RECRUITING

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

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Conditions

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal CancerAdvanced Solid TumorMetastatic Solid TumorKRASKRAS mutationKRASG12CKRASG12DKRASG12VKRASG12SKRASG12AKRASG13DLY4066434Targeted therapyLung cancerPancreas cancerColon cancerRectal cancerOvarian cancerEndometrial cancerCholangiocarcinomaEsophageal cancerKRAS-mutant tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-21
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06607185

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
  2. * Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
  3. * Have measurable disease per RECIST 1.1
  4. * Have an ECOG performance status of ≤1
  5. * Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
  6. * Must be able to swallow tablets
  7. * Participants with asymptomatic or treated CNS disease may be eligible
  1. * Have known active CNS metastases and/or carcinomatous meningitis
  2. * 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
  3. * 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.
  4. * Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) and untreated HIV infection
  5. * Have other active malignancy unless in remission with life expectancy greater than 2 years.
  6. * Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  7. * Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
13176154559
ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35233-2028
United States
City of Hope National Medical Center
Duarte, California, 91010-0269
United States
UCLA
Santa Monica, California, 90404
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Memorial Sloan Kettering
New York, New York, 10021
United States
Columbia University
New York, New York, 10032
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9063
United States
MD Anderson
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229-3307
United States
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2030-01

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • KRAS
  • KRAS mutation
  • KRASG12C
  • KRASG12D
  • KRASG12V
  • KRASG12S
  • KRASG12A
  • KRASG13D
  • LY4066434
  • Targeted therapy
  • Lung cancer
  • Pancreas cancer
  • Colon cancer
  • Rectal cancer
  • Colorectal cancer
  • Ovarian cancer
  • Endometrial cancer
  • Cholangiocarcinoma
  • Esophageal cancer
  • KRAS-mutant tumor

Additional Relevant MeSH Terms

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