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

Recruiting
18 years of age
Both
Phase 1

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Overview

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 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.

Study details

Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer

NCT06586515

Eli Lilly and Company

25 April 2025

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