FiH Study 22676 SOS1i in KRASG12C-mutated advanced solids tumours
Research type
Research Study
Full title
Phase 1 study of a SOS1 inhibitor, BAY 3498264, in combination in participants with advanced KRASG12C-mutated solid tumors
IRAS ID
1010502
Contact name
Michael Devoy
Contact email
Sponsor organisation
Bayer AG
Eudract number
2024-513300-34
Clinicaltrials.gov Identifier
Research summary
Advanced solid cancers with KRASG12C mutation are a type of cancer with a specific change called G12C mutation in a protein called KRAS (which stands for Kirsten rat sarcoma virus). The KRAS protein is involved in cell growth and Advanced solid cancers with KRASG12C mutation are a type of cancer with a specific change called G12C mutation in a protein called KRAS (which stands for Kirsten rat sarcoma virus). The KRAS protein is involved in cell growth and survival. Although treatments targeting the KRASG12C mutation are available, these tumors usually become resistant to the treatment, leading to disease progression and a need for additional treatments.
Sotorasib is a drug that targets the mutated KRASG12C protein. It works by binding to the mutated protein and blocking its activity. This helps to stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by the doctors.
BAY 3498264 is a drug that is currently under development for treating advanced solid cancers with KRASG12C mutation. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; so by blocking the activity of SOS1 with BAY 3498264, it is hoped that the benefit offered by treatment with sotorasib may be increased – for example, resulting in a longer or deeper response.
The main purpose of this first-in-human study is to learn how safe BAY 3498264 is when given alone or together with sotorasib and what is the maximum dose of BAY 3498264 that can be safely given to participants together with sotorasib.During the study, participants will first receive BAY 3498264 alone for seven days and then BAY 3498264 in combination with sotorasib.
The treatment will continue for as long as participants benefit from it without any severe medical problems or until they or their doctor decide to stop the treatment.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0267
Date of REC Opinion
21 Oct 2024
REC opinion
Further Information Favourable Opinion