The trial is evaluating FORE8394 with cobicistat in patients with solid or central nervous system tumours. Credit: EUSKALANATO / Flickr (Creative Commons).

Fore Biotherapeutics has dosed the first participant in the global Phase II FORTE clinical trial of FORE8394 in solid or central nervous system (CNS) tumour patients with BRAF gene fusions and recurrent primary CNS tumours with BRAFV600E mutations refractory to standard therapies.

The trial builds upon the ongoing Phase I/IIa clinical trial’s design and interim data.

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This Phase I/IIa clinical trial is assessing FORE8394 to treat advanced solid and CNS tumours with BRAF alterations.

The single-arm, multi-center, open-label, international Phase II trial has been designed for assessing the efficacy and safety of FORE8394, along with pharmacokinetic booster cobicistat, in cancer harbouring BRAF alterations patients aged ten years and above.

Nearly 130 participants are planned to be enrolled in two subprotocols, including recurrent primary CNS tumours harbouring BRAFV600E mutations patients, and locally advanced or metastatic solid tumours or recurrent or progressive primary CNS tumours harbouring BRAF fusions, excluding colorectal or pancreatic ductal adenocarcinoma patients.

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In the trial, FORE8394 900mg will be co-administered orally along with cobicistat 150mg once a day.

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Overall response rate and duration of response is the primary endpoint of each subprotocol.

Fore Biotherapeutics chief medical officer Stacie Shepherd said: “FORE8394, our next-generation BRAF paradox breaker, provides the potential for single agent clinical activity for both BRAF V600 mutations and BRAF fusions without MAPK pathway activation, avoiding the resistance and toxicities observed with the earlier-generation BRAF inhibitors.

“Advancing this novel therapy to address patients’ needs is the driving force behind our team’s mission to advance FORE8394 through the clinic.”

The company expects to receive mature data from the Phase I/IIa clinical trial in the middle of this year.