A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Cancer

In brief

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

Key facts

Study ID

NCT04165031

Run by

Eli Lilly and Company

People needed

5

Starts

2019-11-28

Expected to finish

2020-10-30

Last updated by the study team

2021-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
• For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
• Participants must be willing to use highly effective birth control
• Participants must have adequate organ function
• Participants must be able to swallow capsules

You may not qualify if…

• Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
• Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
• Participants must not have cancer of the central nervous system that is not stable
• Participants must not be pregnant or breastfeeding
• Participants must not use herbal supplements

Where it is running

• Indiana Univ Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Memorial Sloan Kettering Cancer Center — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• St Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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