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Clinical Trial NCT06607185 for Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Eli Lilly and CompanyA Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Clinical Trial NCT06607185 is designed to study Treatment for Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor. It is a Phase 1 interventional trial that is recruiting, having started on October 21, 2024, with plans to enroll 750 participants. Led by Eli Lilly and Company, it is expected to complete by January 1, 2030. The latest data from ClinicalTrials.gov was last updated on November 5, 2025.
Brief 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.
Official Title
A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Conditions
Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal CancerAdvanced Solid TumorMetastatic Solid TumorOther Study IDs
- 27237
- J5Q-OX-JRDA (Other Identifier) (Eli Lilly and Company)
NCT ID Number
Start Date (Actual)
2024-10-21
Last Update Posted
2025-11-05
Completion Date (Estimated)
2030-01
Enrollment (Estimated)
750
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
KRAS
KRAS mutation
KRASG12C
KRASG12D
KRASG12V
KRASG12S
KRASG12A
KRASG13D
LY4066434
Targeted therapy
Lung cancer
Pancreas cancer
Colon cancer
Rectal cancer
Colorectal cancer
Ovarian cancer
Endometrial cancer
Cholangiocarcinoma
Esophageal cancer
KRAS-mutant tumor
PanKRAS
Pan KRAS
KRAS mutation
KRASG12C
KRASG12D
KRASG12V
KRASG12S
KRASG12A
KRASG13D
LY4066434
Targeted therapy
Lung cancer
Pancreas cancer
Colon cancer
Rectal cancer
Colorectal cancer
Ovarian cancer
Endometrial cancer
Cholangiocarcinoma
Esophageal cancer
KRAS-mutant tumor
PanKRAS
Pan KRAS
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalLY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | LY4066434. Administered orally. |
ExperimentalLY4066434 Dose Optimization LY4066434 administered orally either alone or with another investigational agent. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Up to approximately 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Response Rate (ORR) | ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) | Up to approximately 5 years |
Best Overall Response (BOR) | BOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Duration of Response (DOR) | DOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Disease Control Rate (DCR) | DCR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Time to Response (TTR) | TTR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone | PK: Cmax of LY4066434 | Predose through Day 168 |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents | PK: Cmax of LY4066434 | Predose through Day 168 |
PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone | PK: Tmax of LY4066434 | Predose through Day 168 |
PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents | PK: Tmax of LY4066434 | Predose through Day 168 |
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone | PK: AUC of LY4066434 | Predose through Day 168 |
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents | PK: AUC of LY4066434 | Predose through Day 168 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Eli Lilly and Company357 active trials to exploreStudy Central Contact
Contact: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
Contact: Physicians interested in becoming principal investigators please contact, [email protected]
56 Study Locations in 9 Countries
Charite Universitaetsmedizin Berlin, Berlin, 10117, Germany
Not yet recruiting
Krankenhaus Nordwest GmbH, Frankfurt, 60488, Germany
Recruiting
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona, Hamburg, 22763, Germany
Recruiting
SLK-Kliniken Heilbronn GmBH, Heilbronn, 74078, Germany
Recruiting
Universitaetsklinikum Wuerzburg, Würzburg, 97080, Germany
Recruiting
Centre Leon Berard, Lyon, 69008, France
Not yet recruiting
Institut Gustave Roussy, Villejuif, 94805, France
Not yet recruiting
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet, Brussels, 1070, Belgium
Recruiting
Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium
Recruiting
UZ Gent, Ghent, 9000, Belgium
Recruiting
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Recruiting
Arizona
Mayo Clinic, Phoenix, Arizona, 85054, United States
Recruiting
California
City of Hope, Duarte, California, 91010, United States
Recruiting
University of California, Los Angeles (UCLA), Los Angeles, California, 90025, United States
Recruiting
Colorado
University of Colorado Denver, Denver, Colorado, 80220, United States
Not yet recruiting
Connecticut
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States
Recruiting
Illinois
The University of Chicago Medical Center (UCMC), Chicago, Illinois, 60637, United States
Recruiting
Indiana
Indiana University (IU), Indianapolis, Indiana, 46202, United States
Recruiting
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Recruiting
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Recruiting
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
Recruiting
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Not yet recruiting
New York
Columbia University, New York, New York, 10032, United States
Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Recruiting
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Recruiting
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
Recruiting
Oklahoma
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Not yet recruiting
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States
Recruiting
Tennessee
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, 37203, United States
Recruiting
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Recruiting
Texas
University of Texas Southwestern, Dallas, Texas, 75244, United States
Recruiting
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Recruiting
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, 78229, United States
Recruiting
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
Recruiting
Washington
Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
Recruiting
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
Not yet recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310006, China
Not yet recruiting
Shandong Province Tumor Hospital, Jinan, 250117, China
Not yet recruiting
Shanghai East Hospital, Tongji University, Shanghai, 0200120, China
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China
Not yet recruiting
Centro Ricerche Cliniche di Verona s.r.l., Verona, 37134, Italy
Recruiting
National Cancer Center Hospital East, Chiba, 277-8577, Japan
Recruiting
Kyoto University Hospital, Kyoto, 606-8507, Japan
Recruiting
Shizuoka Cancer Center, Shizuoka, 411-8777, Japan
Recruiting
National Cancer Center Hospital, Tokyo, 104-0045, Japan
Recruiting
Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan
Recruiting
Hospital del Mar, Barcelona, 08003, Spain
Recruiting
Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain
Recruiting
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, 08908, Spain
Recruiting
Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain
Recruiting
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Recruiting
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Recruiting
Hospital Regional Universitario de Malaga, Málaga, 29010, Spain
Recruiting
National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300195, Taiwan
Recruiting
National Taiwan University Hospital, Taipei, 10016, Taiwan
Recruiting