RECRUITING

A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

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Conditions

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal CancerKRAS G12DKRASLY3962673Cetuximabnab-paclitaxelGemcitabineOxaliplatinLeucovorinIrinotecan5-fluorouracil

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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 this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Official Title

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Quick Facts

Study Start:2024-09-12
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06586515

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 Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  2. * Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
  3. * Have an ECOG performance status of ≤ 1
  4. * Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
  5. * 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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
  3. * Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
  4. * Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
  5. * Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
  6. * Have other active malignancy unless in remission with life expectancy greater than (\>) 2 years.

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)

UCLA
Santa Monica, California, 90404
United States
City of Hope Medical Group
South Pasadena, California, 91030
United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
United States
Florida Cancer Specialists Lake Nona Drug Development Unit
Orlando, Florida, 32827
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Community Health Network
Indianapolis, Indiana, 46250
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START San Antonio
San Antonio, Texas, 78229
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Washington Medical Center
Seattle, Washington, 98109
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
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 Date2024-09-12
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-09-12
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12D
  • KRAS
  • LY3962673
  • Cetuximab
  • nab-paclitaxel
  • Gemcitabine
  • Oxaliplatin
  • Leucovorin
  • Irinotecan
  • 5-fluorouracil

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma
  • Non-small Cell Lung Cancer
  • Colorectal Cancer