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

RECRUITINGPhase 1Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2024-09-12
Est. completion2029-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations25 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions5

CancerColorectal CancerLung CancerNon Small Cell Lung CancerPancreatic Ductal Adenocarcinoma

Locations25 sites

City of Hope
Duarte, California, 91010
University of California, Los Angeles (UCLA)
Los Angeles, California, 90025
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, 32827

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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