RecruitingPhase 2NCT05503797

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

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

Sponsor

Fore Biotherapeutics

Enrollment

254 participants

Start Date

Feb 21, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumors HGG Cancer Harboring BRAF Alterations LGG

Summary

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.

Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study tests FORE8394 (also called plixorafenib), a new cancer drug, in people whose tumors have BRAF gene changes (mutations or fusions) — including brain tumors, rare solid tumors, and other cancers. It is an umbrella trial with multiple sub-studies (subprotocols). You may be eligible if: - You are 10 years old or older (18+ for some subprotocols) and weigh at least 30 kg - Your tumor has a confirmed BRAF fusion or BRAF V600E mutation - You have already received standard therapies or are not a candidate for them - All prior treatment side effects have resolved to mild or baseline levels You may NOT be eligible if: - You have previously been treated with BRAF, MEK, or ERK inhibitors (for most subprotocols) - Your tumor also has a RAS mutation - You have uncontrolled illness, active infection, or HIV - You have significant gastrointestinal problems affecting oral drug absorption - You have serious cardiac conditions or QT prolongation risk (for Subprotocol D) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlixorafenib

Oral tablets

Locations(69)

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of California Los Angeles Rheumatology

Westwood, Los Angeles, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

University of Miami Hospital and Clinics

Miami, Florida, United States

The John Hopkins Hospital

Baltimore, Maryland, United States

Maryland Oncology Hematology- Columbia

Rockville, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

St. Luke's Hospital

Duluth, Minnesota, United States

Mosaic Life Care at Saint Joseph - Medical Center

Saint Joseph, Missouri, United States

Nebraska Cancer Specialists - Midwest Cancer Center - Legacy

Omaha, Nebraska, United States

Overlook Medical Center

Summit, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Lifespan Cancer Institute - Rhode Island Hospital

Providence, Rhode Island, United States

SCRI - TriStar Medical Group Children's Specialists

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Baylor Scott & White Medical Center

Temple, Texas, United States

University of Washington School of Medicine

Seattle, Washington, United States

West Virginia University Health Sciences Campus

Morgantown, West Virginia, United States

Newcastle Private Hospital

New Lambton Heights, New South Wales, Australia

Orange Health Service

Orange, New South Wales, Australia

Sydney Children's Hospital Network - Randwick

Randwick, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

The Alfred

Melbourne, Victoria, Australia

Sunny brook Health Sciences Centre- Bayview Campus

Toronto, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Institut Bergonie

Bordeaux, Aquitaine, France

Hôpital Nord de Marseille

Marseille, Bouches-du-Rhône, France

Hôpital Morvan

Brest, Finistère, France

Institut de Cancerologie de l'Ouest- Angers

Angers, Pays de la Loire Region, France

Gustave Roussy

Villejuif, Val-de-Marne, France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, France

Hôpital Universitaire Pitié Salpêtrière

Paris, Île-de-France Region, France

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

Meldola, Forli-Cesena, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Naples, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Haukeland Univeritetssjukehus

Bergen, Hordaland, Norway

Oslo Universitetssykehus-Radiumhospitalet

Oslo, Norway

Catholic University of Korea Saint Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Suwon, Gyeonggido, South Korea

Dong-A University Hospital

Pusan, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeoisi, South Korea

Severance Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Clinico Universitarlo de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital Clinico Universitarlo de Valencia

Valencia, Valencia, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Skånes Universitetssjukhus

Lund, Skåne County, Sweden

Karolinska Universitetssjukhuset

Solna, Stockholm County, Sweden

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05503797

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