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Recruiting
NCT06586515
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Conditions: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 630
Sponsor: Eli Lilly and Company
Location: City of Hope Duarte California
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, 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.
Source: ClinicalTrials.gov (NCT06586515). StuddyBuddy aggregates publicly available trial information.