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

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Non-small Cell Lung Cancer; Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Cetuximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan; Drug: LY3962673; Drug: nab-paclitaxel; Drug: leucovorin; Drug: 5-fluorouracil

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Canada
  • Ottawa, Canada, K1H 8L6
    • Recruiting
    • The Ottawa Hospital
  • Toronto, Canada, M5G 2M9
    • Recruiting
    • Princess Margaret Hospital
• China
  • Beijing, China, 100142
    • Not yet recruiting
    • Beijing Cancer Hospital
    • Principal Investigator: Lin Shen
    • Contact: Phone Number: 86 010-88196929
  • Beijing, China, 100021
    • Not yet recruiting
    • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
  • Harbin, China, 150081
    • Not yet recruiting
    • Harbin Medical University Cancer Hospita
    • Principal Investigator: Yanqiao Zhang
  • Shanghai, China, 200032
    • Not yet recruiting
    • Fudan University Cancer Center
    • Principal Investigator: Xianjun Yu
    • Contact: Phone Number: 86 021-65675209
• France
  • Lyon, France, 69373
    • Not yet recruiting
    • Centre Leon Berard
  • Marseille, France, 13005
    • Not yet recruiting
    • Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone
    • Principal Investigator: PASCALE TOMASINI
  • Toulouse, France, 31059
    • Not yet recruiting
    • Oncopole Claudius Regaud
    • Principal Investigator: Iphigenie Korakis
  • Villejuif, France, 94805
    • Not yet recruiting
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitaetsmedizin Berlin
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Carl Gustav Carus Dresden
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
• Ireland
  • Dublin, Ireland, D07 R2WY
    • Recruiting
    • START Dublin Early Phase Clinical Trials Unit
    • Principal Investigator: Austin Duffy
• Italy
  • Naples, Italy, 80138
    • Recruiting
    • Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
  • Roma, Italy, 00168
    • Recruiting
    • UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
    • Principal Investigator: Gennaro Daniele
    • Contact: Phone Number: +390630153446
  • Verona, Italy, 37134
    • Recruiting
    • Centro Ricerche Cliniche di Verona S.r.l.
    • Principal Investigator: Davide Melisi
• Japan
  • Chiba, Japan, 277-8577
    • Recruiting
    • National Cancer Center Hospital East
  • Kanagawa, Japan, 241-8515
    • Recruiting
    • Kanagawa Cancer Center
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Makoto Ueno
  • Nagoya, Japan, 464-8681
    • Recruiting
    • Aichi Cancer Center Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Yutaka Fujiwara
  • Osaka, Japan, 573-1191
    • Recruiting
    • Kansai Medical University Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Toshio Shimizu
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Takafumi Koyama
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron
    • Principal Investigator: Elena Garralda Cabanas
    • Contact: Phone Number: +34 932543450
  • Barcelona, Spain, 08023
    • Recruiting
    • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
    • Principal Investigator: Tatiana Hernandez Guerrero
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Principal Investigator: Rocio Garcia Carbonero
    • Contact: Phone Number: +34 913908922
  • Madrid, Spain, 28040
    • Recruiting
    • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
    • Principal Investigator: Victor Moreno
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Principal Investigator: Aditya Shreenivas
      • Contact: Phone Number: 626-613-5411
    • Santa Monica, California, United States, 90404
      • Recruiting
      • University of California, Los Angeles (UCLA)
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Sarah Cannon Research Institute at HealthONE
      • Principal Investigator: Jason Henry
      • Contact: Phone Number: (720)-754-2610
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
      • Principal Investigator: Cesar Perez
      • Contact: Phone Number: (407) 735-5695
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School Of Medicine
      • Principal Investigator: Olatunji Alese
      • Contact: Phone Number: 404-778-3932
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Community Health Network
      • Principal Investigator: Natraj Ammakkanavar
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Brandon Huffman
      • Contact: Phone Number: 617-632-5460
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Aparna Parikh
      • Contact: Phone Number: 617-726-1718
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Barbara Ann Karmanos Cancer Institute
      • Principal Investigator: Mohammed Najeeb Al Hallak
      • Contact: Phone Number: 313-576-9806
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START) Midwest
      • Principal Investigator: Nehal Lakhani
      • Contact: Phone Number: 616-389-1652
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
      • Principal Investigator: Anupriya Singhal
    • New York, New York, United States, 10016
      • Recruiting
      • New York University (NYU) Langone Medical Center
      • Principal Investigator: Paul Oberstein
      • Contact: Phone Number: 212-731-6363
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Principal Investigator: John Strickler
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati (UC) - Cancer Institute
      • Principal Investigator: Davendra Sohal
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Wen Wee Ma
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
      • Principal Investigator: Ibrahim Sahin
      • Contact: Phone Number: 412-647-2811
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
      • Principal Investigator: Vivek Subbiah
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Vanderbilt University School of Medicine
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • USO - US Oncology Research Network
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: David Hong
      • Contact: Phone Number: 713-563-2169
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START)
      • Principal Investigator: Amita Patnaik
      • Contact: Phone Number: 210-593-5260
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute
      • Principal Investigator: Ignacio Garrido Laguna
      • Contact: Phone Number: 801-587-4652
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
      • Principal Investigator: Elena Chiorean
      • Contact: Phone Number: 206-288-7370
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin - Carbone Cancer Center
      • Contact: Dustin Deming

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Cetuximab; Administered intravenously.; Drug: Gemcitabine; Administered intravenously.; Drug: Oxaliplatin; Administered intravenously.; Drug: Irinotecan; Administered intravenously.; Drug: LY3962673; Administered orally.; Drug: nab-paclitaxel; Administered intravenously.; Drug: leucovorin; Administered intravenously.; Drug: 5-fluorouracil; Administered intravenously.
Experimental: Experimental: Phase 1a: LY3962673 Monotherapy; LY3962673 administered orally	Drug: LY3962673; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.	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
Phase 1b: Overall Response Rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to approximately 5 years
Phase 1b: Best Overall Response (BOR)	BOR per investigator assessed RECIST 1.1	Up to approximately 5 years
Phase 1b: Duration of Response (DOR)	DOR per investigator assessed RECIST 1.1	Up to approximately 5 years
Phase 1b: Time to Response (TTR)	TTR per investigator assessed RECIST 1.1	Up to approximately 5 years
Phase 1b: Disease Control Rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Overall Response Rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to approximately 5 years
Best Overall Response (BOR)	BOR per investigator assessed RECIST 1.1	Up to approximately 5 years
Duration of Response (DOR)	DOR per investigator assessed RECIST 1.1	Up to approximately 5 years
Time to Response (TTR)	TTR per investigator assessed RECIST 1.1	Up to approximately 5 years
Disease Control Rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to approximately 5 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673	PK: Cmax of LY3962673	Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY3962673	PK: Tmax of LY3962673	Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673	PK: AUC of LY3962673	Predose through Day 168

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Call 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gemcitabine; Cetuximab; Irinotecan; nab-paclitaxel; KRAS; Oxaliplatin; Leucovorin; 5-fluorouracil; KRAS G12D; LY3962673
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Oxaliplatin; Irinotecan; Cetuximab; Gemcitabine; Fluorouracil; Leucovorin; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: 27189; J5J-OX-JZZA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No