Active Not RecruitingPhase 1NCT06607185

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

Checked against the public recordLast updated Jul 20, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations45
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: LY4066434.; Drug: Cetuximab; Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5Fluorouracil; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA * Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer * Have measurable disease per RECIST 1.1 * Have an ECOG performance status of ≤1 * Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention * Must be able to swallow tablets * Participants with asymptomatic or treated CNS disease may be eligible Exclusion Criteria: * Have known active CNS metastases and/or carcinomatous meningitis * Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, hearing loss, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy * Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias. * Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) or untreated HIV infection * Have other active malignancy unless in remission with life expectancy greater than 2 years. * Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection * Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • Mayo ClinicPhoenix, Arizona
  • City of HopeDuarte, California
  • University of California, Los Angeles (UCLA)Santa Monica, California
  • Yale University School of Medicine - Yale Cancer CenterNew Haven, Connecticut
  • The University of Chicago Medical Center (UCMC)Chicago, Illinois
  • Indiana University (IU)Indianapolis, Indiana
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, Michigan
  • Columbia UniversityNew York, New York
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2026. Always confirm current availability with the study team.

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