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Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions, will receive 900 mg of plixorafenib administered with 150 mg of cobicistat once daily (QD), continuously in 3-weeks cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.

Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive 900 mg of plixorafenib administered with 150 mg of cobicistat QD, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.

Plixorafenib

Jessica Rine

Geri Bardelli

Nicholas Butowski

Noah Federman

Macarena De la Fuente

Karisa Schreck

Jeyapalan Suriya

Homam Alkaied

Rony Abou-Jawde

Joel Michalski

Robert Aiken

Luca Szalontay

Eric Sherman

Mark Ranalli

Rex Mowat

Samit Sarangi

Karen Fink

Jennifer Murillo

Sonikpreet Aulakh

Mary Jane Lim-Fay

Antoine Italiano

Pascale Tomasini

Jean-Philippe Metges

Mehdi Touat

Lila Autier

Mihaela Diana Aldea

Antje Wick

Thorsten Oliver Götze

Dominik Modest

Alberto Farolfi

Paolo Ascierto

Andrea Necchi

Byoung Yong Shim

Hyun Woo Lee

Sung Yong Oh

In-Jae Oh

Tae Min Kim

Sang Joon Shin

Alexandra Cortegoso

Valentina Gambardella

Maria Vieito Villar

Atienza Alvaor Lassaletta

Guillermo De Velasco Oria de Rueda

Alejandro Falcon Gonzalez

Ana Carneiro

Jeffrey Yachnin

Colin Lindsay

Elisa Fontana

The objective of this study is to evaluate the efficacy 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 recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol.

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

Fore is committed to sharing with qualified external researchers access to deidentified patient-level data and related study documents (eg. study protocol) from eligible studies following publication of the study results.

ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).

DOR will be determined by standard tumor response criteria.

ORR will be determined by standard tumor response criteria by BICR.

Fore Biotherapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations	NCT05503797	Cancer Harborin...	Plixorafenib Cobicistat	10 Years -	Fore Biotherapeutics
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations	NCT05503797	Cancer Harborin...	Plixorafenib Cobicistat	10 Years -	Fore Biotherapeutics

Spots Global Cancer Trial Database for plixorafenib

Every month we try and update this database with for plixorafenib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.