Back to resultsTrial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
Primary Purpose
Recurrent Glioblastoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TTAC-0001
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
PFS at 6-month time point
Objective response rate (ORR)
The rate of complete response and partial response assessed according to RANO criteria.
Disease control rate(DCR)
The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.
Overall survival(OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03033524
Brief Title
Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmAbcine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
Intervention Type
Drug
Intervention Name(s)
TTAC-0001
Other Intervention Name(s)
Tanibirumab
Intervention Description
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
PFS at 6-month time point
Time Frame
6 months
Title
Objective response rate (ORR)
Description
The rate of complete response and partial response assessed according to RANO criteria.
Time Frame
up to 1 year
Title
Disease control rate(DCR)
Description
The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.
Time Frame
up to 1 year
Title
Overall survival(OS)
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
Area under the concentration-time curve (AUC)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Maximum plasma concentration (Cmax)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Minimum plasma concentration (Cmin)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Clearance (CL)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Volume of distribution (Vd)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Half-life (t1/2)
Description
Pharmacokinetics profile
Time Frame
up to 1 year
Title
Angiogenic factors in serum or changes in concentration
Description
Pharmacodynamics profile
Time Frame
up to 1 year
Title
Perfusion parameter assessed by DCE-MRI
Description
Pharmacodynamics profile
Time Frame
every 2 cycles(each cycle is 4 weeks), up to 1year
Title
Expression of angiogenic factors in endothelial cells
Description
Analyzed by IHC of tumor tissue
Time Frame
At screening
Title
Immunogenicity
Description
Anti-drug (TTAC-0001) antibody (ADA) test for evaluation of immunogenicity
Time Frame
Day 1 of every cycle(each cycle is 4 weeks), up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
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