MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
- Conditions
- Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal Cancer
- Interventions
- Registration Number
- NCT06586515
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 540
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a: LY3962673 Dose Escalation LY3962673 Escalating doses of LY3962673 administered orally. Phase 1b: LY3962673 Dose Expansion LY3962673 LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion Cetuximab LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion Gemcitabine LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion nab-paclitaxel LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion Oxaliplatin LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion leucovorin LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion Irinotecan LY3962673 administered orally either alone or in combination with other chemotherapy agents. Phase 1b: LY3962673 Dose Expansion 5-fluorouracil LY3962673 administered orally either alone or in combination with other chemotherapy agents. Experimental: Phase 1a: LY3962673 Monotherapy LY3962673 LY3962673 administered orally
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Phase 1a: 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)
Best Overall Response (BOR) Up to approximately 5 years BOR per investigator assessed RECIST 1.1
Duration of Response (DOR) Up to approximately 5 years DOR per investigator assessed RECIST 1.1
Time to Response (TTR) Up to approximately 5 years TTR per investigator assessed RECIST 1.1
Disease Control Rate (DCR) Up to approximately 5 years DCR per investigator assessed RECIST 1.1
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673 Predose through Day 168 PK: Cmax of LY3962673
PK: Time to Maximum Concentration (Tmax) of LY3962673 Predose through Day 168 PK: Tmax of LY3962673
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673 Predose through Day 168 PK: AUC of LY3962673
Trial Locations
- Locations (48)
City of Hope
🇺🇸Duarte, California, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Sarah Cannon Research Institute at HealthOne
🇺🇸Denver, Colorado, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
🇺🇸Orlando, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
South Texas Accelerated Research Therapeutics (START) Midwest
🇺🇸Grand Rapids, Michigan, United States
New York University (NYU) Langone Medical Center
🇺🇸New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati (UC) - Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
USO - US Oncology Research Network
🇺🇸Nashville, Tennessee, United States
Vanderbilt University School of Medicine
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
University of Wisconsin - Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Centre Leon Berard
🇫🇷Lyon, France
Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone
🇫🇷Marseille, France
Oncopole Claudius Regaud
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif cedex, France
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
🇩🇪Munchen, Germany
START Dublin Early Phase Clinical Trials Unit
🇮🇪Dublin, Ireland
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Centro Ricerche Cliniche di Verona s.r.l.
🇮🇹Verona, Italy
Kanagawa cancer center
🇯🇵Kanagawa, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya, Japan
Kansai Medical University Hospital
🇯🇵Osaka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain