OncoMatch/Clinical Trials/NCT05503797
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Is NCT05503797 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Plixorafenib for cancer harboring braf alterations.
Treatment: Plixorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRAF fusion
Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.
Required: BRAF V600E
Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test
Excluded: RAS activating mutation
Malignancy with co-occurring activating RAS mutation(s) at any time
Excluded: NF1 mutation
Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations
Disease stage
Grade: 1234 (who)
Performance status
WHO 0–1
Demographics
Prior therapy
Must have received: standard therapy — all available
Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.
Must have received: radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy — glioma
Had prior treatment with radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy OR...not considered standard of care may remain eligible
Cannot have received: RAF/BRAF inhibitor active for Class 2 BRAF alterations
Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
Cannot have received: MEK inhibitor
Prior treatment with a MEK inhibitor.
Cannot have received: BRAF inhibitor
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s).
Cannot have received: ERK inhibitor
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s).
Lab requirements
Liver function
Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.
Cardiac function
History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure >160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities.
Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure >160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Precision NextGen Oncology & Research Center · Beverly Hills, California
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- University of California Los Angeles Rheumatology · Westwood, Los Angeles, California
- Norwalk Hospital · Norwalk, Connecticut
- University of Miami Hospital and Clinics · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05503797 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior RAF/BRAF inhibitor active for Class 2 BRAF alterations, MEK inhibitor, BRAF inhibitor disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF fusion is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF V600E is a required biomarker for enrollment.
Are patients with RAS alterations eligible?
No. RAS activating mutation is an exclusion criterion.
Are patients with NF1 alterations eligible?
No. NF1 mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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