A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Condition
Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35233-2028

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010-0269

Santa Monica

UCLA, Santa Monica, California, United States, 90404

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114-2696

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

New York

Memorial Sloan Kettering, New York, New York, United States, 10021

New York

Columbia University, New York, New York, United States, 10032

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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, 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) and 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2030-01