Clinical Trials /

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

NCT03856099

Description:

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.

Related Conditions:
  • Glioblastoma
  • Gliosarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: PMC_TTAC-0001_03
  • NCT ID: NCT03856099

Conditions

  • Recurrent Glioblastoma

Interventions

DrugSynonymsArms
TTAC-0001TTAC-0001

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TTAC-0001ExperimentalTTAC-0001 with dose assigned to each dose group will be administered
  • TTAC-0001

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events
Time Frame:until time of progressive disease or 1 year
Safety Issue:
Description:The frequency and percentage of AEs will be presented by dose goup

Secondary Outcome Measures

Measure:Progression free survival rate at 4 months
Time Frame:at the end of 4 months
Safety Issue:
Description:The rate and 2-sided 95% confidence interval of progression free survival at the 4-month
Measure:Progression free survival rate at 6 months
Time Frame:at the end of 6 months
Safety Issue:
Description:The rate and 2-sided 95% confidence interval of progression free survival at the 6-month
Measure:Progression free survival
Time Frame:until time of progressive disease or time point of patients' death which come first assessed up to 1 year
Safety Issue:
Description:Period from the date of the drug administration to the disease progression time point
Measure:Overall survival
Time Frame:until time point of patients' death up to 1 year
Safety Issue:
Description:Period from the date of the drug administration to the time point of patient's death
Measure: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)
Safety Issue:
Description:complete response (CR) or partial response (PR) by RANO criteria
Measure: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)
Safety Issue:
Description:complete response (CR), partial response (PR) or stable disease (SD) by RANO criteria

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:PharmAbcine

Last Updated