BAY 3771249 for advanced colorectal cancer with KRAS G12D mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, interventional trial enrolling adults with advanced or metastatic colorectal adenocarcinoma harboring the KRAS G12D mutation. Participants must have measurable disease, ECOG performance status ≤1, and adequate organ function, and they will receive BAY 3771249 either as monotherapy or combined with cetuximab. The study focuses on safety, tolerability, dose finding, and early signals of anti-tumor activity. Sites include three US cancer centers and treatment involves on-site visits for dosing and monitoring.

Why it matters

Who can join: the full rules

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 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 ≤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

Where it's running

• City of Hope - Duarte Cancer Center
  Duarte, California, United States Recruiting
• NEXT Dallas - Oncology Department
  Irving, Texas, United States Recruiting
• START | San Antonio
  San Antonio, Texas, United States Recruiting
• Calvary Mater Hospital Newcastle - Oncology
  Waratah, New South Wales, Australia Recruiting
• National University Hospital Medical Centre
  Singapore, Singapore Recruiting
• National Cancer Center Singapore - Oncology Department
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.