A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant Solid Tumors
Study of an 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
-
Age: 18 years - 100 years
-
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 the safety and tolerability of an investigational medication in participants with locally advanced or metastatic solid tumors that have specific KRAS mutations. KRAS mutations are changes in a gene that can affect cell growth and division, leading to cancer. The study includes participants with KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutations.
Participants will receive the investigational medication either alone or in combination with other treatments. The study is divided into two parts: monotherapy dose escalation, where different doses of the investigational medication are tested, and dose optimization, which aims to find the most effective dose with the fewest side effects.
- Who can participate: Adults with locally advanced or metastatic solid tumors with specific KRAS mutations, measurable disease per RECIST 1.1, and an ECOG performance status of 0 or 1 are eligible. Participants must not be pregnant or breastfeeding and should be able to swallow tablets.
- Study details: Participants will take the investigational medication, which may be given alone or with other treatments. It is important for participants to follow the study procedures and report any side effects. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, will not be used in this study.
- Study timelines: The study will last up to 5 years.
Find a site
,
Send a message
Enter your contact details to connect with study team
Primary Contact
