Clinical Research Directory
Browse clinical research sites, groups, and studies.
This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Summary
This is an open-label, multicenter Phase Ib/II clinical study evaluating GFH276 in combination with tislelizumab plus pemetrexed/platinum based regimen as first-line therapy in participants with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring RAS mutation or KRAS amplification.
Official title: A Phase Ib/II, Multicenter, Open-Label Study To Evaluate Safety, Efficacy And Pharmacokinetics Of GFH276 In Combination With Tislelizumab, Pemetrexed And Platinum (Carboplatin Or Cisplatin) As First-Line Therapy In Participants With Locally Advanced Or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Harboring RAS Mutation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-11
Completion Date
2028-12
Last Updated
2026-09-29
Healthy Volunteers
No
Interventions
GFH276
Oral GFH276, administered at specified dose on schedule.
with or without Tislelizumab
Tislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab
Pemetrexed
Pemetrexed 500 mg/m², intravenous infusion, once every 3 weeks.
Cisplatin
Cisplatin 75 mg/m², intravenous infusion, once every 3 weeks.
Carboplatin
Carboplatin at AUC=5, intravenous infusion, once every 3 weeks.