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New pill targets multiple KRAS mutations in Hard-to-Treat cancers

NCT ID NCT06607185

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new oral drug called LY4066434, which blocks several types of KRAS proteins that drive cancer growth. The study includes up to 750 people with advanced pancreatic, lung, colorectal, or other solid tumors that have specific KRAS mutations. The drug is given alone or combined with other cancer treatments to first check safety and find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4066434 (a Pan-KRAS inhibitor drug taken by mouth)
What this could lead to
If this drug is safe and shows promise, it could lead to a new treatment option for several cancers driven by KRAS mutations, such as pancreatic, lung, and colorectal cancer.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the drug will work. Side effects are unknown, and the drug may not shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma colonic neoplasm colorectal cancer colorectal neoplasm endometrium neoplasm Esophageal Neoplasms lung neoplasm metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer pancreatic ductal adenocarcinoma pancreatic neoplasm rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Colorectal cancer Metastatic solid tumor Non-small cell lung cancer Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Centre Leon Berard

    Lyon, 69373, France

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134, Italy

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Columbia University

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Indiana University (IU)

    Indianapolis, Indiana, 46202, United States

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908, Spain

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488, Germany

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Taiwan University Hospital

    Taipei, 10016, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300195, Taiwan

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SLK-Kliniken Heilbronn GmBH

    Heilbronn, 74078, Germany

  • Sarah Cannon Research Institute/SCRI

    Nashville, Tennessee, 37203, United States

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229, United States

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan, 49546, United States

  • Swedish Cancer Institute (SCI)

    Seattle, Washington, 98104, United States

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • Universite Libre de Bruxelles (ULB) - Institut Jules Bordet

    Brussels, 1070, Belgium

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles (UCLA)

    Santa Monica, California, 90404, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Southwestern

    Dallas, Texas, 75244, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Yale University School of Medicine - Yale Cancer Center

    New Haven, Connecticut, 06520-8028, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.