Clinical trial NCT03033524: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Glioblastoma
Lead sponsor: PharmAbcine
Sponsor class: INDUSTRY
First posted: 2017-01-26
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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


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

Primary outcomes:
measure: Adverse events
timeFrame: up to 1 year
Secondary outcomes:
measure: PFS at 6-month time point
timeFrame: 6 months
measure: Objective response rate (ORR)
timeFrame: up to 1 year
measure: Disease control rate(DCR)
timeFrame: up to 1 year
measure: Overall survival(OS)
timeFrame: up to 1 year
Other outcomes:
measure: Area under the concentration-time curve (AUC)
timeFrame: up to 1 year
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 1 year
measure: Minimum plasma concentration (Cmin)
timeFrame: up to 1 year
measure: Clearance (CL)
timeFrame: up to 1 year
measure: Volume of distribution (Vd)
timeFrame: up to 1 year
measure: Half-life (t1/2)
timeFrame: up to 1 year
measure: Angiogenic factors in serum or changes in concentration
timeFrame: up to 1 year
measure: Perfusion parameter assessed by DCE-MRI
timeFrame: every 2 cycles(each cycle is 4 weeks), up to 1year
measure: Expression of angiogenic factors in endothelial cells
timeFrame: At screening
measure: Immunogenicity
timeFrame: Day 1 of every cycle(each cycle is 4 weeks), up to 1 year
Locations:
Study officials:
References: