MOONRAY-01, A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors
Trial Description
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 Requirements
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.