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โ† Trials
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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

RecruitingPhase 1Ages 18 Years - anyAllBayer
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * KRAS G12D mutated solid tumor * Participant must be โ‰ฅ18 years old or the legal age of consent in the jurisdiction in which the study is taking place when signing the screening ICF * At least one measurable lesion as per RECIST v1.1. outside the CNS * Eastern Cooperative Oncology Group performance status (ECOG PS) of โ‰ค1 * Male or Female: Contraceptive use by participant or participant's partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Life expectancy of at least 3 months in the opinion of the Investigator * Histologically/pathologically documented diagnosis of advanced/metastatic adenocarcinoma of the colon and rectum. * Adequate hematologic and end-organ function Exclusion Criteria: * Leptomeningeal disease or carcinomatous meningiti * Uncontrolled and/or active/symptomatic brain metastases. * Significant traumatic injury or major surgical procedure within 4 weeks of first dose of study intervention * Known hypersensitivity to any component of study intervention * Previous (within 3 years) or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the respective substudy. * Active infection requiring systemic anti-infective therapy within 14 days of first dose of study intervention * Known HIV infection * Active Hepatitis B virus (HBV) infection * Active Hepatitis C virus (HCV) infection * Significant cardiac disorder * History of risk factors for torsade de pointes (TdP) (e.g., heart failure, family history of long QT syndrome) * Participants with inadequately managed diabetes as assessed by the Investigator * Toxicities from prior anticancer therapy, defined as not having resolved to Grade โ‰ค1 or as specified in the respective substudy protocol as per NCI CTCAE v.6.0 with the following exceptions: Alopecia of any grade, Peripheral neuropathy Grade โ‰ค2, Autoimmune endocrine disorders Grade โ‰ค2 managed with stable endocrine replacement therapy * History of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis (unless it has resolved without sequelae without use of steroids), or any evidence of clinically-active pneumonitis/ILD * History of the following eye disorders: keratitis, ulcerative keratitis
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What it tests

  • BAY 3771249
  • Cetuximab
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Where

21 sites
Mayo Clinic - Cancer Center - Phoenix
Phoenix, United States
City of Hope - Duarte Cancer Center
Duarte, United States
UC San Diego Health - Moores Cancer Center
San Diego, United States
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, United States
Icahn School of Medicine at Mount Sinai - Oncology
New York, United States
NEXT Dallas - Oncology Department
Irving, United States
START | San Antonio
San Antonio, United States
Border Medical oncology - Albury Wodonga Regional Cancer Centre
Albury, Australia

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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