Clinical trial NCT06235983: A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors
Official title: An Open-label, Single-arm, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Antitumor Activity of LY3537982 in Chinese Patients With KRAS G12C-Mutant Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Pharmacokinetics
Safety and Tolerability
Chinese
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
timeFrame: Predose approximately up to 18 weeks
measure: PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
timeFrame: Predose approximately up to 18 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
timeFrame: First dose on day 1 approximately up to 3 years
measure: Disease control rate (DCR): DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
timeFrame: First dose on day 1 approximately up to 3 years
measure: Progression-free survival (PFS): PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
timeFrame: First dose on day 1 approximately up to 3 years
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: