Back to Trials
NCT05503797PHASE2Recruiting

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

Fore Biotherapeutics

Start Date

2/21/2023

Completion Date

12/28/2028

Summary

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.

Eligibility Criteria

Age Range: 8 years to No maximum

Inclusion Criteria Subprotocol A: 1. Male and female, ≥8 years of age, and weighing ≥25 kg. 2. Histologic diagnosis of a solid tumor or primary CNS tumor. 3. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing. 4. Have an archival tissue sample available meeting protocol requirements. 5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory. 6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate. 7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline. Subprotocol B: 1. Male and female, ≥8 years of age, and weighing ≥25 kg. 2. Histological diagnosis of a primary CNS tumor, including but not limited to the following: 1. Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \[NOS\], ganglioglioma, or recurrent LGG). OR 2. Pediatric patients (8-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO \[2021\] Grade 3 or 4 primary CNS tumor. 3. Participants must have unresectable, locally advanced or metastatic disease that: i. Had prior treatment with radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy OR * Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and/or radiotherapy is not considered standard of care may remain eligible for the study. ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate. 3. Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test. 4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test. 5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory. 6. Measurable disease based upon specified response criteria, as determined by the radiographic BICR. 7. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline. 8. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg/day of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments. Subprotocol C: 1. Male and female, ≥8 years of age, and weighing ≥25 kg. 2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic. 3. Measurable disease on CT, MRI, or physical exam 4. Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test. 5. Have an archival tissue sample available meeting protocol requirements. 6. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory 7. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate. Subprotocol D: 1. Male and female, ≥8 years of age, and weighing ≥25 kg. 2. Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols. 3. Measurable disease on CT, MRI, or physical exam. 4. Evidence of BRAF V600E mutation in tumor and/or blood detected by genomic tests. 5. Consent to provide a tumor biopsy. 6. Willingness to comply with the ECG substudy procedures. 7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline. Exclusion Criteria: Subprotocol A: 1. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease. 2. Prior treatment with a MEK inhibitor. 3. Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines. 4. Malignancy with co-occurring activating RAS mutation(s) at any time. 5. Uncontrolled intercurrent illness that would limit compliance with study requirements. 6. HIV infection with exceptions; discuss with treating physician. 7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection). 8. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved. Subprotocol B: 1. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s). 2. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations. 3. Uncontrolled intercurrent illness that would limit compliance with study requirements. 4. Active infection requiring systemic therapy. 5. HIV infection with exceptions; discuss with treating physician. 6. Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). 7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved. Subprotocol C: 1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible). 2. Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC. 3. Participant has CNS metastases. 4. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer). 5. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations. 6. Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1). 7. Uncontrolled intercurrent illness that would limit compliance with study requirements. 8. Active infection requiring systemic therapy. 9. HIV infection with exceptions; discuss with treating physician. Subprotocol D: 1. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations or other co-occurring driver mutations. 2. Participant has a non-CNS solid tumor with CNS metastases. 3. Uncontrolled intercurrent illness that would limit compliance with study requirements. 4. Active infection requiring systemic therapy. 5. HIV infection with exceptions; discuss with treating physician. 6. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes. 7. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure \>160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities (for participants in the ECG substudy).

Interventions

DRUG

Plixorafenib

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cancer Harboring BRAF AlterationsHGGLGGSolid Tumors

Locations

Precision NextGen Oncology & Research Center

Beverly Hills, California 90210

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California 94143

United States

University of California Los Angeles Rheumatology

Westwood, Los Angeles, California 90095-6984

United States

Norwalk Hospital

Norwalk, Connecticut 06856

United States

University of Miami Hospital and Clinics

Miami, Florida 33136

United States

The John Hopkins Hospital

Baltimore, Maryland 21287

United States

Maryland Oncology Hematology- Columbia

Rockville, Maryland 20850

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Massachusetts General Hospital

Boston, Massachusetts 02214

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

St. Luke's Hospital

Duluth, Minnesota 55805

United States

Mosaic Life Care at Saint Joseph - Medical Center

Saint Joseph, Missouri 64506

United States

Nebraska Cancer Specialists - Midwest Cancer Center - Legacy

Omaha, Nebraska 68130

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

Nationwide Children's Hospital

Colombus, Ohio 43205

United States

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

Columbus, Ohio 43221

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Toledo Clinic Cancer Center

Toledo, Ohio 43623

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Lifespan Cancer Institute - Rhode Island Hospital

Providence, Rhode Island 02903

United States

SCRI - TriStar Medical Group Children's Specialists

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Baylor Scott & White Research Institute

Dallas, Texas 75246

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Baylor Scott & White Medical Center

Temple, Texas 43205

United States

University of Washington School of Medicine

Seattle, Washington 98109

United States

West Virginia University Health Sciences Campus

Morgantown, West Virginia 26506

United States

Newcastle Private Hospital

New Lambton Heights, New South Wales 2305

Australia

Orange Health Service

Orange, New South Wales 2800

Australia

Sydney Children's Hospital Network - Randwick

Randwick, New South Wales 2031

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

The Alfred

Melbourne, Victoria 3004

Australia

Sunny brook Health Sciences Centre- Bayview Campus

Toronto, Ontario M4N 3M5

Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

Institut Bergonie

Bordeaux, Aquitaine 33000

France

Hôpital Nord de Marseille

Marseille, Bouches-du-Rhône 13005

France

Hôpital Morvan

Brest, Finistère 29200

France

Institut de Cancerologie de l'Ouest- Angers

Angers, Pays de la Loire Region 49055

France

Gustave Roussy

Villejuif, Val-de-Marne 94805

France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, 31059

France

Hôpital Universitaire Pitié Salpêtrière

Paris, Île-de-France Region 75013

France

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg 69120

Germany

Krankenhaus Nordwest

Frankfurt am Main, Hesse 60488

Germany

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

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

Meldola, Forli-Cesena 47014

Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Naples 80131

Italy

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

Milan, 20132

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Erasmus Medisch Centrum

Rotterdam, South Holland 3015 GD

Netherlands

Haukeland Univeritetssjukehus

Bergen, Hordaland 5021

Norway

Oslo Universitetssykehus-Radiumhospitalet

Oslo, Oslo 0379

Norway

Catholic University of Korea Saint Vincent's Hospital

Suwon, Gyeonggi-do 16247

South Korea

Seoul National University Hospital

Suwon, Gyeonggido 443-721

South Korea

Dong-A University Hospital

Pusan, Gyeongsangnam-do 602-812

South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do 58128

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeoisi 03080

South Korea

Severance Hospital

Seoul, Seoul Teugbyeolsi 03722

South Korea

Hospital Clinico Universitarlo de Santiago

Santiago de Compostela, A Coruña 15706

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona 08035

Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid 28009

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid 28041

Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla 41013

Spain

Hospital Clinico Universitarlo de Valencia

Valencia, Valencia 46010

Spain

Skånes Universitetssjukhus

Lund, Skåne County 221 85

Sweden

Karolinska Universitetssjukhuset

Solna, Stockholm County 171 64

Sweden

The Christie NHS Foundation Trust

Manchester, England M20 4BX

United Kingdom

Sarah Cannon Research Institute

London, W1G 6AD

United Kingdom