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.

Phase 1/2 Not yet recruiting 84 enrolled Genfleet Therapeutics (Shanghai) Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2026-11
Primary completion: 2027-12
Completion: 2028-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GFH276	Unknown	—	Oral
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

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.

Summary

Timeline

Drugs

Indications