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

Recurrent Glioblastoma Clinical Trial

Official title: A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma

Status Completed

Clinical Trial 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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

• NCT number: NCT03033524
• Study type: Interventional
• Source: PharmAbcine
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2016
• Completion date: June 2, 2017