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NCT05503797 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
A Phase 2 study of Solid Tumors and HGG, sponsored by Fore Biotherapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
- 20
- Study locations
NCT05503797: Recruiting Phase 2 study of Solid Tumors and HGG, sponsored by Fore Biotherapeutics.
NCT05503797 is a Phase 2 study of Solid Tumors and HGG that is actively recruiting participants, run by Fore Biotherapeutics. The registered enrollment target is 254 participants, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05503797, a Phase 2 study of Solid Tumors and HGG, is actively recruiting participants, sponsored by Fore Biotherapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).
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 |
What NCT05503797 shows while recruiting
NCT05503797 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (10% lower).
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.
NCT05503797 names 20 study sites across 12 states, led by California, Massachusetts, Ohio.
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.
What interventions are being tested in trial NCT05503797?
The interventions under investigation include: Plixorafenib (DRUG).
Who is sponsoring clinical trial NCT05503797?
This trial is sponsored by Fore Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05503797's enrollment target sits among peer trials
254 23rd of 125 higher than 103 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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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