Efficacy and Safety of FORE8394 in Participants With Advanced Cancer Harboring BRAF Alterations
Research type
Research Study
Full title
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
IRAS ID
1006314
Contact name
Stacie Shepherd
Contact email
Sponsor organisation
Fore Biotherapeutics
Eudract number
2022-000627-20
Clinicaltrials.gov Identifier
Research summary
This is a global trial (Europe, North America, South Korea) to further study the efficacy and safety of a new drug (FORE8394) at its previously established dose in patients with tumours associated with a mutation in the BRAF gene. FORE8394 is taken daily by mouth, as long as the drug is either shrinking the tumour or preventing its growth and a patient is tolerating the treatment.
One of the studies is for patients with the BRAF fusion gene mutation tumours of the internal organs that cannot be surgically treated, had metastasized, or for brain tumours that reoccurred or progressed with prior treatments. The other study is for patients with BRAF V600E gene mutation brain tumours that reoccurred or progressed on prior treatments. A total of about 135 patients will be enrolled in these studies.
To participate in this trial patients should not have had serious heart, kidney, liver, and blood conditions, and cannot be pregnant or breastfeeding. There are other genes and health conditions that could render FORE8394 not suitable for the treatment of a specific patient. Sexually active women and men will be asked to use contraceptives, while on treatment. Some of the commonly used medications may interact with FORE8394 and cannot be taken while on the study (can be substituted).
This trial is for patients 10 years of age and older who received prior cancer treatment. Patients will be regularly examined by medical personnel, which include but are not limited to radiological tests (MRI or CT, with or without contrast, depending on tumour type), blood tests, and cardiogram, and may involve tumour biopsy, if not previously done. Results of FORE8394 effect on patients’ health will be recorded and shared with the National Health Authorities (to decide if this drug should be used in other patients) but no patient’s personal information will be disclosed.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0406
Date of REC Opinion
19 May 2023
REC opinion
Further Information Favourable Opinion