A Phase 2 interventional study of TTAC-0001 in Recurrent Glioblastoma, sponsored by PharmAbcine. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by PharmAbcine · Phase 2, Interventional, and Treatment
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
Exploratory
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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →PharmAbcine is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Drug: TTAC-0001
Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
Drug: TTAC-0001
Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
Drug: TTAC-0001
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Also known as: Tanibirumab
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
Area under the concentration-time curve (AUC)
Pharmacokinetics profile
Time frame: up to 1 year
Maximum plasma concentration (Cmax)
Pharmacokinetics profile
Time frame: up to 1 year
Minimum plasma concentration (Cmin)
Pharmacokinetics profile
Time frame: up to 1 year
Clearance (CL)
Pharmacokinetics profile
Time frame: up to 1 year
Volume of distribution (Vd)
Pharmacokinetics profile
Time frame: up to 1 year
Half-life (t1/2)
Pharmacokinetics profile
Time frame: up to 1 year
Angiogenic factors in serum or changes in concentration
Pharmacodynamics profile
Time frame: up to 1 year
Perfusion parameter assessed by DCE-MRI
Pharmacodynamics profile
Time frame: every 2 cycles(each cycle is 4 weeks), up to 1year
Expression of angiogenic factors in endothelial cells
Analyzed by IHC of tumor tissue
Time frame: At screening
Immunogenicity
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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PharmAbcine