Status:

RECRUITING

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Pancreatic Ductal Adenocarcinoma

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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-m...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 12 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2029

Estimated Enrollment :

630 Patients enrolled

Trial Details

Trial ID

NCT06586515

Start Date

September 12 2024

End Date

March 1 2029

Last Update

December 22 2025

Active Locations (52)

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Page 1 of 13 (52 locations)

1

City of Hope

Duarte, California, United States, 91010

2

University of California, Los Angeles (UCLA)

Los Angeles, California, United States, 90025

3

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States, 80218

4

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States, 20016