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MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
RECRUITINGPhase 1Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2024-09-12
Est. completion2029-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations25 sites
View on ClinicalTrials.gov →
NCT06586515
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions5
CancerColorectal CancerLung CancerNon Small Cell Lung CancerPancreatic Ductal Adenocarcinoma
Interventions8
Locations25 sites
City of Hope
University of California, Los Angeles (UCLA)
Sibley Memorial Hospital
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2024-09-12
Est. completion2029-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations25 sites
View on ClinicalTrials.gov →
NCT06586515