MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

NCT06586515 · tracked via the Priya Life Science Ireland tracker

Sponsor

Eli Lilly and Company

Phase

Phase 1

Started

2024-09-12

Last updated

2026-08-24

Condition(s) studied

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal Cancer

Investigational drug(s) / intervention(s)

LY3962673CetuximabGemcitabinenab-paclitaxelOxaliplatinleucovorinIrinotecan5-fluorouracil

LY3962673: Administered orally.

Cetuximab: Administered intravenously.

Gemcitabine: Administered intravenously.

nab-paclitaxel: Administered intravenously.

Oxaliplatin: Administered intravenously.

leucovorin: Administered intravenously.

Irinotecan: Administered intravenously.

5-fluorouracil: Administered intravenously.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline through 5 years
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Phase 1a: Number of Participants with DLT — During the first 28-day cycle of LY3962673 treatment
Phase 1a: Number of Participants with DLT Equivalent Toxicities — During the first 28-day cycle of LY3962673 treatment
Phase 1b: Overall Response Rate (ORR) — Up to approximately 5 years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Phase 1b: Best Overall Response (BOR) — Up to approximately 5 years
BOR per investigator assessed RECIST 1.1
Phase 1b: Duration of Response (DOR) — Up to approximately 5 years
DOR per investigator assessed RECIST 1.1
Phase 1b: Time to Response (TTR) — Up to approximately 5 years
TTR per investigator assessed RECIST 1.1
Phase 1b: Disease Control Rate (DCR) — Up to approximately 5 years
DCR per investigator assessed RECIST 1.1

Trial sites (52)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
University of California, Los Angeles (UCLA)	Santa Monica	California	Recruiting
Sarah Cannon Research Institute at HealthOne	Denver	Colorado	Recruiting
Sibley Memorial Hospital	Washington D.C.	District of Columbia	Recruiting
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute	Orlando	Florida	Recruiting
Emory University School of Medicine	Atlanta	Georgia	Recruiting
Community Health Network	Indianapolis	Indiana	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Not Yet Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest	Grand Rapids	Michigan	Recruiting
New York University (NYU) Langone Medical Center	New York	New York	Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
University of Cincinnati (UC) - Cancer Institute	Cincinnati	Ohio	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center	Pittsburgh	Pennsylvania	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	Recruiting
USO - US Oncology Research Network	Nashville	Tennessee	Recruiting
Vanderbilt University School of Medicine	Nashville	Tennessee	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	Recruiting
University of Wisconsin - Carbone Cancer Center	Madison	Wisconsin	Recruiting
The Ottawa Hospital	Ottawa	Canada	Recruiting
Princess Margaret Hospital	Toronto	Canada	Recruiting
Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing	China	Not Yet Recruiting
Beijing Cancer hospital	Beijing	China	Not Yet Recruiting
Harbin Medical University Cancer Hospital	Harbin	China	Not Yet Recruiting
Fudan University Shanghai Cancer Center	Shanghai	China	Not Yet Recruiting
Centre Leon Berard	Lyon	France	Not Yet Recruiting
Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone	Marseille	France	Not Yet Recruiting
Oncopole Claudius Regaud	Toulouse	France	Not Yet Recruiting
Institut Gustave Roussy	Villejuif	France	Not Yet Recruiting
Charite Universitaetsmedizin Berlin	Berlin	Germany	Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Germany	Recruiting
Universitaetsklinikum Essen	Essen	Germany	Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen	München	Germany	Recruiting
START Dublin Early Phase Clinical Trials Unit	Dublin	Ireland	Recruiting

+ 12 more sites — see the full list on the official registry below.

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Other trials for the same condition

Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours Active, not recruiting

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) Recruiting

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients Recruiting

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06586515 on ClinicalTrials.gov ↗ ← All trials in Ireland