Refer to 7(5)
Conditions
Interventions
DRUG: LY4066434.
Administered orally.
DRUG: Cetuximab
Administered intravenously.
DRUG: Nab paclitaxel
Administered intravenously.
DRUG: Gemcitabine
Administered intravenously.
DRUG: Oxaliplat
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: 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 [Time Frame: 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. | — |
Countries
Belgium, China, France, Germany, Italy, Japan, Spain, Taiwan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed