> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-the-pan-kras-inhibitor-ly4066434-in-participants-4c7afe7f-2cf0-4953-8ade-34516e33090d > Record changed: 2026-10-13 # A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors NCT06607185 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Participants 750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Start date 2024-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Short title** A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Official title** A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Dates **Completion date** 2030-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **First posted** 2024-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Primary completion date** 2030-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Start date** 2024-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Size and sites **Participants** 750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Planned participants** 750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Identifiers **Registry ID** NCT06607185 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **ClinicalTrials.gov ID** NCT06607185 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Outcomes ### Primary outcomes 1. Number of Participants with Dose-limiting Toxicities (DLTs) Timeframe: During the first cycle of LY4066434 treatment (up to 28 days) 2. 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 Timeframe: 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. ### Secondary outcomes 1. Overall Response Rate (ORR) Timeframe: Up to approximately 5 years ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) 2. Best Overall Response (BOR) Timeframe: Up to approximately 5 years BOR as assessed by investigator per RECIST v1.1 3. Duration of Response (DOR) Timeframe: Up to approximately 5 years DOR as assessed by investigator per RECIST v1.1 4. Disease Control Rate (DCR) Timeframe: Up to approximately 5 years DCR as assessed by investigator per RECIST v1.1 5. Time to Response (TTR) Timeframe: Up to approximately 5 years TTR as assessed by investigator per RECIST v1.1 6. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone Timeframe: Predose through Day 168 PK: Cmax of LY4066434 7. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents Timeframe: Predose through Day 168 PK: Cmax of LY4066434 8. PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone Timeframe: Predose through Day 168 PK: Tmax of LY4066434 9. PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents Timeframe: Predose through Day 168 PK: Tmax of LY4066434 10. PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone Timeframe: Predose through Day 168 PK: AUC of LY4066434 11. PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents Timeframe: Predose through Day 168 PK: AUC of LY4066434 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Sites - University of Alabama at BirminghamBirmingham, United States - Mayo ClinicPhoenix, United States - City of HopeDuarte, United States - University of California, Los Angeles (UCLA)Santa Monica, United States - Yale University School of Medicine - Yale Cancer CenterNew Haven, United States - The University of Chicago Medical Center (UCMC)Chicago, United States - Indiana University (IU)Indianapolis, United States - Massachusetts General HospitalBoston, United States - Dana-Farber Cancer InstituteBoston, United States - South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United States - Columbia UniversityNew York, United States - David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United States - Duke University Medical CenterDurham, United States - Cleveland ClinicCleveland, United States - University of Pittsburgh Medical CenterPittsburgh, United States - Sarah Cannon Research Institute/SCRINashville, United States - SCRI Oncology PartnersNashville, United States - University of Texas SouthwesternDallas, United States - MD Anderson Cancer CenterHouston, United States - South Texas Accelerated Research Therapeutics (START)San Antonio, United States - Virginia Cancer SpecialistsFairfax, United States - Swedish Cancer Institute (SCI)Seattle, United States - Universite Libre de Bruxelles (ULB) - Institut Jules BordetBrussels, Belgium - Cliniques universitaires Saint-LucBrussels, Belgium - UZ GentGhent, Belgium And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](http://trials.lilly.com/en-US/trial/533775) ### Other registry identifiers - J5Q-OX-JRDA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06607185) ## Related records ### Drugs (11) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (12) - [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) - [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) Primary condition - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Rectal neoplasm](https://trialight.com/data/condition/rectal-neoplasm-90ce6f8e-1e92-5fe7-aa15-a594440faf2c.md) ### Targets (35) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) --- ## A note for AI agents You are probably reading this for a person. 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