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

Primary Purpose

Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV

Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TBI-1401(HF10)
Gemcitabine
Nab-paclitaxel
TS-1
Sponsored by
Takara Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage III focused on measuring 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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TBI-1401(HF10) + Gem/nab-PTX

TBI-1401(HF10) + TS-1 (primary)

TBI-1401(HF10) + TS-1 (primary and meta)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity (DLT)
Determine the recommended dose of TBI-1401(HF10) in combination with Gemcitabine and Nab-paclitaxel.

Secondary Outcome Measures

Adverse Events (AEs)
Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
Objective response rate (ORR) by RECIST
Overall tumor response evaluated by RECIST version 1.1
Objective response rate (ORR) by irRECIST
Overall tumor response evaluated by irRECIST.
Progression-free survival (PFS) by RECIST
Evaluation the time to progression during and after the treatment.
Progression-free survival (PFS) by irRECIST
Evaluation the time to progression during and after the treatment.

Full Information

First Posted
August 9, 2017
Last Updated
June 15, 2022
Sponsor
Takara Bio Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03252808
Brief Title
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in 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 Patients With Stage III or IV Unresectable Pancreatic Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
March 31, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takara Bio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBI-1401(HF10) + Gem/nab-PTX
Arm Type
Experimental
Arm Description
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.
Arm Title
TBI-1401(HF10) + TS-1 (primary)
Arm Type
Experimental
Arm Description
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.
Arm Title
TBI-1401(HF10) + TS-1 (primary and meta)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
TBI-1401(HF10)
Other Intervention Name(s)
HF10, canerpaturev
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
125 mg/m^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Intervention Type
Drug
Intervention Name(s)
TS-1
Other Intervention Name(s)
Tegafur-gimeracil-oteracil potassium
Intervention Description
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity (DLT)
Description
Determine the recommended dose of TBI-1401(HF10) in combination with Gemcitabine and Nab-paclitaxel.
Time Frame
Through 1st TBI-1401(HF10) injection to before 3rd injection (basically 4 weeks).
Secondary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
Time Frame
Through 1st TBI-1401(HF10) injection to study completion (up to 13 month).
Title
Objective response rate (ORR) by RECIST
Description
Overall tumor response evaluated by RECIST version 1.1
Time Frame
At 16 weeks and through study completion (up to 1 year).
Title
Objective response rate (ORR) by irRECIST
Description
Overall tumor response evaluated by irRECIST.
Time Frame
At 16 weeks and through study completion (up to 1 year).
Title
Progression-free survival (PFS) by RECIST
Description
Evaluation the time to progression during and after the treatment.
Time Frame
Through disease progression (up to 1 year).
Title
Progression-free survival (PFS) by irRECIST
Description
Evaluation the time to progression during and after the treatment.
Time Frame
Through disease progression (up to 1 year).
Other Pre-specified Outcome Measures:
Title
Overall survival (OS)
Description
Evaluation the overall survival.
Time Frame
From 1st treatment to death (up to 2 years).
Title
1 year survival rate
Description
Determine the 1 year survival rate of patient who received treatment.
Time Frame
for 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takara Bio Inc.
Organizational Affiliation
Clinical Development & Strategy Division 2
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Clinical Site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Clinical Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Clinical Site
City
Chūōku
State/Province
Tokyo
Country
Japan
Facility Name
Clinical Site
City
Koto-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Clinical Site
City
Chiba
Country
Japan
Facility Name
Clinical Site
City
Nagoya
Country
Japan
Facility Name
Clinical Site
City
Osaka
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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