An official website of the United States government
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06607185.
