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Study identifier: NCT06659341 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

Condition: Advanced Solid Tumors Harboring KRAS G12C Mutation  ·  Sponsor: Bayer

PhasePhase 1
Planned participants104
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation. Sotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by doctors. However, when sotorasib works, it normally only works for a period of time, after which the cancer starts to grow again, and the patient may need a different treatment. BAY3498264 is a drug that is currently under development. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; by blocking the activity of SOS1 with BAY3498264, 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 BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib. During the study, participants will receive the following treatments: * BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days. * Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264. The treatment …

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

Always discuss trial participation with your own doctor first.

Locations (10)

Border Medical oncology - Albury Wodonga Regional Cancer CentreAlbury, New South Wales, AustraliaRecruiting
Macquarie University Hospital - Oncology DepartmentMacquarie Park, New South Wales, AustraliaRecruiting
Peninsula and Southeast OncologyFrankston, Victoria, AustraliaRecruiting
Rigshospitalet Copenhagen University Hospital | Oncology DepartmentCopenhagen, Capital Region, DenmarkRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia MedicaRome, Lazio, ItalyRecruiting
Humanitas Mirasole S.p.A. - Oncologia Medica ed EmatologiaRozzano, ItalyRecruiting
Institut Catala D'oncologia | Hospitalet | OncologiaL'Hospitalet de Llobregat, Barcelona, SpainRecruiting
Hospital Universitari Vall D Hebron | OncologiaBarcelona, SpainNot Yet Recruiting
The Christie NHS Foundation Trust - Christie HospitalManchester, Greater Manchester, United KingdomRecruiting
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - SuttonSutton, Surrey, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06659341