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

PharmAbcine

Status and phase: Completed; Phase 2

Conditions: Recurrent Glioblastoma

Treatments: Drug: TTAC-0001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03033524

PMC_TTAC-0001_02

Details and patient eligibility

About

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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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

Enrollment: 12 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Cohort 1

Experimental group

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.

Treatment:

Drug: TTAC-0001

Cohort 2

Experimental group

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.

Treatment:

Drug: TTAC-0001

Cohort 3

Experimental group

Description:

Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.

Treatment:

Drug: TTAC-0001