SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

Phase 2 Recruiting 110 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.

Timeline

Start: 2022-05-20
Primary completion: 2026-08
Completion: 2026-12

Publications

Hong S, Wang Q, Cheng Y, Luo Y, Qu X, Zhu H, Ding Z, Li X, Wu L, Wang Y, Hu S, Wang E, Liu A, Sun Y, Fan Y, Ye F, Lu K, Fang J, Shen Y, Jin X, Ge J, Zhang L, Fang W. First-line sacituzumab tirumotecan with tagitanlimab in advanced non-small-cell lung cancer: a phase 2 trial. Nat Med. 2025 Nov;31(11):3654-3661. doi: 10.1038/s41591-025-03883-5. Epub 2025 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	KL-A167	Unknown	1200 mg	Intravenous
Subject	Sacituzumab Tirumotecan	Other / unclassified	5 mg/kg	Intravenous

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

Summary

Timeline

Publications

Drugs

Indications