Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors

Phase 1 Completed 46 enrolled Niiki Pharma Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339, a ruthenium containing compound administered intravenously on a weekly schedule, in patients with advanced solid tumors. The responses to treatment in this population will be evaluated. In addition, the PD and PK properties of the compound will be explored.

Timeline

Start: 2009-10
Primary completion: 2012-05
Completion: 2016-01

Publications

Burris HA, Bakewell S, Bendell JC, Infante J, Jones SF, Spigel DR, Weiss GJ, Ramanathan RK, Ogden A, Von Hoff D. Safety and activity of IT-139, a ruthenium-based compound, in patients with advanced solid tumours: a first-in-human, open-label, dose-escalation phase I study with expansion cohort. ESMO Open. 2017 Feb 23;1(6):e000154. doi: 10.1136/esmoopen-2016-000154. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IT-139	Small molecule	20 mg/m2	Intravenous
Subject	IT-139	Small molecule	40 mg/m2	Intravenous
Subject	IT-139	Small molecule	80 mg/m2	Intravenous
Subject	IT-139	Small molecule	160 mg/m2	Intravenous
Subject	IT-139	Small molecule	320 mg/m2	Intravenous
Subject	IT-139	Small molecule	420 mg/m2	Intravenous
Subject	IT-139	Small molecule	500 mg/m2	Intravenous
Subject	IT-139	Small molecule	625 mg/m2	Intravenous
Subject	IT-139	Small molecule	780 mg/m2	Intravenous

Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications