Vanderbilt Clinical Trials

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.	Drug: LY3962673 Administered orally.
Experimental Phase 1b: LY3962673 Dose Expansion	LY3962673 administered orally either alone or in combination with other chemotherapy agents.	Drug: LY3962673 Administered orally. Drug: Cetuximab Administered intravenously. Drug: Gemcitabine Administered intravenously. Drug: nab-paclitaxel Administered intravenously. Drug: Oxaliplatin Administered intravenously. Drug: leucovorin Administered intravenously. Drug: Irinotecan Administered intravenously. Drug: 5-fluorouracil Administered intravenously.
Experimental Experimental: Phase 1a: LY3962673 Monotherapy	LY3962673 administered orally	Drug: LY3962673 Administered orally.

Recruiting Locations

Vanderbilt University School of Medicine
Nashville 4644585, Tennessee 4662168 37215

More Details

Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.