Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

NCT02004717 ↗

Phase 1 Completed 37 enrolled Daiichi Sankyo

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.

Timeline

Start: 2013-10
Primary completion: 2017-02
Completion: 2017-02

Publications

Shitara K, Satoh T, Iwasa S, Yamaguchi K, Muro K, Komatsu Y, Nishina T, Esaki T, Hasegawa J, Kakurai Y, Kamiyama E, Nakata T, Nakamura K, Sakaki H, Hyodo I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors. J Immunother Cancer. 2019 Aug 14;7(1):219. doi: 10.1186/s40425-019-0679-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DS-8895a	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	DS-8895a	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	DS-8895a	Monoclonal antibody	1 mg/kg	Intravenous
Subject	DS-8895a	Monoclonal antibody	3 mg/kg	Intravenous
Subject	DS-8895a	Monoclonal antibody	10 mg/kg	Intravenous
Subject	DS-8895a	Monoclonal antibody	20 mg/kg	Intravenous

Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications