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Recruiting Phase 1 NCT06586515

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

Trial Parameters

Condition Pancreatic Ductal Adenocarcinoma
Sponsor Eli Lilly and Company
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 630
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-12
Completion 2029-03
Interventions
LY3962673CetuximabGemcitabine

Brief 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 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, fu

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