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NCT04644770 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
A Phase 1 study of Prostatic Neoplasms and Adenocarcinoma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 11
- Study locations
NCT04644770: Active Phase 1 study of Prostatic Neoplasms and Adenocarcinoma, sponsored by Janssen Research & Development.
NCT04644770 is a Phase 1 study of Prostatic Neoplasms and Adenocarcinoma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 144 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (72% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04644770, a Phase 1 study of Prostatic Neoplasms and Adenocarcinoma, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.
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.
Conditions Studied
Interventions
- DRUG JNJ-78278343
- RADIATION Stereotactic body radiation therapy
- DRUG JNJ-69086420
Study Locations (11)
Louisiana
- East Jefferson General Hospital - Metairie
- Tulane University Hospital & Clinics - New Orleans
Arizona
- Mayo Clinic Arizona - Phoenix
California
- City of Hope - Duarte
Florida
- Mayo Clinic in Florida - Jacksonville
Illinois
- University of Chicago - Chicago
Minnesota
- Mayo Clinic Rochester - Rochester
Nebraska
- XCancer Omaha / Urology Cancer Center - Omaha
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2027-01-15 |
| Phase | Phase 1 |
What the registry record for NCT04644770 still lists
NCT04644770 is an interventional study that assigns participants to a tested intervention. The registered 144 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 (72% lower).
The record links to 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which JNJ-78278343 is the first listed.
NCT04644770 lists 11 locations in 10 states (Louisiana, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT04644770 about?
NCT04644770 is a clinical study titled "A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer". The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combina...
What is the current status of trial NCT04644770?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2020-11-12. Estimated completion is 2027-01-15.
What conditions does trial NCT04644770 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Adenocarcinoma.
What interventions are being tested in trial NCT04644770?
The interventions under investigation include: JNJ-78278343 (DRUG), Stereotactic body radiation therapy (RADIATION), JNJ-69086420 (DRUG).
Who is sponsoring clinical trial NCT04644770?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04644770 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04644770's enrollment target sits among peer trials
144 33rd of 65 higher than 33 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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