drugset / Trial / NCT07339839

Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC

NCT07339839

NaSingle-groupOpen-labelTreatment

Summary

This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.

Timeline

Start
2026-03-01
Primary completion
2027-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Glecirasib Small molecule 600 mg
Subject Glecirasib Small molecule 800 mg
Subject Ivonescimab Monoclonal antibody 20 mg/kg Intravenous