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

December 5, 2023 updated by: Takara Bio Inc.

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

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 patients with stage III or IV unresectable pancreatic cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Clinical Site
      • Nagoya, Japan
        • Clinical Site
      • Osaka, Japan
        • Clinical Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Clinical Site
    • Chiba
      • Kashiwa, Chiba, Japan
        • Clinical Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Clinical Site
    • Tokyo
      • Chūōku, Tokyo, Japan
        • Clinical Site
      • Koto-Ku, Tokyo, Japan
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TBI-1401(HF10) + Gem/nab-PTX
1x10^6 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.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev
Drug: Gemcitabine
1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Other Names:
  • Gemzar
Drug: Nab-paclitaxel
125 mg/m^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Other Names:
  • Abraxane
Experimental: TBI-1401(HF10) + TS-1 (primary)
1x10^6 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.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev
Drug: TS-1
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Other Names:
  • Tegafur-gimeracil-oteracil potassium
Experimental: TBI-1401(HF10) + TS-1 (primary and meta)
1x10^6 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.
Biological: TBI-1401(HF10)
1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Other Names:
  • HF10
  • canerpaturev
Drug: TS-1
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Other Names:
  • Tegafur-gimeracil-oteracil potassium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From 1st treatment to death (up to 2 years).
Evaluation the overall survival.
From 1st treatment to death (up to 2 years).
1 year survival rate
Time Frame: for 1 year.
Determine the 1 year survival rate of patient who received treatment.
for 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takara Bio Inc.

Investigators

  • Study Director: Takara Bio Inc., Clinical Development & Strategy Division 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

February 19, 2020

Study Completion (Estimated)

March 31, 2035

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBI1401-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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