Actively Recruiting
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Led by Fore Biotherapeutics · Updated on 2026-04-03
254
Participants Needed
67
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Participants must be male or female aged 10 years or older and weigh at least 30 kg (Subprotocols A, B, C) or between 18 and 65 years (Subprotocol D).
- Histologic diagnosis of solid tumor or primary CNS tumor with specific BRAF gene fusion or BRAF V600E mutation confirmed by validated DNA or RNA sequencing.
- Availability of archival tissue sample or willingness to provide fresh biopsy as required.
- Consent to provide scans prior to baseline to assess tumor changes.
- Disease must be unresectable, locally advanced, metastatic, or recurrent, and measurable by imaging or physical exam.
- Participants must have received all available standard therapies, be intolerant to them, or have investigator determination that standard therapy is inappropriate.
- Adverse events from prior therapies must have resolved to Grade 1 or baseline.
- For participants receiving corticosteroids, doses must be stable or decreasing and not exceed 8 mg/day dexamethasone or equivalent for at least 7 days before first dose (Subprotocol B).
- Willingness to comply with ECG substudy procedures (Subprotocol D).
You will not qualify if you...
- Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations or MEK inhibitors (Subprotocols A and B).
- Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (except neuroendocrine or acinar tumors) and certain other specific tumor exclusions (Subprotocol C).
- Presence of CNS metastases (Subprotocol C and D).
- Known or suspected neurofibromatosis-1 (NF-1) or RAS related gene alterations.
- Uncontrolled illnesses or infections that would limit study compliance.
- HIV infection, with exceptions to be discussed with physician.
- Impaired gastrointestinal function that may affect drug absorption.
- Elevated liver enzymes (AST, ALT, GGT, bilirubin) related to prior immune checkpoint inhibitor treatment.
- Use or anticipated use of medications with risk of QT prolongation or history of significant cardiovascular disease or ECG abnormalities (Subprotocol D).
AI-Screening
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Trial Site Locations
Total: 67 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
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
20
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
Completed
21
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
22
Lifespan Cancer Institute - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
23
SCRI - TriStar Medical Group Children's Specialists
Nashville, Tennessee, United States, 37203
Actively Recruiting
24
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
26
Baylor Scott & White Medical Center
Temple, Texas, United States, 43205
Actively Recruiting
27
University of Washington School of Medicine
Seattle, Washington, United States, 98109
Actively Recruiting
28
West Virginia University Health Sciences Campus
Morgantown, West Virginia, United States, 26506
Actively Recruiting
29
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
30
Orange Health Service
Orange, New South Wales, Australia, 2800
Actively Recruiting
31
Sydney Children's Hospital Network - Randwick
Randwick, New South Wales, Australia, 2031
Actively Recruiting
32
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
33
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
34
Sunny brook Health Sciences Centre- Bayview Campus
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
35
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
36
Institut Bergonie
Bordeaux, Aquitaine, France, 33000
Actively Recruiting
37
Hôpital Nord de Marseille
Marseille, Bouches-du-Rhône, France, 13005
Actively Recruiting
38
Hôpital Morvan
Brest, Finistère, France, 29200
Actively Recruiting
39
Institut de Cancerologie de l'Ouest- Angers
Angers, Pays de la Loire Region, France, 49055
Actively Recruiting
40
Gustave Roussy
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
41
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
42
Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
43
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
44
Krankenhaus Nordwest
Frankfurt am Main, Hesse, Germany, 60488
Active, Not Recruiting
45
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
46
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
47
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Naples, Italy, 80131
Actively Recruiting
48
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
49
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
50
Haukeland Univeritetssjukehus
Bergen, Hordaland, Norway, 5021
Not Yet Recruiting
51
Oslo Universitetssykehus-Radiumhospitalet
Oslo, Norway, 0379
Not Yet Recruiting
52
Catholic University of Korea Saint Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
53
Seoul National University Hospital
Suwon, Gyeonggido, South Korea, 443-721
Actively Recruiting
54
Dong-A University Hospital
Pusan, Gyeongsangnam-do, South Korea, 602-812
Actively Recruiting
55
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
56
Seoul National University Hospital
Seoul, Seoul Teugbyeoisi, South Korea, 03080
Actively Recruiting
57
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
58
Hospital Clinico Universitarlo de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
59
Hospital Clinico Universitarlo de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
60
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
61
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
62
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
63
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
64
Skånes Universitetssjukhus
Lund, Skåne County, Sweden, 221 85
Actively Recruiting
65
Karolinska Universitetssjukhuset
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
66
The Christie NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Actively Recruiting
67
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
J
Jessica Rine
CONTACT
G
Geri Bardelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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