NCT02442414

A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Detailed description

This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KBP-5209	Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.

Timeline

• Start date: 2015-04-07
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2015-05-13
• Last updated: 2022-03-04

Locations

3 sites across 1 country: United States