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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Jieting Zhao
zhaojieting@jemincare.com
+86 13407649933
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 72
Treatments
Experimental: Cohort A: JMKX001899+IN10018
Experimental: Cohort B: JMKX001899+chemotherapy
Experimental: Cohort C: JMKX001899+IN10018+chemotherapy
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Leads: Jemincare

This content was sourced from clinicaltrials.gov

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