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MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT06586515 · Eli Lilly and Company
In plain English
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Official title
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
About this study
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
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
Enrollment target: 630 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-12
Estimated completion: 2029-03
Last updated: 2025-12-22
Interventions
Drug: LY3962673Drug: CetuximabDrug: GemcitabineDrug: nab-paclitaxelDrug: OxaliplatinDrug: leucovorinDrug: IrinotecanDrug: 5-fluorouracil
Primary outcomes
- • 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)
- • 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)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (52)
City of HopeRecruiting
Duarte, California, United States
University of California, Los Angeles (UCLA)Recruiting
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthOneRecruiting
Denver, Colorado, United States
Sibley Memorial HospitalRecruiting
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research InstituteRecruiting
Orlando, Florida, United States
Emory University School of MedicineRecruiting
Atlanta, Georgia, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
South Texas Accelerated Research Therapeutics (START) MidwestRecruiting
Grand Rapids, Michigan, United States
New York University (NYU) Langone Medical CenterRecruiting
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
University of Cincinnati (UC) - Cancer InstituteRecruiting
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
USO - US Oncology Research NetworkRecruiting
Nashville, Tennessee, United States
Vanderbilt University School of MedicineRecruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)Recruiting
San Antonio, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of Wisconsin - Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
The Ottawa HospitalRecruiting
Ottawa, Canada
Princess Margaret HospitalRecruiting
Toronto, Canada
Cancer Institute & Hospital, Chinese Academy of Medical SciencesNot Yet Recruiting
Beijing, China
Beijing Cancer hospitalNot Yet Recruiting
Beijing, China
Harbin Medical University Cancer HospitaNot Yet Recruiting
Harbin, China
Fudan University Cancer CenterNot Yet Recruiting
Shanghai, China
Centre Leon BerardNot Yet Recruiting
Lyon, France
Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La TimoneNot Yet Recruiting
Marseille, France
Oncopole Claudius RegaudNot Yet Recruiting
Toulouse, France
Institut Gustave RoussyNot Yet Recruiting
Villejuif, France
Charite Universitaetsmedizin BerlinRecruiting
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Klinikum der Ludwig-Maximilians-Universitaet MuenchenRecruiting
München, Germany
START Dublin Early Phase Clinical Trials UnitRecruiting
Dublin, Ireland
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliRecruiting
Naples, Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
Roma, Italy
Centro Ricerche Cliniche di Verona s.r.l.Recruiting
Verona, Italy
National Cancer Center Hospital EastRecruiting
Chiba, Japan
Kanagawa cancer centerRecruiting
Kanagawa, Japan
Aichi Cancer Center HospitalRecruiting
Nagoya, Japan
Kansai Medical University HospitalRecruiting
Osaka, Japan
National Cancer Center HospitalRecruiting
Tokyo, Japan
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou DelfosRecruiting
Barcelona, Spain
Hospital Universitario Vall d'HebronRecruiting
Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain