NCT06235983

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
11mo left

Started Feb 2024

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Feb 2024Apr 2027

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

January 24, 2024

Last Update Submit

April 17, 2025

Conditions

Advanced Solid Tumors

Keywords

PharmacokineticsSafety and TolerabilityChinese

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982

    PK: Cmax of LY3537982

    Predose approximately up to 18 weeks

  • PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982

    PK: AUC of LY3537982

    Predose approximately up to 18 weeks

Secondary Outcomes (3)

  • Objective Response Rate (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

  • Disease control rate (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

  • Progression-free survival (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

Study Arms (1)

LY3537982

EXPERIMENTAL

LY3537982 administered orally.

Drug: LY3537982

Interventions

LY3537982DRUG

Administered orally.

Also known as: Olomorasib
LY3537982

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jilin Cancer Hospital

Changchun, Jilin, 132000, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

February 29, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)