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

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
13176154559
clinical_inquiry_hub@lilly.com