A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy
NCT01159522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2017-10-19
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
SynCore Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Muh-Hwan Su, Ph.D. · SynCore Biotechnology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2017-07-31
- Completion
- 2017-07-11
Countries
- Taiwan
Study Locations
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