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Completed

NCT Number: NCT03033524

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

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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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

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Key information

Conditions

Recurrent Glioblastoma Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTAC-0001

Drug

Calculated amount of drug will be diluted with normal saline and administered intravenously.

Other names: Tanibirumab

Primary outcomes

  1. Adverse events

    Time frame: up to 1 year

Secondary outcomes

  1. PFS at 6-month time point

    Time frame: 6 months

  2. Objective response rate (ORR)

    Time frame: up to 1 year

    The rate of complete response and partial response assessed according to RANO criteria.

  3. 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.

  4. Overall survival(OS)

    Time frame: up to 1 year

Other outcomes

  1. Area under the concentration-time curve (AUC)

    Time frame: up to 1 year

    Pharmacokinetics profile

  2. Maximum plasma concentration (Cmax)

    Time frame: up to 1 year

    Pharmacokinetics profile

  3. Minimum plasma concentration (Cmin)

    Time frame: up to 1 year

    Pharmacokinetics profile

  4. Clearance (CL)

    Time frame: up to 1 year

    Pharmacokinetics profile

  5. Volume of distribution (Vd)

    Time frame: up to 1 year

    Pharmacokinetics profile

  6. Half-life (t1/2)

    Time frame: up to 1 year

    Pharmacokinetics profile

  7. Angiogenic factors in serum or changes in concentration

    Time frame: up to 1 year

    Pharmacodynamics profile

  8. Perfusion parameter assessed by DCE-MRI

    Time frame: every 2 cycles(each cycle is 4 weeks), up to 1year

    Pharmacodynamics profile

  9. Expression of angiogenic factors in endothelial cells

    Time frame: At screening

    Analyzed by IHC of tumor tissue

  10. Immunogenicity

    Time frame: Day 1 of every cycle(each cycle is 4 weeks), up to 1 year

    Anti-drug (TTAC-0001) antibody (ADA) test for evaluation of immunogenicity

Sponsors and collaborators

Lead sponsor

PharmAbcine

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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