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

Recurrent Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033524
• Other study ID #: PMC_TTAC-0001_02
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: January 2021
• Source: PharmAbcine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Drug:
• TTAC-0001
Calculated amount of drug will be diluted with normal saline and administered intravenously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PharmAbcine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area under the concentration-time curve (AUC)	Pharmacokinetics profile	up to 1 year
Other	Maximum plasma concentration (Cmax)	Pharmacokinetics profile	up to 1 year
Other	Minimum plasma concentration (Cmin)	Pharmacokinetics profile	up to 1 year
Other	Clearance (CL)	Pharmacokinetics profile	up to 1 year
Other	Volume of distribution (Vd)	Pharmacokinetics profile	up to 1 year
Other	Half-life (t1/2)	Pharmacokinetics profile	up to 1 year
Other	Angiogenic factors in serum or changes in concentration	Pharmacodynamics profile	up to 1 year
Other	Perfusion parameter assessed by DCE-MRI	Pharmacodynamics profile	every 2 cycles(each cycle is 4 weeks), up to 1year
Other	Expression of angiogenic factors in endothelial cells	Analyzed by IHC of tumor tissue	At screening
Other	Immunogenicity	Anti-drug (TTAC-0001) antibody (ADA) test for evaluation of immunogenicity	Day 1 of every cycle(each cycle is 4 weeks), up to 1 year
Primary	Adverse events		up to 1 year
Secondary	PFS at 6-month time point		6 months
Secondary	Objective response rate (ORR)	The rate of complete response and partial response assessed according to RANO criteria.	up to 1 year
Secondary	Disease control rate(DCR)	The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.	up to 1 year
Secondary	Overall survival(OS)		up to 1 year