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ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
NCT04662580 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Prednisone
- DRUG Abiraterone acetate
- DRUG ARX517
Study Locations (12)
California
- UC San Diego Moores Cancer Center — La Jolla
- University of California, Los Angeles School of Medicine — Los Angeles
- UCSF Medical Center at Mission Bay — San Francisco
Georgia
- Winship Cancer Institute of Emory University — Atlanta
Indiana
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis
Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor
Missouri
- Washington University St. Louis School Medicine Siteman Cancer Center — St Louis
Nebraska
- GU Research Network — Omaha
New York
- Weill Cornell Medical College — New York
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04662580
The ClinicalTrials.gov registry entry for NCT04662580 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 183 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 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 4 interventions — of which Apalutamide 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: NCT04662580 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Georgia, Indiana. 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 NCT04662580 about?
NCT04662580 is a clinical study titled "ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer". This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
What is the current status of trial NCT04662580?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 183 participants. The study started on 2021-05-03. Estimated completion is 2026-12-31.
What conditions does trial NCT04662580 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04662580?
The interventions under investigation include: Apalutamide (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG), ARX517 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04662580?
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 NCT04662580 being conducted?
This trial has 12 study locations across California, Georgia, Indiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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