KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

Phase 1 Completed 36 enrolled Kyowa Kirin, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to subjects with locally advanced or metastatic solid tumors.

Timeline

Start: 2016-08
Primary completion: 2019-12-15
Completion: 2019-12-15

Publications

Yap TA, Rixe O, Baldini C, Brown-Glaberman U, Efuni S, Hong DS, Massard C, Muzaffar J, Varga A, Yilmaz E, Ikawa Y, Shiue LH, Liu Y, Hruska MW, Zhao H, Tokunaga A, Sahebjam S. First-in-human phase 1 study of KHK2455 monotherapy and in combination with mogamulizumab in patients with advanced solid tumors. Cancer. 2025 Jul 1;131(13):e35939. doi: 10.1002/cncr.35939.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KHK2455	Unknown	0.3 mg	Oral
Subject	KHK2455	Unknown	1 mg	Oral
Subject	KHK2455	Unknown	3 mg	Oral
Subject	KHK2455	Unknown	10 mg	Oral
Subject	KHK2455	Unknown	30 mg	Oral
Subject	KHK2455	Unknown	100 mg	Oral
Subject	Mogamulizumab	Monoclonal antibody	1 mg/kg	Intravenous

KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

Summary

Timeline

Publications

Drugs

Indications