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Clinical Trials in Spain / 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 Spain 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.Cetuximab →Nab paclitaxel →Gemcitabine →Oxaliplatin →Leucovorin →Irinotecan →5Fluorouracil →Carboplatin →Cisplatin →Pemetrexed →Pembrolizumab →

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
No
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)

FacilityCityRegionStatus
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

📄 Keytruda (pembrolizumab) drug profile →

More Eli Lilly and Company trials in Spain

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A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 Active, not recruiting
A Study of Brenipatide in Adult Participants With Major Depressive Disorder Recruiting

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Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). Active, not recruiting
Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET Active, not recruiting
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) Recruiting
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) Active, not recruiting
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 Spain