NCT01159522

A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

A Phase 1 Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: SynCore Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study with SCB01A is to determine the Maximum Tolerated Dose of SCB01A in patients with advanced solid tumors that have failed previous therapy.

Detailed description

This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	SCB01A	This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

Timeline

• Start date: 2011-04-01
• Primary completion: 2017-07-01
• Completion: 2017-07-11
• First posted: 2010-07-09
• Last updated: 2017-10-19

Locations

3 sites across 1 country: Taiwan