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A Study of BAY 3771249 and Cetuximab for Advanced Colorectal Cancer with KRAS G12D Mutation

This study is looking for a better way to treat advanced or metastatic colorectal cancer (cancer that has spread) that has a specific change (mutation) in a protein called KRAS, known as the G12D mutation. Researchers are testing a new oral drug, BAY 3771249, along with an existing intravenous (IV) drug called Cetuximab. The main goals are to see how safe these treatments are and if they cause side effects over about two years. You might be able to join if you are 18 or older, have this specific KRAS G12D mutation in your tumor, and have measurable cancer outside your brain or spinal cord. This study aims to enroll 130 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 130 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 2 years to monitor for side effects and changes in vital signs.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07535112

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bayer
~130 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:BAY 3771249Cetuximab

At a glance

Recruiting sites
3 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Treatment-emergent adverse events (TEAEs)
Measured over Up to approximately 2 years.
+9 more outcomes measured

Conditions

Advanced/Metastatic Colorectal Adenocarcinoma

Explore related trials

Colorectal CarcinomaGTPase KRas

Where it's being run

21 sites across 16 states
California2
Texas2
New South Wales2
Singapore2
Spain2
Arizona1
Colorado1
New York1

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with Treatment-emergent adverse events (TEAEs)Up to approximately 2 years.

    Applicable in Dosage escalation and expansion

  • Severity of TEAEsUp to approximately 2 years.

    Applicable in Dosage escalation and expansion

  • Change from baseline in vital signs: Pulse rateUp to approximately 2 years

    Applicable in Dosage escalation and expansion

  • Change from baseline in vital signs: Oxygen saturationUp to approximately 2 years

    Applicable in Dosage escalation and expansion

  • Change from baseline in vital signs: Respiratory rateUp to approximately 2 years

    Applicable in Dosage escalation and expansion

  • Change from baseline in vital signs: Blood pressureUp to approximately 2 years

    Applicable in Dosage escalation and expansion

  • Change from baseline in vital signs: Body temperatureUp to approximately 2 years

    Applicable in Dosage escalation and expansion

  • Change from baseline in laboratory test resultsUp to approximately 2 years

    Hematology, serum chemistry, urinalysis and coagulation tests. Applicable in Dosage escalation and expansion

  • Number of participants experiencing a dose-limiting toxicity (DLT) at each dosageUp to approximately 3 weeks

    Applicable in Dose escalation part

  • Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1Up to approximately 2 years

    Applicable in Dosage escalation and expansion