Summary of Clinical Use

Tagitanlimab (KL-A167) is a clinical candidate therapeutic for the treament of advanced solid tumours and lymphoma. It is being tested as a monotherapy and in combination with other anti-tumour agents. The Chinese drug regulator (NMPA) approved tagitanlimab (Cotelet®)- combined with cisplatin and gemcitabine- in late 2024, to treat recurrent/metastatic nasopharyngeal cancer.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT05445908	SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer	Phase 2 Interventional	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
NCT05351788	SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.	Phase 2 Interventional	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
NCT05294172	KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma	Phase 3 Interventional	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
NCT03580564	An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma	Phase 2 Interventional	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
NCT03848286	KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma	Phase 2 Interventional	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.		1