A Phase 1 interventional study of LY4066434. and Cetuximab in Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer and Colorectal Cancer, sponsored by Eli Lilly and Company. Active, not recruiting at 45 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 750 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Escalating doses of LY4066434 administered orally.
Drug: LY4066434.
LY4066434 administered orally either alone or with another investigational agent.
Drug: LY4066434. · Drug: Cetuximab · Drug: Nab paclitaxel · Drug: Gemcitabine · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Irinotecan · Drug: 5Fluorouracil · Drug: Carboplatin · Drug: Cisplatin · Drug: Pemetrexed · Drug: Pembrolizumab
Administered orally.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Also known as: Folinic Acid
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
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
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Time frame: Up to approximately 5 years
Best Overall Response (BOR)
BOR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Duration of Response (DOR)
DOR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Disease Control Rate (DCR)
DCR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Time to Response (TTR)
TTR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone
PK: Cmax of LY4066434
Time frame: Predose through Day 168
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents
PK: Cmax of LY4066434
Time frame: Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone
PK: Tmax of LY4066434
Time frame: Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents
PK: Tmax of LY4066434
Time frame: Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone
PK: AUC of LY4066434
Time frame: Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents
PK: AUC of LY4066434
Time frame: Predose through Day 168
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Eli Lilly and Company