1 |
What the finished NCT02625857 record still lists
NCT02625857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which JNJ-64041809 (Cohort 1A and 1B) is the first listed.
NCT02625857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02625857 about?
NCT02625857 is a clinical study titled "Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer". The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intraveno...
What is the current status of trial NCT02625857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2015-12-10. Estimated completion is 2018-07-03.
What interventions are being tested in trial NCT02625857?
The interventions under investigation include: JNJ-64041809 (Cohort 1A and 1B) (BIOLOGICAL), JNJ-64041809 (Cohort 2A and 2B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02625857?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02625857's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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