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 (Sep 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 BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.
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 at CLIA or CLIA-equivalent laboratory
Required: BRAF v600e
Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test
Required: BRAF v600e
Evidence of BRAF V600E mutation in tumor and/or blood detected by genomic tests
Excluded: RAS activating mutation
Malignancy with co-occurring activating RAS mutation(s) at any time [Subprotocol A exclusion]; Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations [Subprotocols B, C, D exclusion]
Excluded: NF1 alteration
Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations [Subprotocols B, C, D exclusion]
Excluded: AR activating mutation
Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1) [Subprotocol C exclusion]
Excluded: ESR1 activating mutation
Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1) [Subprotocol C exclusion]
Performance status
WHO 0–1
Demographics
Prior therapy
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 [Subprotocol A exclusion]
Cannot have received: MEK inhibitor
Prior treatment with a MEK inhibitor [Subprotocol A exclusion]; Prior treatment with BRAF, ERK, and/or MEK inhibitor(s) [Subprotocols B, C exclusion]
Cannot have received: ERK inhibitor
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s) [Subprotocols B, C exclusion]
Cannot have received: BRAF inhibitor
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s) [Subprotocols B, C exclusion]
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, ERK 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.
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 alteration 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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