NCT05503797

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Fore Biotherapeutics · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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

• Cancer Harboring BRAF Alterations
• HGG
• LGG
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Plixorafenib	Oral tablets

Timeline

• Start date: 2023-02-21
• Primary completion: 2026-06-27
• Completion: 2026-12-28
• First posted: 2022-08-17
• Last updated: 2026-04-03

Locations

67 sites across 11 countries: United States, Australia, Canada, France, Germany, Italy, Norway, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study