A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors (NCT06235983) | Clinical Trial Compass
CompletedPhase 1
A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors
China12 participantsStarted 2024-02-29
Plain-language summary
This is an open-label, single-arm, multicenter, Phase 1 study of LY3537982 as monotherapy in Chinese participants with KRAS G12C-mutant advanced solid tumors. The main purpose of this study is to determine how much of LY3537982 gets into the bloodstream and how long it takes the body to eliminate it in Chinese participants. The safety, tolerability and preliminary efficacy of LY3537982 will also be evaluated. Approximately 12 patients will be enrolled in this study.
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:
* \- Native Chinese participants must be of an acceptable age to provide informed consent.
* Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1).
* Have disease with evidence of KRAS G12C mutation
* Have a histologically or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and must be appropriate candidates for study treatment.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have adequate laboratory parameters.
* Must be able to swallow capsules or tablets.
* Estimated life expectancy ≥12 weeks
Exclusion Criteria:
* Have disease suitable for local therapy administered with curative intent.
* Have an active fungal, bacterial, and/or active untreated viral infection,
* Have a serious pre-existing medical condition(s) that would preclude participation in this study.
* Have a serious cardiac condition.
* Have untreated active symptomatic central neural system (CNS) malignancy or metastasis and/or carcinomatous meningitis.
* Have received prior treatment with any KRAS G12C small molecule inhibitor.
* Females who are pregnant or lactating.
* Have a known allergic reaction against any of the components of the study drug
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
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
Timeframe: Predose approximately up to 18 weeks
2
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982