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

Launched by ELI LILLY AND COMPANY · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LY3962673 for patients with certain types of advanced cancer, specifically those with a KRAS G12D mutation. The main goal of the study is to evaluate how safe the treatment is and how well it works, both on its own and when combined with other chemotherapy drugs. The trial is open to individuals aged 65 and older who have been diagnosed with hard-to-treat cancers such as pancreatic cancer, non-small cell lung cancer, or colorectal cancer, and who have already received at least one prior chemotherapy treatment.

Participants in the trial will be closely monitored over the course of approximately five years to help researchers understand the treatment's effects. To be eligible, patients must have measurable cancer that hasn’t responded to other treatments and must have the specific KRAS G12D mutation found in their tumor. However, those with certain health issues, like serious heart problems or active infections, might not qualify. This trial represents an important step in exploring new options for patients dealing with challenging cancers.

Gender

ALL

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.