Clinical trials are research studies that aim to answer our scientific questions so that we can best accomplish our goal of treating rare cancers. These trials are one of the primary ways we can evaluate the potential success of our innovative treatments.
Plixorafenib is a small molecule that targets cancer cells with a mutated BRAF gene. Unlike conventional chemotherapy, this targeted therapy spares healthy cells, as their BRAF gene is not mutated.
Our cells’ BRAF gene contains instructions for making BRAF proteins. BRAF proteins are large molecules that work with other proteins to relay a signal that tells the cell that it’s time to grow and divide. Changes, or mutations, 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. Plixorafenib is designed to slow tumor growth by locking into and silencing mutant BRAF proteins, thereby switching off the rogue cell division signal.
Plixorafenib is designed to block only mutated BRAF proteins. Most BRAF mutations are not inherited; instead, they usually develop after birth and only in certain cells. Plixorafenib can slow tumor growth by blocking the multiplication of only these mutant cells, while sparing cells with normal BRAF genes. This selectivity means fewer side effects than traditional chemotherapies, which kill any rapidly reproducing cell, including healthy ones.
Studies show that plixorafenib is potentially safer and more effective than earlier-generation BRAF-inhibitors. These early-generation inhibitors only target the most common BRAF mutations, and paradoxically, can even amplify cancerous activity in certain mutant cells. By contrast, plixorafenib appears to inhibit a wider range of BRAF mutations, both common and rare, and does not trigger the paradoxical amplification seen with early-generation BRAF inhibitors.
Fore is running a clinical trial open for select patients with BRAF alterations, as detailed in the NCT05503797 study protocol.
Title
F8394-201 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.
Purpose
The purpose of this study is to assess the effectiveness and safety of the investigational drug plixorafenib (previously Fore8394 or PLX-8394) in patients with advancedsolid tumors that contain an altered form of a gene called BRAF. Certain mutations or “translocations” in the BRAF gene cause a change in the BRAF protein that can promote cancer growth and spread. Plixorafenib works by preventing these altered BRAF proteins from working, thereby blocking the growth and spread of cancer cells.
Phase
2
Identifier
NCT05503797
Sponsor
Fore Bio
3675 Market Street
Suite 200
Philadelphia, PA 19104
267-641-7575
Clinical Trial Diversity, Equity, and Inclusiveness initiatives are important for ensuring the participation of relevant and underrepresented populations in the development program of any potential new therapy. Recognizing the existence of health disparities and differential access to health care in certain populations, Fore is committed to recruiting and retaining a diverse participant population that reflects the demographics of cancer patients with BRAF alterations. Fore has put measures in place to facilitate access to plixorafenib clinical trials for all eligible participants through a number of strategies.
For patients with BRAF-mutated tumors who are not eligible to participate in clinical trials conducted by Fore Bio and who have no other treatment options, Fore may consider providing plixorafenib, as defined in our expanded access policy.