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

Recruiting now · Phase 1

Conditions studied: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT06586515

Run by

Eli Lilly and Company

People needed

630

Starts

2024-09-12

Expected to finish

2029-03-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States (enrolling)
• University of California, Los Angeles (UCLA) — Santa Monica, California, United States (enrolling)
• Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute — Orlando, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• Community Health Network — Indianapolis, Indiana, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (enrolling)
• New York University (NYU) Langone Medical Center — New York, New York, United States (enrolling)
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• University of Cincinnati (UC) - Cancer Institute — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• USO - US Oncology Research Network — Nashville, Tennessee, United States (enrolling)
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (enrolling)
• Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
• The Ottawa Hospital — Ottawa, Canada (enrolling)

Full record on ClinicalTrials.gov

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