Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma

Summary

Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial Study objective: 1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma. 2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma. 3. Exploratory * To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma * To evaluate pharmacodynamic (PD) parameters by clinical biomarker test Study Methodology Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case. A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.

Timeline

Start

2016-02-04

Primary completion

2017-06-02

Completion

2017-06-02

Drugs

Indications