Clinical Trials /

Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Japanese Patients With Unresectable Pancreatic Cancer.

NCT03252808

Description:

The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese patients with stage III or IV unresectable pancreatic cancer.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Japanese Patients With Unresectable Pancreatic Cancer.
  • Official Title: Phase I Study of Combination With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Japanese Patients With Stage III or IV Unresectable Pancreatic Cancer.

Clinical Trial IDs

  • ORG STUDY ID: TBI1401-03
  • NCT ID: NCT03252808

Conditions

  • Pancreatic Cancer Stage III
  • Pancreatic Cancer Stage IV

Interventions

DrugSynonymsArms
TBI-1401(HF10)HF10, canerpaturevTBI-1401(HF10) + Gem/nab-PTX
GemcitabineGemzarTBI-1401(HF10) + Gem/nab-PTX
Nab-paclitaxelAbraxaneTBI-1401(HF10) + Gem/nab-PTX
TS-1Tegafur-gimeracil-oteracil potassiumTBI-1401(HF10) + TS-1 (primary)

Purpose

The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese patients with stage III or IV unresectable pancreatic cancer.

Detailed Description

      A Phase I, open-label, multi-center study to determine the recommended dose of TBI-1401(HF10)
      treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese
      patients with stage III or IV unresectable pancreatic cancer. Patients with stage IV must
      failed a gemcitabine based first-line chemotherapy.

      Patients with stage III will receive the repeated intratumoral injection of TBI-1401(HF10) at
      recommended dose at 2-week intervals in combination with intravenous infusion of 1000 mg/m^2
      Gemcitabine and 125 mg/m^2 Nab-paclitaxel at weekly for 3 weeks followed by 1 week rest.

      Patients with stage IV will receive the repeated intratumoral injection of TBI-1401(HF10) at
      recommended dose at 2-week intervals in combination with oral of 40 - 60 mg TS-1 at twice
      daily for 4 weeks followed by 2 weeks rest.

      Patients will receive the combination therapy of TBI-1401(HF10) + chemo for up to 1 year if
      eligible for treatment.
    

Trial Arms

NameTypeDescriptionInterventions
TBI-1401(HF10) + Gem/nab-PTXExperimental1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and 1000 mg/m^2 Gemcitabine and 125 mg/m^2 Nab-paclitaxel injected by intravenous infusions.
  • Gemcitabine
  • Nab-paclitaxel
TBI-1401(HF10) + TS-1 (primary)Experimental1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the primary tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and TS-1 administered by oral.
  • TS-1
TBI-1401(HF10) + TS-1 (primary and meta)Experimental1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered to the primary tumor in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection and hepatic metastasis in a total volume up to 2.0 mL (injection volume will be adjusted based on the tumor size) by EUS-guided intratumoral injection or percutaneous injection and TS-1 administered by oral.
  • TS-1

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed unresectable pancreatic cancer
             (stage III or IV) based on the General Rules for the Study of Pancreatic Cancer (The
             7th edition), and never received anti-cancer therapy (radiation therapy, chemotherapy,
             immunotherapy, surgery, clinical trials).

          -  Patients with primary lesion will be intratumorally injectable for TBI-1401(HF10) by
             EUS (endoscopic ultrasound).

          -  Patients must be ≧20 years of age.

          -  Patients must have at least one measurable lesion evaluated by Computed Tomography
             (CT) scan on RECIST ver.1.1 at pre-treatment.

          -  Patients must have a life expectancy ≧12 weeks.

          -  Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status)
             of 0-1.

          -  Patients demonstrated adequate organ function (≦7 days prior to treatment).

          -  Females of childbearing potential must have a negative urine or serum pregnancy test
             within 1 week prior to start of treatment.

          -  Patients must be able to understand the study and willing to sign a written informed
             consent document.

        Exclusion Criteria:

          -  Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10)
             treatment (except local treatment such as ointment).

          -  Patients with a significant tumor bleeding or coagulation abnormality that could not
             treat intratumoral injection or biopsy in safe.

          -  Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis
             C virus (HCV) antibody positive and HSV-RNA positive, Human Immunodeficiency Virus
             (HIV) antibody positive.

          -  Patients with the active symptom of Epstein-Barr virus (EBV) infection.

          -  Patients with active CNS metastases.

          -  Patients with ascites, except acceptable mild ascites.

          -  Patients with multiple cancer.

          -  Patients need to treat anticoagulant or antiplatelet agent.

          -  Patients has a history of allergy for CT contrast agent, live vaccine, any drug
             excipients, Nab-paclitaxel, Gemcitabine, or any study drugs.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity (DLT)
Time Frame:Through 1st TBI-1401(HF10) injection to before 3rd injection (basically 4 weeks).
Safety Issue:
Description:Determine the recommended dose of TBI-1401(HF10) in combination with Gemcitabine and Nab-paclitaxel.

Secondary Outcome Measures

Measure:Adverse Events (AEs)
Time Frame:Through 1st TBI-1401(HF10) injection to study completion (up to 13 month).
Safety Issue:
Description:Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
Measure:Objective response rate (ORR) by RECIST
Time Frame:At 16 weeks and through study completion (up to 1 year).
Safety Issue:
Description:Overall tumor response evaluated by RECIST version 1.1
Measure:Objective response rate (ORR) by irRECIST
Time Frame:At 16 weeks and through study completion (up to 1 year).
Safety Issue:
Description:Overall tumor response evaluated by irRECIST.
Measure:Progression-free survival (PFS) by RECIST
Time Frame:Through disease progression (up to 1 year).
Safety Issue:
Description:Evaluation the time to progression during and after the treatment.
Measure:Progression-free survival (PFS) by irRECIST
Time Frame:Through disease progression (up to 1 year).
Safety Issue:
Description:Evaluation the time to progression during and after the treatment.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Takara Bio Inc.

Trial Keywords

  • Unresectable pancreatic cancer
  • Metastatic pancreatic cancer
  • Pancreatic adenocarcinoma
  • TBI-1401(HF10)
  • HF10
  • Oncolytic virus
  • Oncolytic viral immunotherapy
  • Gemcitabine
  • Nab-paclitaxel
  • Albumin-bound paclitaxel
  • Abraxane
  • Tegafur-gimeracil-oteracil potassium
  • TS-1
  • canerpaturev

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