cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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 A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03033524
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 PharmAbcine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Arms & Interventions

Arms

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.

Interventions

Drug: - TTAC-0001

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Powered By