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NCT06607185Active, not recruitingPhase 1

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

A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
750 (estimated)
First submitted
19 Sept 2024
Start date
21 Oct 2024
Primary completion date
31 Jan 2030
Lead sponsor
Eli Lilly and Company
NCT number
NCT06607185
EU CT number
2024-516733-12-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 750
  • From 21 Oct 2024 to the primary completion date, 31 Jan 2030
  • 47 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

Other illness

  • 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

Lab values

  • 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.

Other

  • Have known active CNS metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyCompleted
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyCompleted
SLK-Kliniken Heilbronn GmbH
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HeilbronnGermanyCompleted
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Centre Leon Berard
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LyonFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
National Cancer Center Hospital East
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ChibaJapanUnknown status
Kyoto University Hospital
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KyotoJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
National Taiwan University Hospital Hsin Chu Branch
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HsinchuTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
The University of Chicago Medical Center (UCMC)
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
University of Texas, Southwestern
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DallasUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
South Texas Accelerated Research Therapeutics (START) Midwest
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Grand RapidsUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Indiana University (IU)
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IndianapolisUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
Sarah Cannon Research Institute SCRI
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NashvilleUnited StatesUnknown status
Yale University School of Medicine - Yale Cancer Center
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New HavenUnited StatesUnknown status
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
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New YorkUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
Mayo Clinic
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PhoenixUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
South Texas Accelerated Research Therapeutics (START)
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San AntonioUnited StatesUnknown status
University of California, Los Angeles (UCLA)
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Santa MonicaUnited StatesUnknown status
Swedish Cancer Institute (SCI)
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SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.