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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 (May 2026). This Phase 2 trial studies Plixorafenib for cancer harboring braf alterations.

Phase 2RecruitingFore BiotherapeuticsNCT05503797Data as of May 2026

Treatment: PlixorafenibThe 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.

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Extracted eligibility criteria

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

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 →

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