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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 630 · Started: Sep 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06586515

Locations in the U.S.

CaliforniaCity of Hope, Duarte
University of California, Los Angeles (UCLA), Santa Monica
ColoradoSarah Cannon Research Institute at HealthOne, Denver
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaFlorida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute, Orlando
GeorgiaEmory University School of Medicine, Atlanta
IndianaCommunity Health Network, Indianapolis
MassachusettsDana-Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston (Not yet recruiting)
MichiganBarbara Ann Karmanos Cancer Institute, Detroit
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids
New YorkDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York
New York University (NYU) Langone Medical Center, New York
North CarolinaDuke University Medical Center, Durham
OhioUniversity of Cincinnati (UC) - Cancer Institute, Cincinnati
Cleveland Clinic, Cleveland
PennsylvaniaUniversity of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh
TennesseeSarah Cannon Research Institute, Nashville
USO - US Oncology Research Network, Nashville
Vanderbilt University School of Medicine, Nashville
TexasMD Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics (START), San Antonio
UtahHuntsman Cancer Institute, Salt Lake City
WashingtonFred Hutchinson Cancer Center, Seattle
WisconsinUniversity of Wisconsin - Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.