A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235983
• Other study ID #: 18737
• Secondary ID: J3M-MC-JZQC
• Status: Recruiting
• Phase: Phase 1
• Start date: February 29, 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• LY3537982
Administered orally.

Locations

Country	Name	City	State
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982	PK: Cmax of LY3537982	Predose approximately up to 18 weeks
Primary	PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982	PK: AUC of LY3537982	Predose approximately up to 18 weeks
Secondary	Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	ORR: ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	First dose on day 1 approximately up to 3 years
Secondary	Disease control rate (DCR): DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	DCR: DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	First dose on day 1 approximately up to 3 years
Secondary	Progression-free survival (PFS): PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	PFS: PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).	First dose on day 1 approximately up to 3 years