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Study identifier: NCT07535112 Synced from ClinicalTrials.gov · July 29, 2026
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A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation

Condition: Advanced/Metastatic Colorectal Adenocarcinoma  ·  Sponsor: Bayer

PhasePhase 1
Planned participants130
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 or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS. Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon) or the rectum (the section at the end of the bowel). When CRC spreads to other parts of the body, it is called advanced or metastatic CRC. Some people with CRC have the G12D mutation in the KRAS protein. This mutation is linked to a poorer outlook and fewer treatment options. Currently, there are no approved treatments that specifically target this mutation. KRAS is a protein that helps control how cells grow and divide. When it is mutated, it can cause cells to grow uncontrollably, leading to cancer. The study drug, BAY 3771249, is designed to block the activity of KRAS with G12D mutation, which may help slow or stop the growth of cancer cells. BAY 3771249 can be given alone or together with another drug called cetuximab. The main purpose of this study is to learn how safe BAY 3771249 is, how well people tolerate it, how the body processes the drug, and whether it can help shrink or control tumors in people with advanced or metastatic CRC that has the KRAS G12D mutation. The study will also look at how BAY 3771249 works when given alone or with cetuximab, especially in people who have already tried other treatments for their cancer. Researchers will measure, among others: The number and seriousness of h…

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 (21)

Mayo Clinic - Cancer Center - PhoenixPhoenix, Arizona, United StatesNot Yet Recruiting
City of Hope - Duarte Cancer CenterDuarte, California, United StatesNot Yet Recruiting
UC San Diego Health - Moores Cancer CenterSan Diego, California, United StatesNot Yet Recruiting
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke'sDenver, Colorado, United StatesNot Yet Recruiting
Icahn School of Medicine at Mount Sinai - OncologyNew York, New York, United StatesNot Yet Recruiting
NEXT Dallas - Oncology DepartmentIrving, Texas, United StatesRecruiting
START | San AntonioSan Antonio, Texas, United StatesNot Yet Recruiting
Border Medical oncology - Albury Wodonga Regional Cancer CentreAlbury, New South Wales, AustraliaNot Yet Recruiting
Calvary Mater Hospital Newcastle - OncologyWaratah, New South Wales, AustraliaRecruiting
Cabrini Health Oncology ResearchMalvern, Victoria, AustraliaNot Yet Recruiting
Ghent University Hospital | Drug Research Unit DepartmentGhent, BelgiumNot Yet Recruiting
Rigshospitalet - KræftbehandlingCopenhagen, Capital Region, DenmarkNot Yet Recruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07535112