MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. - Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA - Have an ECOG performance status of ≤ 1 - Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease - Participants with asymptomatic or treated CNS disease may be eligible.

Exclusion Criteria

  • Have known active CNS metastases and/or carcinomatous meningitis. - Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1. - Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction. - Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. - Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV). - Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1a/1b
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1a: LY3962673 Dose Escalation 		Escalating doses of LY3962673 administered orally.
  • Drug: LY3962673
    Administered orally.
Experimental
Phase 1b: LY3962673 Dose Expansion 		LY3962673 administered orally either alone or in combination with other chemotherapy agents.
  • Drug: LY3962673
    Administered orally.
  • Drug: Cetuximab
    Administered intravenously.
  • Drug: Gemcitabine
    Administered intravenously.
  • Drug: nab-paclitaxel
    Administered intravenously.
  • Drug: Oxaliplatin
    Administered intravenously.
  • Drug: leucovorin
    Administered intravenously.
  • Drug: Irinotecan
    Administered intravenously.
  • Drug: 5-fluorouracil
    Administered intravenously.
Experimental
Experimental: Phase 1a: LY3962673 Monotherapy 		LY3962673 administered orally
  • Drug: LY3962673
    Administered orally.

Recruiting Locations

City of Hope
Duarte 5344147, California 5332921 91010

University of California, Los Angeles (UCLA)
Los Angeles 5368361, California 5332921 90025

Sarah Cannon Research Institute at HealthOne
Denver 5419384, Colorado 5417618 80218

Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando 4167147, Florida 4155751 32827

Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322

Community Health Network
Indianapolis 4259418, Indiana 4921868 46250

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Barbara Ann Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids 4994358, Michigan 5001836 49546

New York University (NYU) Langone Medical Center
New York 5128581, New York 5128638 10016

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

University of Cincinnati (UC) - Cancer Institute
Cincinnati 4508722, Ohio 5165418 45267

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232

Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203

USO - US Oncology Research Network
Nashville 4644585, Tennessee 4662168 37203

Vanderbilt University School of Medicine
Nashville 4644585, Tennessee 4662168 37215

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

South Texas Accelerated Research Therapeutics (START)
San Antonio 4726206, Texas 4736286 78229

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

University of Wisconsin - Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792

More Details

NCT ID
NCT06586515
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center