Title
MOONRAY-01, A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors

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

Objective
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.

Treatment Trial J5J-OX-JZZA (JZZA) is a Phase 1a/1b multicenter, open-label trial to evaluate the safety, tolerability, and efficacy of oral LY3962673 as monotherapy and as part of relevant standard-ofcare combination therapy in participants with KRAS G12D-mutant advanced solid tumor types including, but not limited to PDAC, CRC, and non-small cell lung cancer (NSCLC)

Key Eligibility 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
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.

Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital