MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LY3962673
- Cetuximab
- Gemcitabine
- nab-paclitaxel
- Oxaliplatin
- leucovorin
- Irinotecan
- 5-fluorouracil
Treatment groups
630 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov