Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer

Phase 1 Terminated 22 enrolled Kyowa Kirin, Inc. Kyowa Hakko Kirin Pharma, Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in subjects platinum-sensitive and platinum-resistant ovarian cancer.

Timeline

Start: 2011-01
Primary completion: 2012-11
Completion: 2012-11

Outcome

Outcome not reported

Stopped: “The study was stopped due to the inability to determine an acceptable dose with the potential for further study”

Publications

Sarantopoulos J, Mita MM, Birrer MJ, Cranmer LD, Campos LT, Zhang X, Bristow P, Kaito H, Strout V, Camacho LH. Phase 1 Study of Monotherapy with KHK2866, an Anti-Heparin-Binding Epidermal Growth Factor-Like Growth Factor Monoclonal Antibody, in Patients with Advanced Cancer. Target Oncol. 2016 Jun;11(3):317-27. doi: 10.1007/s11523-015-0394-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KHK2866	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	KHK2866	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	KHK2866	Monoclonal antibody	1 mg/kg	Intravenous
Subject	KHK2866	Monoclonal antibody	3 mg/kg	Intravenous
Background	Carboplatin	Small molecule	4 unknown	—
Background	Gemcitabine	Small molecule	1000 mg/m2	—
Background	Paclitaxel	Small molecule	80 mg/m2	—
Background	Pegylated liposomal doxorubicin	Unknown	40 mg/m2	—