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A Study of TBI-1401(HF10) in Patients With Solid Tumors With Superficial Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takara Bio Inc.
ClinicalTrials.gov Identifier:
NCT02428036
First received: April 16, 2015
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of solid tumors with superficial lesions.

Condition Intervention Phase
Solid Tumor Biological: TBI-1401(HF10) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Repeated Intratumoral Administration of TBI-1401(HF10), a Replication Competent HSV-1 Oncolytic Virus, in Patients With Solid Tumors With Superficial Lesions

Further study details as provided by Takara Bio Inc.:

Primary Outcome Measures:
  • Safety and tolerability (CTCAE version 4.0). [ Time Frame: up to Week 16 ]
    Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).


Secondary Outcome Measures:
  • Overall tumor response (modified World Health Organization response criteria) [ Time Frame: at Week 12 ]
    Overall tumor response will be evaluated by modified World Health Organization (mWHO) response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

  • Levels of antibody to HSV-1 [ Time Frame: up to Week 12 ]
    Anti-HSV-1 antibodies will be assessed in serum.


Other Outcome Measures:
  • Change in cytokine profiles in serum [ Time Frame: up to Week 12 ]
    Evaluation of cytokine profiles in serum by immunoassay.

  • Change in antitumor T-cell reactivity in serum [ Time Frame: up to Week 12 ]
    Antitumor T-cell reactivity in serum will be evaluated by flow cytometry.

  • Change in regulatory T-cell (Treg) population in serum [ Time Frame: up to Week 12 ]
    Treg population in serum will be evaluated by flow cytometry.

  • Histopathological response with TBI-1401(HF10) administrated tumor [ Time Frame: at Week 12 ]
    Core biopsies will be performed to evaluate the histopathological response with TBI-1401(HF10) administrated tumor.


Enrollment: 6
Study Start Date: June 2015
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TBI-1401(HF10) - Cohort 1
Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)
Biological: TBI-1401(HF10)
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^6 TCID50/mL.
Experimental: TBI-1401(HF10) - Cohort 2
Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)
Biological: TBI-1401(HF10)
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^7 TCID50/mL.

Detailed Description:

This is an open label, non-randomized, dose escalation Phase I study evaluating the repeated intratumoral administrations of the TBI-1401(HF10), a spontaneously attenuated mutant of HSV-1, in patients with solid tumors with superficial lesions (e.g., malignant melanoma and squamous cell carcinoma of the skin).

The study will evaluate the safety and tolerability of repeated intratumoral administrations of TBI-1401(HF10) at dose levels of 1 x 10^6 TCID50/dose (cohort 1) and 1 x 10^7 TCID50/dose (cohort 2) in Japanese patients. Three patients will be enrolled in each cohort. Patients in the each cohort will receive a total of four intratumoral administrations in the same lesion.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed solid tumors with superficial lesions.
  • Patients must have unresectable and standard therapies-resistant solid tumors.
  • Patients must be ≥ 20 years of age.
  • Patients must have a life expectancy ≥ 12 weeks.
  • Patients must have measurable non-visceral lesion(s) that are evaluable by the mWHO response criteria.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined as

    • Absolute neutrophil count ≥ 1,500/μL.
    • Platelet count ≥ 100,000/μL.
    • Total bilirubin levels ≤ 1.5 x upper limit of normal (ULN).
    • AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present.
    • creatinine ≤ 1.5 x ULN.
    • creatinine clearance (calculated) ≥ 60 mL/min/1.73 m^2 for patients with creatinine > 1.5 x ULN.
  • Patients must have passed 4 weeks after the completion of prior therapy [except bone metastasis therapy], or passed 8 weeks if immuno checkpoint inhibitor was treated.
  • Patients must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
  • Patients with Grade 2 adverse events Grade 2 or greater, except alopecia, resulting from anticancer agents administered more than 4 weeks prior to TBI-1401(HF10) administration.
  • Patients receiving anti-herpes medication [except local treatment such as ointment].
  • Patients receiving steroids or immunosuppressive agents [except inhaled steroid].
  • Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection.
  • Patients receiving anti-platelet medication.
  • Patients receiving anti-coagulation medication.
  • Patients with presence or medical history of central nervous system metastasis.
  • Patients with Grade ≥ 2 pre-existing neurologic abnormalities (CTCAE version 4.0).
  • Patients with severe cardiac disorder or abnormal cardiac rhythm.
  • Patients with psychiatric disorder or drug dependency which affects informed consent.
  • Pregnant or breastfeeding women; women or men, having normal reproductive potential, who disagree with the protection of pregnancy within the timeframe of the study.
  • Patients received any other investigational products within 4 weeks, or within 8 weeks if immuno checkpoint inhibitor was treated.
  • Patients would limit compliance with study requirements, as determined by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02428036

Locations
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Takara Bio Inc.
Investigators
Principal Investigator: Naoya Yamazaki National Cancer Center Hospital
  More Information

Responsible Party: Takara Bio Inc.
ClinicalTrials.gov Identifier: NCT02428036     History of Changes
Other Study ID Numbers: TBI1401-01
Study First Received: April 16, 2015
Last Updated: October 27, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Takara Bio Inc.:
TBI-1401(HF10)
HF10
HSV-1
Oncolytic virus
Oncolytic virotherapy
Phase I
Melanoma
Intratumoral administration

ClinicalTrials.gov processed this record on June 23, 2017