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Luciann Nguyen
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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

Bayer

ClinicalTrials.gov
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

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    48/100
    Opportunity

    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".

    ClinicalTrials.gov record updated 64 days ago.

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