MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
MOONRAY-01, A Study 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.
Colon,
Esophageal,
Gastric/Gastroesophageal,
Gastrointestinal,
Lung,
Non Small Cell,
Pancreatic,
Phase I,
Rectal,
Uterine
Phase I
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
5FU bolus,
5FU continuous infusion,
Cetuximab,
Gemcitabine,
Irinotecan,
LY3962673,
Leucovorin,
Nab-Paclitaxel,
Oxaliplatin
Cardin, Dana
International
Vanderbilt University
07-23-2025
Eligibility
18 Years and older
ALL
false
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 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 evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
Have an ECOG performance status of 1
Have an ECOG performance status of 1
Must have received 1 prior line of systemic chemotherapy for advanced or metastatic disease
Must have received 1 prior line of systemic chemotherapy for advanced or metastatic disease
Participants with asymptomatic or treated CNS disease may be eligible.
Participants with asymptomatic or treated CNS disease may be eligible.
Exclusion Criteria:
Have known active CNS metastases and/or carcinomatous meningitis.
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 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 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 active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
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.
Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.
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 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 evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
Have an ECOG performance status of 1
Have an ECOG performance status of 1
Must have received 1 prior line of systemic chemotherapy for advanced or metastatic disease
Must have received 1 prior line of systemic chemotherapy for advanced or metastatic disease
Participants with asymptomatic or treated CNS disease may be eligible.
Participants with asymptomatic or treated CNS disease may be eligible.
Exclusion Criteria:
Have known active CNS metastases and/or carcinomatous meningitis.
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 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 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 active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
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.
Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.
