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

Launched by ELI LILLY AND COMPANY · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY4066434, which is designed to target specific mutations in a gene called KRAS found in certain types of cancer. The trial focuses on patients with solid tumors like pancreatic cancer, lung cancer, and colorectal cancer that have specific KRAS mutations. The main goal is to see if LY4066434 is safe and how well it works when given alone or with other treatments. The study will take place over about five years and is currently looking for participants.

To join the trial, patients must have a confirmed KRAS mutation in their tumor and be diagnosed with an advanced or metastatic solid tumor that can’t be surgically removed. Participants should be between the ages of 65 and 74, be able to take tablets, and not be pregnant or breastfeeding. During the trial, participants will receive the study drug and will be monitored closely for any side effects. It’s important to note that some patients with specific health conditions, such as certain types of infections or heart issues, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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, 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) and 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