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A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
NCT05503797 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.
Conditions Studied
Interventions
- DRUG Plixorafenib
Study Locations (20)
California
- Precision NextGen Oncology & Research Center — Beverly Hills
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- University of California Los Angeles Rheumatology — Westwood, Los Angeles
Massachusetts
- Tufts Medical Center — Boston
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Ohio
- Nationwide Children's Hospital — Columbus
- Taylor Cancer Research Center — Maumee
- Toledo Clinic Cancer Center — Toledo
Maryland
- The John Hopkins Hospital — Baltimore
- Maryland Oncology Hematology- Columbia — Rockville
New York
- Columbia University Irving Medical Center — New York
- Memorial Sloan Kettering Cancer Center — New York
Connecticut
- Norwalk Hospital — Norwalk
Florida
- University of Miami Hospital and Clinics — Miami
Minnesota
- St. Luke's Hospital — Duluth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2026-12-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05503797
The ClinicalTrials.gov registry entry for NCT05503797 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fore Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which Plixorafenib 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: NCT05503797 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Ohio. 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 NCT05503797 about?
NCT05503797 is a clinical study titled "A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations". The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutate...
What is the current status of trial NCT05503797?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2023-02-21. Estimated completion is 2026-12-28.
What conditions does trial NCT05503797 study?
This clinical trial studies the following conditions: Solid Tumors, HGG, LGG, Cancer Harboring BRAF Alterations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05503797?
The interventions under investigation include: Plixorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05503797?
This trial is sponsored by Fore Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05503797 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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