A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant Solid Tumors
Study of Investigational Medication for KRAS Mutant Solid Tumors
Greg Durm, MD
Primary Investigator
Brief description of study
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced Solid Tumor, Colorectal Cancer, Metastatic Solid Tumor, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
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Age: 18 years - 100 years
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Gender: All
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
This study investigates an investigational medication for people with solid tumors that have specific KRAS mutations. These mutations are changes in a gene that can affect how cells grow. The purpose of this study is to understand if the investigational medication is safe and can be tolerated by patients with these types of tumors.
Participants will receive the investigational medication alone or with other treatments. The study will have two parts: one to find the right dose and another to optimize it. This will help determine the best way to use the medication.
- Who can participate: Adults with specific KRAS mutations in their solid tumors may be eligible. Participants should have a good performance status and be able to swallow tablets. Those with certain other health conditions or active infections may not qualify.
- Study details: Participants will take the investigational medication, either alone or with other treatments. They will be monitored for safety and how well they tolerate the medication. A placebo is not used in this study.
- Study timelines: The study will last up to 5 years.
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