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

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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06946927

Enrollment

Registered

2025-04-27

Start date

2025-06-06

Completion date

2027-12-31

Last updated

2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Brief summary

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.

Interventions

DRUGJMKX001899

JMKX001899 tablet administered orally daily.

DRUGIN10018

IN10018 tablet administered orally daily.

DRUGChemotherapy: Pemetrexed

IV infusion once every 3 weeks

DRUGCarboplatin

IV infusion once every 3 weeks, 4 Cycles

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactJieting Zhao

zhaojieting@jemincare.com+86 13407649933

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026