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
Eli Lilly and Company
630 participants
Sep 12, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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.
Interventions
Administered orally.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Locations(52)
View Full Details on ClinicalTrials.gov
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NCT06586515