MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Recruiting · NCT06586515 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 17 US states.
- City of Hope - Duarte, California, United States
- City of Hope - Duarte, California, United States
- University of California, Los Angeles (UCLA) - Santa Monica, California, United States
- University of California, Los Angeles (UCLA) - Santa Monica, California, United States
- Sarah Cannon Research Institute at HealthOne - Denver, Colorado, United States
- Sarah Cannon Research Institute at HealthOne - Denver, Colorado, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute - Orlando, Florida, United States
- Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute - Orlando, Florida, United States
- Emory University School of Medicine - Atlanta, Georgia, United States
- Emory University School of Medicine - Atlanta, Georgia, United States
- Community Health Network - Indianapolis, Indiana, United States
- Community Health Network - Indianapolis, Indiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, 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
- Barbara Ann Karmanos Cancer Institute - Detroit, Michigan, United States
- South Texas Accelerated Research Therapeutics (START) Midwest - Grand Rapids, 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
- 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
- Duke University Medical Center - Durham, North Carolina, United States
- University of Cincinnati (UC) - Cancer Institute - Cincinnati, Ohio, United States
- University of Cincinnati (UC) - Cancer Institute - Cincinnati, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center - Pittsburgh, Pennsylvania, 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
- 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
- MD Anderson Cancer Center - Houston, Texas, United States
- South Texas Accelerated Research Therapeutics (START) - San Antonio, Texas, United States
- South Texas Accelerated Research Therapeutics (START) - San Antonio, Texas, United States
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- University of Wisconsin - Carbone Cancer Center - Madison, Wisconsin, United States
- University of Wisconsin - Carbone Cancer Center - Madison, Wisconsin, United States
- 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) Barcelona- HM Nou Delfos - Barcelona, Spain
- Hospital Universitario Vall d'Hebron - Barcelona, Spain
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences - Beijing, China
- Beijing Cancer hospital - Beijing, China
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences - Beijing, China
- Beijing Cancer hospital - Beijing, China
- Charite Universitaetsmedizin Berlin - Berlin, Germany
- Charite Universitaetsmedizin Berlin - Berlin, Germany
Showing 60 of 104 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →