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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513578-23-00

Acronym

F8394-201

Enrollment

129

Registered

2024-08-22

Start date

2023-03-21

Completion date

Unknown

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors harboring BRAF alterations

Brief summary

1. Objective Response Rate (ORR) (Subprotocol A, B and C): ORR will be determined by standard tumor response criteria by blinded independent central review (BICR), 2. Pharmacokinetics (Subprotocol D): Systemic exposure of plixorafenib measured by Cmax and AUC.

Interventions

DRUGTybost 150 mg film-coated tablets

DRUGCOBICISTAT

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Objective Response Rate (ORR) (Subprotocol A, B and C): ORR will be determined by standard tumor response criteria by blinded independent central review (BICR), 2. Pharmacokinetics (Subprotocol D): Systemic exposure of plixorafenib measured by Cmax and AUC.	—

Countries

France, Germany, Italy, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026