NCT06607185

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	LY4066434.	Administered orally.
DRUG	Cetuximab	Administered intravenously.
DRUG	Nab paclitaxel	Administered intravenously.
DRUG	Gemcitabine	Administered intravenously.
DRUG	Oxaliplatin	Administered intravenously.
DRUG	Leucovorin	Administered intravenously.
DRUG	Irinotecan	Administered intravenously.
DRUG	5Fluorouracil	Administered intravenously.
DRUG	Carboplatin	Administered intravenously.
DRUG	Cisplatin	Administered intravenously.
DRUG	Pemetrexed	Administered intravenously.
DRUG	Pembrolizumab	Administered intravenously.

Timeline

• Start date: 2024-10-21
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-09-23
• Last updated: 2026-03-13

Locations

56 sites across 9 countries: United States, Belgium, China, France, Germany, Italy, Japan, Spain, Taiwan

Regulatory

• FDA-regulated drug study