Advanced Solid TumorsPhase 1NCT06235983
A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors
A Phase 1 study testing LY3537982 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 3 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- LY3537982
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesChina
- Study dates
- 29 Feb 2024to 30 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jilin Cancer Hospital
Changchun, Jilin, 132000
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
About this study
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
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- LY3537982
- Keywords
- Pharmacokinetics, Safety and Tolerability, Chinese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537982Drug
Also called Olomorasib
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3537982 | Experimental | LY3537982 administered orally. Receives: Drug: LY3537982 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
PK: Cmax of LY3537982
Measured: Predose approximately up to 18 weeks
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
PK: AUC of LY3537982
Measured: 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).
ORR: ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Measured: 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).
DCR: DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Measured: 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).
PFS: PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Measured: First dose on day 1 approximately up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Feb 2024
- Primary completion2 Jul 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235983
- Sponsor's protocol ID
- 18737
- Other IDs
- J3M-MC-JZQC
- Status last verified
- May 2026
- First submitted
- 24 Jan 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06235983
- Acronym / sponsor ID
- 18737
- Conditions
- Advanced Solid Tumors
- Keywords
- Pharmacokinetics, Safety and Tolerability, Chinese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3537982 | Experimental | Drug: LY3537982LY3537982 administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3537982Also: OlomorasibAdministered orally. | Drug | LY3537982 |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982
Time frame: Predose approximately up to 18 weeks
PK: Cmax of LY3537982
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3537982
Time frame: Predose approximately up to 18 weeks
PK: AUC of LY3537982
3 secondary outcomes
Objective Response Rate (ORR): ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).
Time frame: 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).
Time frame: 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).
Time frame: First dose on day 1 approximately up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3537982 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3537982 (time frame: Predose approximately up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.