← TrialsClinicalTrials.gov
NCT07535112phase 1recruiting
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
130
Enrollment · estimated
10
Countries · 21 sites
2029-07
Primary completion
2 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Biomarker requirement language
- Histologically/pathologically documented diagnosis of advanced/metastatic adenocarcinoma of the colon and rectum.
Change timeline
Signals from this trial
- New trial48/100Opportunity
New phase 1 trial NCT07535112 posted by Bayer: "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".
Eligibility — raw, for validation
Inclusion Criteria: * KRAS G12D mutated solid tumor * 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 Exclusion Criteria: * Leptomeningeal disease or carcinomatous meningitis * 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 ≤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