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TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab

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ClinicalTrials.gov Identifier: NCT03856099
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
PharmAbcine

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)		 Adverse Events [ Time Frame: until time of progressive disease or 1 year ]
The frequency and percentage of AEs will be presented by dose goup
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Progression free survival rate at 4 months [ Time Frame: at the end of 4 months ]
    The rate and 2-sided 95% confidence interval of progression free survival at the 4-month
  • Progression free survival rate at 6 months [ Time Frame: at the end of 6 months ]
    The rate and 2-sided 95% confidence interval of progression free survival at the 6-month
  • Progression free survival [ Time Frame: until time of progressive disease or time point of patients' death which come first assessed up to 1 year ]
    Period from the date of the drug administration to the disease progression time point
  • Overall survival [ Time Frame: until time point of patients' death up to 1 year ]
    Period from the date of the drug administration to the time point of patient's death
  • Objective response rate [ Time Frame: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days) ]
    complete response (CR) or partial response (PR) by RANO criteria
  • Disease control rate [ Time Frame: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days) ]
    complete response (CR), partial response (PR) or stable disease (SD) by RANO criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2019)
  • Immunogenicity [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Presence anti-drug antibody (ADA)
  • Pharmacokinetic parameters - Cmax [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Maximum concentration of drug by dose level
  • Pharmacokinetic parameters - Cmin [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Minimum concentration of drug by dose level
  • Pharmacokinetic parameters - AUC0-t [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Area under the curve from baseline to each timepoint by dose level
  • Pharmacokinetic parameters -Tmax [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Time of Cmax by dose level
  • Pharmacokinetic parameters - CL [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Clearance by dose level
  • Pharmacokinetic parameters - Vd [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Volume of distribution by dose level
  • Pharmacokinetic parameters - Ke [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Elimination rate constant by dose level
  • Pharmacokinetic parameters - T½ [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    Half-life by dose level
  • Change in concentration of serum angiogenic factor or receptor [ Time Frame: From screening visit to end of treatment visit (time of progressive disease or 1 year) ]
    VEGF, placental growth factor [PLGF], soluble vascular endothelial growth factor receptor [sVEGFR]-2, sVEGFR-1, etc.
  • DCE-MRI [ Time Frame: Screening visit, on Day8 and Day 15 of cycle 1, Day 28 of every 2nd cycle (1 cycle is 28 days, up to 1 year) ]
    Blood flow parameter - iAUC, K-trans
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
Official Title  ICMJE A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
Brief Summary This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE Drug: TTAC-0001
  • Investigational product (IP): TTAC-0001

  • Treatment groups: 3 dose groups

    • Dose group A : TTAC-0001 16 mg/kg on D1 and D15
    • Dose group B : TTAC-0001 20 mg/kg on D1 and D15
    • Dose group C : TTAC-0001 24 mg/kg on D1 and D15
  • Cycle: 4 weeks (28 days per cycle)
Study Arms  ICMJE Experimental: TTAC-0001
TTAC-0001 with dose assigned to each dose group will be administered
Intervention: Drug: TTAC-0001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)		 36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
  2. Aged at least 18 years old
  3. Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
  4. Patients must have previous treatment including bevacizumab
  5. Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
  6. At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
  7. Patients must undergo IDH1 mutational testing on a tumor specimen before entering the study. Immunohistochemistry (IHC) is sufficient for enrollment, although DNA sequencing may also be performed as per local institutional guidelines. Patients are eligible regardless of their tumor status.
  8. Karnofsky Performance Status (KPS) ≥ 70

  9. A person who satisfies the following criteria in hematologic, renal, and hepatic function tests (1) Hematologic tests - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 75 x 109/L

    - Hemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests

    - Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (ULN)

    - Activated partial thromboplastin Time (aPTT) ≤ 1.5 x ULN (3) Hepatic function tests

    • Total bilirubin ≤ 1.5 x ULN
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (4) Renal function test
    • Creatinine clearance (CrCl) ≥ 30 mL/minute calculated by Cockcroft-Gault formula
  10. Life expectancy of at least 12 weeks
  11. Females of child bearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study.
  12. Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study. Refer to section 10.5.1 Restrictions, permitted methods of contraception and definitions.

Exclusion Criteria:

  1. Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to receiving the first dose of treatment.
  2. The following concomitant diseases:

(1) Uncontrolled hypertension (systolic blood pressure [SBP] > 150 or diastolic blood pressure [DBP] > 90 mmHg) (2) Uncontrolled seizures (3) Class III or IV heart failure according to New York Heart Association (NYHA) classification (4) Oxygen-dependent chronic disease (5) Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.

3) Not recovered from AEs < National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 2 caused by CCRT 4) Treatment with bevacizumab including therapy 2 weeks prior to receiving the first dose of treatment.

5) Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery) 6) Treated with other investigational products within 4 weeks prior to the patient receiving the first dose of treatment.

7) A known history of severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug 8) Unable to participate in the trial according to the investigator's decision. 9) Patient not eligible for sequential MRI evaluations are not eligible for this study 10) Previous therapy with VEGF-targeted agents except bevacizumab. 11) Known active hepatitis B or hepatitis C infection 12) Has received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.

13) Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seonyoung Lee, MPH +8210-4360-2257 sylee@pharmabcine.com
Contact: Jinkyung Kim, BS +827044466393 jinkyung.kim@pharmabcine.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03856099
Other Study ID Numbers  ICMJE PMC_TTAC-0001_03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PharmAbcine
Study Sponsor  ICMJE PharmAbcine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmAbcine
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP