Status:
RECRUITING
A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
Lead Sponsor:
Jemincare
Conditions:
NSCLC (Advanced Non-small Cell Lung Cancer)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 chemotherap...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
- Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
- Measurable disease according to RECIST 1.1.
- An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Exclusion
- 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.
- 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).
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06946927
Start Date
June 6 2025
End Date
December 1 2027
Last Update
July 1 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080