drugset / Trial / NCT07339839
Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC
Phase 1/2
Not yet recruiting
42 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glecirasib | Small molecule | 600 mg | — |
| Subject | Glecirasib | Small molecule | 800 mg | — |
| Subject | Ivonescimab | Monoclonal antibody | 20 mg/kg | Intravenous |