NCT05503797

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

Recruiting now Phase 2 Last updated 3 April 2026

What this trial tests

Phase 2 trial testing Plixorafenib in Cancer Harboring BRAF Alterations in 254 participants. Currently enrolling.

Timeline

21 February 2023

Primary endpoint
27 June 2026

28 December 2026

Quick facts

Lead sponsor	Fore Biotherapeutics
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	254
Start date	21 February 2023
Primary completion	27 June 2026
Estimated completion	28 December 2026
Sites	67 locations across France, Italy, Sweden, United Kingdom, Germany, Norway, South Korea, Canada

Drugs / interventions tested

• Plixorafenib — full drug profile →

Conditions studied

• Cancer Harboring BRAF Alterations — all drugs for Cancer Harboring BRAF Alterations →
• HGG — all drugs for HGG →
• LGG — all drugs for LGG →
• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Fore Biotherapeutics — full company profile →

Who can join

10 and older, any sex, with Cancer Harboring BRAF Alterations or HGG. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. BRAF - a tumour-agnostic drug target with lineage-specific dependencies.
   Hanrahan AJ, Chen Z, Rosen N, Solit DB. · · 2024 · cited 92× · PMID 38278874 · DOI 10.1038/s41571-023-00852-0
2. Integrated molecular and clinical analysis of BRAF-mutant glioma in adults.
   Schreck KC, Langat P, Bhave VM, Li T, et al · · 2023 · cited 23× · PMID 36854806 · DOI 10.1038/s41698-023-00359-y
3. State of the Art in Low-Grade Glioma Management: Insights From Isocitrate Dehydrogenase and Beyond.
   Schaff LR, Ioannou M, Geurts M, van den Bent MJ, et al · · 2024 · cited 13× · PMID 38723228 · DOI 10.1200/edbk_431450
4. Novel RAF-directed approaches to overcome current clinical limits and block the RAS/RAF node.
   Scardaci R, Berlinska E, Scaparone P, Vietti Michelina S, et al · · 2024 · cited 9× · PMID 38362705 · DOI 10.1002/1878-0261.13605
5. Precision Medicine for Pediatric Glioma and NF1-Associated Tumors: The Role of Small Molecule Inhibitors.
   Renzi S, Bennett J, Thacker N, Cacciotti C. · · 2025 · cited 1× · PMID 40422539 · DOI 10.3390/curroncol32050280
6. Targeted therapies in adolescent and young adult patients with central nervous system tumors.
   Mullins A, Bennett J, Yeo KK, Lim-Fat MJ. · · 2026 · PMID 42059000 · DOI 10.1093/noajnl/vdaf043
7. RAS/MAPK inhibition in pediatric gliomas.
   Alshammari AJM, Hargrave D, Das A. · · 2026 · PMID 42058999 · DOI 10.1093/noajnl/vdaf007
8. Mechanisms and pathways of ROS and autophagy in thyroid cancer.
   Wu J, Chen Z, Duan J, Zhang G. · · 2025 · PMID 41215686 · DOI 10.1080/20565623.2025.2580889