Actively Recruiting
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
Led by Fore Biotherapeutics · Updated on 2026-06-05
254
Participants Needed
70
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of plixorafenib in people with advanced or metastatic solid tumors, including primary central nervous system tumors, that have specific BRAF gene alterations. The study focuses on participants with BRAF fusions or rare BRAF V600 mutations in tumors like melanoma, thyroid cancer, or recurrent CNS tumors. This is a Phase 2 trial aiming to understand how well plixorafenib works in these cancer types. Participants receive plixorafenib as oral tablets continuously in 3-week cycles. The dose may be increased as tolerated and treatment continues until the disease progresses, unacceptable side effects occur, or other reasons lead to stopping. The study includes different groups based on tumor types and BRAF mutation status, including unresectable solid or CNS tumors with BRAF fusions, recurrent CNS tumors with BRAF V600E mutations, and advanced rare non-CNS solid tumors with BRAF V600E mutations. During the trial, participants will have scans and tests before starting treatment to assess tumor changes. Researchers will monitor tumor response, duration of response, progression-free survival, overall survival, and treatment side effects for up to four years. Blood samples will be taken to study how the drug is processed in the body. Participants will be closely followed throughout the study to evaluate the drug's effects and safety.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 10 years or older and weighing at least 30 kg
- Histologic diagnosis of a solid tumor or primary central nervous system tumor
- Documented BRAF gene fusion or BRAF V600E mutation detected by validated genetic testing
- Availability of an archival tissue sample meeting protocol requirements
- Consent to provide scans before baseline to assess tumor changes
- Have received all available standard therapies, are intolerant to standard therapies, or treatment with standard therapy is not appropriate
- All side effects from prior treatments must have resolved to Grade 1 or baseline
- Measurable disease as determined by imaging or physical exam (for applicable subprotocols)
- Willingness to comply with study procedures including biopsies and ECG substudy (for specific subprotocols)
You will not qualify if you...
- Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations or MEK inhibitors (specific to some subprotocols)
- Presence of malignancies with co-occurring activating RAS mutations
- Uncontrolled illness that limits compliance with study requirements
- HIV infection with exceptions as discussed with treating physician
- Gastrointestinal conditions that affect absorption of oral plixorafenib
- Grade 2 or higher liver enzyme changes attributed to prior immune checkpoint inhibitor treatment
- Known or suspected neurofibromatosis-1 or RAS related gene alterations
- Active infection requiring systemic therapy
- Presence of CNS metastases (for specific subprotocols)
- Use or anticipated need for medications that prolong QT interval or history of significant heart conditions
- Hypertension with systolic blood pressure over 160 mm Hg or significant ECG abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive plixorafenib orally in repeated 3-week cycles. Treatment continues until disease progression, unacceptable toxicity, or other reasons for withdrawal.
Visits occur regularly during treatment cycles as per protocol
Trial Site Locations
Total: 70 locations
1
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States, 90210
Actively Recruiting
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
3
University of California Los Angeles Rheumatology
Westwood, Los Angeles, California, United States, 90095-6984
Actively Recruiting
4
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Actively Recruiting
5
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
6
The John Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
Maryland Oncology Hematology- Columbia
Rockville, Maryland, United States, 20850
Actively Recruiting
8
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
11
St. Luke's Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
12
Mosaic Life Care at Saint Joseph - Medical Center
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
13
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, Nebraska, United States, 68130
Actively Recruiting
14
Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
15
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
18
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
19
The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43221
Actively Recruiting
20
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
21
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
Completed
22
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
23
Lifespan Cancer Institute - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
24
SCRI - TriStar Medical Group Children's Specialists
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
27
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
28
Baylor Scott & White Medical Center
Temple, Texas, United States, 43205
Actively Recruiting
29
University of Washington School of Medicine
Seattle, Washington, United States, 98109
Actively Recruiting
30
West Virginia University Health Sciences Campus
Morgantown, West Virginia, United States, 26506
Actively Recruiting
31
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
32
Orange Health Service
Orange, New South Wales, Australia, 2800
Actively Recruiting
33
Sydney Children's Hospital Network - Randwick
Randwick, New South Wales, Australia, 2031
Actively Recruiting
34
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
35
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
36
Sunny brook Health Sciences Centre- Bayview Campus
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
37
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
38
Institut Bergonie
Bordeaux, Aquitaine, France, 33000
Actively Recruiting
39
Hôpital Nord de Marseille
Marseille, Bouches-du-Rhône, France, 13005
Actively Recruiting
40
Hôpital Morvan
Brest, Finistère, France, 29200
Actively Recruiting
41
Institut de Cancerologie de l'Ouest- Angers
Angers, Pays de la Loire Region, France, 49055
Actively Recruiting
42
Gustave Roussy
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
43
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
44
Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
45
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
46
Krankenhaus Nordwest
Frankfurt am Main, Hesse, Germany, 60488
Active, Not Recruiting
47
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
48
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
49
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Naples, Italy, 80131
Actively Recruiting
50
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
51
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
52
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
53
Haukeland Univeritetssjukehus
Bergen, Hordaland, Norway, 5021
Actively Recruiting
54
Oslo Universitetssykehus-Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
55
Catholic University of Korea Saint Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
56
Seoul National University Hospital
Suwon, Gyeonggido, South Korea, 443-721
Actively Recruiting
57
Dong-A University Hospital
Pusan, Gyeongsangnam-do, South Korea, 602-812
Actively Recruiting
58
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
59
Seoul National University Hospital
Seoul, Seoul Teugbyeoisi, South Korea, 03080
Actively Recruiting
60
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
61
Hospital Clinico Universitarlo de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
62
Hospital Clinico Universitarlo de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
63
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
64
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
65
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
66
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
67
Skånes Universitetssjukhus
Lund, Skåne County, Sweden, 221 85
Actively Recruiting
68
Karolinska Universitetssjukhuset
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
69
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Actively Recruiting
70
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
J
Jessica Rine
G
Geri Bardelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here