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

Running, not enrolling · Phase 1

Conditions studied: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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.

Key facts

Study ID

NCT06607185

Run by

Eli Lilly and Company

People needed

750

Starts

2024-10-21

Expected to finish

2030-01-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• University of California, Los Angeles (UCLA) — Santa Monica, California, United States
• Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut, United States
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
• Indiana University (IU) — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States
• Columbia University — New York, New York, United States
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute/SCRI — Nashville, Tennessee, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Swedish Cancer Institute (SCI) — Seattle, Washington, United States
• Universite Libre de Bruxelles (ULB) - Institut Jules Bordet — Brussels, Belgium
• Cliniques universitaires Saint-Luc — Brussels, Belgium
• UZ Gent — Ghent, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.