Clinical Trials in the USA / NCT06607185

Active, not recruiting Phase 1

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

NCT06607185 · tracked via the Priya Life Science USA tracker

Sponsor

Eli Lilly and Company

Phase

Phase 1

Started

2024-10-21

Last updated

2026-07-20

Condition(s) studied

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal CancerAdvanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

LY4066434.CetuximabNab paclitaxelGemcitabineOxaliplatinLeucovorinIrinotecan5FluorouracilCarboplatinCisplatinPemetrexedPembrolizumab

LY4066434.: Administered orally.

Cetuximab: Administered intravenously.

Nab paclitaxel: Administered intravenously.

Gemcitabine: Administered intravenously.

Oxaliplatin: Administered intravenously.

Leucovorin: Administered intravenously.

Irinotecan: Administered intravenously.

5Fluorouracil: Administered intravenously.

Carboplatin: Administered intravenously.

Cisplatin: Administered intravenously.

Pemetrexed: Administered intravenously.

Pembrolizumab: Administered intravenously.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants with Dose-limiting Toxicities (DLTs) — During the first cycle of LY4066434 treatment (up to 28 days)
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Up to approximately 5 years
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Trial sites (45)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
Mayo Clinic	Phoenix	Arizona
City of Hope	Duarte	California
University of California, Los Angeles (UCLA)	Santa Monica	California
Yale University School of Medicine - Yale Cancer Center	New Haven	Connecticut
The University of Chicago Medical Center (UCMC)	Chicago	Illinois
Indiana University (IU)	Indianapolis	Indiana
Massachusetts General Hospital	Boston	Massachusetts
Dana-Farber Cancer Institute	Boston	Massachusetts
South Texas Accelerated Research Therapeutics (START) Midwest	Grand Rapids	Michigan
Columbia University	New York	New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
Duke University Medical Center	Durham	North Carolina
Cleveland Clinic	Cleveland	Ohio
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
Sarah Cannon Research Institute/SCRI	Nashville	Tennessee
SCRI Oncology Partners	Nashville	Tennessee
University of Texas Southwestern	Dallas	Texas
MD Anderson Cancer Center	Houston	Texas
South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
Virginia Cancer Specialists	Fairfax	Virginia
Swedish Cancer Institute (SCI)	Seattle	Washington
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet	Brussels	Belgium
Cliniques universitaires Saint-Luc	Brussels	Belgium
UZ Gent	Ghent	Belgium
Centre Leon Berard	Lyon	France
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona	Hamburg	Germany
SLK-Kliniken Heilbronn GmBH	Heilbronn	Germany
Universitaetsklinikum Wuerzburg	Würzburg	Germany
Centro Ricerche Cliniche di Verona s.r.l.	Verona	Italy
National Cancer Center Hospital East	Chiba	Japan
Kyoto University Hospital	Kyoto	Japan
Shizuoka Cancer Center	Shizuoka	Japan
National Cancer Center Hospital	Tokyo	Japan
Cancer Institute Hospital of JFCR	Tokyo	Japan
Hospital del Mar	Barcelona	Spain
Hospital Universitario Vall d'Hebron	Barcelona	Spain
Institut Catala d'Oncologia - L'Hospitalet	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain

+ 5 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06607185 on ClinicalTrials.gov ↗ ← All trials in the USA