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
- Diseases
- Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Completed |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| National Taiwan University Hospital Hsin Chu Branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The University of Chicago Medical Center (UCMC) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| South Texas Accelerated Research Therapeutics (START) Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University (IU) Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Sarah Cannon Research Institute SCRI Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School of Medicine - Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| South Texas Accelerated Research Therapeutics (START) Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of California, Los Angeles (UCLA) Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Swedish Cancer Institute (SCI) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.