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

June 26, 2025 updated by: Jemincare

A Phase Ib, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of JMKX001899 in Combination With Other Therapies in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: JMKX001899+IN10018
Drug: JMKX001899
JMKX001899 tablet administered orally daily.
Drug: IN10018
IN10018 tablet administered orally daily.
Experimental: Cohort B: JMKX001899+chemotherapy
Drug: JMKX001899
JMKX001899 tablet administered orally daily.
Drug: Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Drug: Carboplatin
IV infusion once every 3 weeks, 4 Cycles
Experimental: Cohort C: JMKX001899+IN10018+chemotherapy
Drug: JMKX001899
JMKX001899 tablet administered orally daily.
Drug: IN10018
IN10018 tablet administered orally daily.
Drug: Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Drug: Carboplatin
IV infusion once every 3 weeks, 4 Cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recommended Phase II dose (RP2D)
Time Frame: approximately 1 year
approximately 1 year
adverse events
Time Frame: Through study completion, approximately 2.5 years
Through study completion, approximately 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jemincare

Investigators

  • Principal Investigator: Yilong WU, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMKX1899-C101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NSCLC (Advanced Non-small Cell Lung Cancer)

Clinical Trials on JMKX001899

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe