NCT04956640

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Detailed description

This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors. This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Endometrial Neoplasms
• Ovarian Neoplasms
• Pancreatic Neoplasms
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
DRUG	LY3537982	Oral
DRUG	Pembrolizumab	Intravenous
DRUG	Cetuximab	Intravenous
DRUG	Pemetrexed	Intravenous
DRUG	Cisplatin	Intravenous
DRUG	Carboplatin	Intravenous

Timeline

• Start date: 2021-07-19
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2021-07-09
• Last updated: 2025-09-25

Locations

49 sites across 6 countries: United States, Australia, Canada, France, Japan, South Korea

Regulatory

• FDA-regulated drug study