drugset / Trial / NCT07854509

A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure

NCT07854509 ↗

Phase 2 Not yet recruiting 110 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.

Timeline

Start
2026-10-15
Primary completion
2027-12-30
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SKB118 Unknown 10 mg/kg Intravenous
Subject SKB118 Unknown 20 mg/kg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous