RECRUITINGPhase 1INTERVENTIONAL
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Have known active cancer that has spread to the brain 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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.
Locations (20)
City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Community Health Network
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
New York University (NYU) Langone Medical Center
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati (UC) - Cancer Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
USO - US Oncology Research Network
Nashville, Tennessee, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States