MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors (NCT06586515) | Clinical Trial Compass
RecruitingPhase 1
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
United States, Canada, China630 participantsStarted 2024-09-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Baseline through 5 years
2
Phase 1a: Number of Participants with DLT
Timeframe: During the first 28-day cycle of LY3962673 treatment
3
Phase 1a: Number of Participants with DLT Equivalent Toxicities
Timeframe: During the first 28-day cycle of LY3962673 treatment
4
Phase 1b: Overall Response Rate (ORR)
Timeframe: Up to approximately 5 years
5
Phase 1b: Best Overall Response (BOR)
Timeframe: Up to approximately 5 years
6
Phase 1b: Duration of Response (DOR)
Timeframe: Up to approximately 5 years
7
Phase 1b: Time to Response (TTR)
Timeframe: Up to approximately 5 years
Trial details
NCT IDNCT06586515
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-03
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or