MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Purpose
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.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Non-small Cell Lung Cancer
- Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Phase 1a/1b
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1a: LY3962673 Dose Escalation |
Escalating doses of LY3962673 administered orally. |
|
|
Experimental Phase 1b: LY3962673 Dose Expansion |
LY3962673 administered orally either alone or in combination with other chemotherapy agents. |
|
|
Experimental Experimental: Phase 1a: LY3962673 Monotherapy |
LY3962673 administered orally |
|
Recruiting Locations
Vanderbilt University School of Medicine
Nashville, Tennessee 37215
Nashville, Tennessee 37215
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com