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MOONRAY-01: A Study of LY3962673 for KRAS G12D-Mutant Solid Tumors

This study, MOONRAY-01, is testing a new drug called LY3962673, alone or with other chemotherapy drugs like Cetuximab, Gemcitabine, nab-paclitaxel, or Oxaliplatin. It's for people with advanced solid tumors, including pancreatic, lung, or colorectal cancer, that have a specific genetic change called a KRAS G12D mutation. The main goals are to see how safe the treatments are and if they can shrink tumors. You must be 18 or older, have measurable cancer, and have the KRAS G12D mutation. The study plans to enroll 630 participants and is expected to last about 5 years. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 630 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events from the start of treatment through 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06586515

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eli Lilly and Company
~630 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY3962673CetuximabGemcitabinenab-paclitaxelOxaliplatinleucovorin

At a glance

Recruiting sites
43 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline through 5 years
+7 more outcomes measured

Conditions

Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

52 sites across 25 states
Japan5
China4
France4
Germany4
Spain4
Tennessee3
Italy3
California2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 AdministrationBaseline 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 DLTDuring the first 28-day cycle of LY3962673 treatment
  • Phase 1a: Number of Participants with DLT Equivalent ToxicitiesDuring 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