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Clinical Trial plixorafenib

A trial targeting tumors with specific BRAF gene alterations that cause uncontrolled cell growth.

About the Trial

The objective of this trial is to determine how effective plixorafenib is for treating tumor types with specific BRAF alterations. The trial will also look at the safety and pharmacokinetics (how the drug is metabolized or processed in the body) of plixorafenib.

In the trial, plixorafenib is taken daily, orally in tablet form.

Some patients will take plixorafenib with another drug called cobicistat, which increases the level of plixorafenib in the blood.


Targeting BRAF alterations as a cancer treatment

What is BRAF and why is it important?

BRAF proteins are large molecules that work with other proteins to relay a signal telling cells that it is time to grow and divide. Changes, or alterations, to the BRAF gene can cause the BRAF protein to keep this signal permanently on, meaning that affected cells may multiply uncontrollably and possibly form a cancerous tumor.

Tell me more about plixorafenib

Plixorafenib (sometimes also called FORE8394 or PLX-8394) inhibits BRAF signaling in such a way that it appears effective (in animal models of cancer, and in human trials) in the treatment of tumors driven by various types of BRAF alterations.

Plixorafenib is specifically designed to block the signaling of the altered protein in cancer cells and may slow the growth of tumors with specific BRAF alterations.

Study Eligibility

To be eligible for this study, you must meet certain criteria, including but not limited to the following:

  • You have an advanced solid or central nervous system (CNS) tumor with a BRAF alteration confirmed by genetic analysis/testing.
  • Your cancer has persisted despite prior therapy or is considered incurable using standard therapies.
  • Your cancer is measurable on medical imaging scans such as computed tomography, or CT, and magnetic resonance imaging, or MRI.
  • You can care for most of your own personal needs, requiring minimal assistance.
  • You have adequate blood counts and kidney and liver function by routine laboratory tests.
  • You must be 10 years or older and be at least 30 kg (65 lbs).
  • You do not have active liver disease from any cause, including positive screening for hepatitis B or C.
  • If you have a history of clinically significant cardiac disease or congestive heart failure, you may not be eligible for this study. Your doctor will explain this criteria.
There are additional inclusion and exclusion criteria that your study doctor will review with you to determine your eligibility for the study

Trial Details

What are my responsibilities if I enroll in this study?

  • You will take plixorafenib with cobicistat by mouth, as directed by your doctor.
  • The study will involve a weekly visit to a study doctor for the first six weeks, every other week for the next six weeks, and then once every 3 weeks after that. After one year on study, the visits may decrease in frequency.

Measurements/tests that may be taken under a specific schedule include:

  • Because this is an investigational study of plixorafenib, measurements will have to be taken during the clinical trial throughout the time you are enrolled.
  • You will see your doctor for what is called a screening visit. At this visit (which may take place over several days) your doctor will perform tests to confirm if you are eligible for the study. Some of these tests include a physical examination, blood tests, radiology evaluations (CT, MRI, or photographs to measure your disease), and may include a biopsy of your tumor.
  • Vital signs and physical examination, blood tests, tumor biopsies, and radiology evaluations will be performed while you are receiving treatment in the study.

Frequently Asked Questions

Learn More

To learn more about centers participating in the FORTE clinical trial please visit


  1. Mercer, K., et al. Raf proteins and cancer: B-Raf is identified as a mutational target. Biochim Biophys Acta. 2003 Jun 5;1653(1):25-40. doi: 10.1016/s0304-419x(03)00016-7.
  2. De la Fuente MI, et al. Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study. J Clin Oncology. 2023;41(16_suppl): Abstract 3006. Available at:
  3. Yao, Z., et al. RAF inhibitor PLX8394 selectively disrupts BRAF dimers and RAS- independent BRAF-mutant-driven signaling. Nature medicine 25.2 (2019): 284-291.
  4. Fore Biotherapeutics. A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations. Available at: