A Phase 1/2 Study of CFT1946 In Subjects with BRAF-V600 Mutant Solid Tumors
Research type
Research Study
Full title
A phase 1/2 open-label multicenter trial to characterize the safety, tolerability, And preliminary efficacy of CFT1946 as monotherapy and combination therapy in subjects with BRAF-V600 mutant solid tumors.
IRAS ID
1008417
Contact name
Len Reyno
Contact email
Sponsor organisation
C4 Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Braf-v600 mutant solid tumour is a type of cancer where the protein controlling the cell growth, known as BRAF, is not working well due to a change in that protein (called a BRAF mutant). C4 therapeutics Inc., has developed an experimental medication called CFT1946 which is being developed as a treatment for BRAF-V600 Mutant Solid Tumours. This study will investigate the study medication, CFT1946 by itself and in combination with another study medication called trametinib and cetuximab, also known as MEKINIST® and ERBITUX® respectively. Trametinib is a medication that works by blocking MEK1 and MEK2 activity. MEK1 and MEK2 are proteins activated by the BRAF mutant, playing an active role in controlling cell growth. Trametinib is already approved for treatment of melanoma (a type of skin cancer) with BRAF mutations by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA). Cetuximab is a medicine that blocks a protein is an epidermal growth factor receptor which, when over-produced in cancer cells can affect the tumour growth and the status of disease. Cetuximab is already approved by the FDA and EMA for people with CRC and head and neck cancer. This clinical study has two parts (Phase 1 and Phase 2), participants in the United Kingdom will take part in both Phase 1 and Phase 2 of this study: In Phase 1 (Dose Escalation) The Dose Escalation (Phase 1) is designed to evaluate the safety and tolerability of CFT1946, as well as to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CFT1946 as monotherapy and in combination with trametinib (CFT1946 + trametinib) and cetuximab (CFT1946 + cetuximab). In Phase 2 (Dose Expansion) Participants will be treated with CFT1946 at the maximum tolerated or recommended dose determined in Phase 1 (Dose Escalation) and/or treated with CFT1946 in combination with trametinib and cetuximab. Approximately 206 participants expected to be enrolled in this study globally.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0396
Date of REC Opinion
26 Jun 2024
REC opinion
Further Information Favourable Opinion