A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
Recruiting · NCT06946927 · Interventional (participants receive a specific treatment) · Lead sponsor: Jemincare
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Guangdong Provincial People's Hospital - Guangzhou, Guangdong, China