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 A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Adverse events
Time frame: up to 1 year
PFS at 6-month time point
Time frame: 6 months
Objective response rate (ORR)
The rate of complete response and partial response assessed according to RANO criteria.
Time frame: up to 1 year
Disease control rate(DCR)
The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.