Clareo Health | 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
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
Participant must be ≥18 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 ≤1
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
You may not be if
Leptomeningeal disease or carcinomatous meningitis
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 ≤1 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 ≤2, Autoimmune endocrine disorders Grade ≤2 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
