A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation

NCT ID: NCT06946927

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-06

Study Completion Date

2027-12-31

Brief Summary

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This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.

Detailed Description

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Conditions

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NSCLC (Advanced Non-small Cell Lung Cancer)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: JMKX001899+IN10018

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

JMKX001899 tablet administered orally daily.

IN10018

Intervention Type DRUG

IN10018 tablet administered orally daily.

Cohort B: JMKX001899+chemotherapy

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

JMKX001899 tablet administered orally daily.

Chemotherapy: Pemetrexed

Intervention Type DRUG

IV infusion once every 3 weeks

Carboplatin

Intervention Type DRUG

IV infusion once every 3 weeks, 4 Cycles

Cohort C: JMKX001899+IN10018+chemotherapy

Group Type EXPERIMENTAL

JMKX001899

Intervention Type DRUG

JMKX001899 tablet administered orally daily.

IN10018

Intervention Type DRUG

IN10018 tablet administered orally daily.

Chemotherapy: Pemetrexed

Intervention Type DRUG

IV infusion once every 3 weeks

Carboplatin

Intervention Type DRUG

IV infusion once every 3 weeks, 4 Cycles

Interventions

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JMKX001899

JMKX001899 tablet administered orally daily.

Intervention Type DRUG

IN10018

IN10018 tablet administered orally daily.

Intervention Type DRUG

Chemotherapy: Pemetrexed

IV infusion once every 3 weeks

Intervention Type DRUG

Carboplatin

IV infusion once every 3 weeks, 4 Cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
2. Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
3. Measurable disease according to RECIST 1.1.
4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
5. Adequate organ function.

Exclusion Criteria

1. Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
2. Prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jemincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yilong Wu

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jieting Zhao

Role: CONTACT

+86 13407649933

Facility Contacts

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Yilong Wu

Role: primary

020-83525210

Other Identifiers

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JMKX1899-C101

Identifier Type: -

Identifier Source: org_study_id

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