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A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
NCT04644770 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04644770
The ClinicalTrials.gov registry entry for NCT04644770 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04644770 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Louisiana, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04644770?
The interventions under investigation include: JNJ-78278343 (DRUG), Stereotactic body radiation therapy (RADIATION), JNJ-69086420 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04644770?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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