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

Overview

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 A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2, 2017

Interventions

  • Drug: TTAC-0001
    • Calculated amount of drug will be diluted with normal saline and administered intravenously.

Arms, Groups and Cohorts

  • Experimental: Cohort 1
    • Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
  • Experimental: Cohort 2
    • Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
  • Experimental: Cohort 3
    • Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events
    • Time Frame: up to 1 year

Secondary Measures

  • PFS at 6-month time point
    • Time Frame: 6 months
  • Objective response rate (ORR)
    • Time Frame: up to 1 year
    • The rate of complete response and partial response assessed according to RANO criteria.
  • Disease control rate(DCR)
    • Time Frame: up to 1 year
    • The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.
  • Overall survival(OS)
    • Time Frame: up to 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Both male and female patients ≥19 years old – Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable. – At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria – Karnofsky Performance Status (KPS) ≥ 80 – A person who satisfies the following criteria in hematologic, renal, and hepatic function tests – At least 12 weeks of expected survival time – Signed informed consent Exclusion Criteria:

  • Diagnosed with other malignant tumor within 2years – Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder – Not recovered grade 2 AE due to previous CCRT – Major surgery or other investigational drug treatment within 4 weeks – Pregnant/lactating female and female/male potential childbearing without contraception – Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug – Expectation of poor compliance – Previous therapy with VEGF targeted agent

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PharmAbcine
  • Provider of Information About this Clinical Study
    • Sponsor

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