Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients With Unresectable Pancreatic Cancer.
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ClinicalTrials.gov Identifier: NCT03252808 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : June 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Cancer Stage III Pancreatic Cancer Stage IV | Biological: TBI-1401(HF10) Drug: Gemcitabine Drug: Nab-paclitaxel Drug: TS-1 | Phase 1 |
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 (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | September 25, 2017 |
Actual Primary Completion Date : | February 19, 2020 |
Estimated Study Completion Date : | March 31, 2035 |

Arm | Intervention/treatment |
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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.
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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:
Drug: Gemcitabine 1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Other Name: 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 Name: 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:
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 Name: 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:
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 Name: Tegafur-gimeracil-oteracil potassium |
- 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.
- 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).
- 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
- 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.
- 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.
- 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.
- Overall survival (OS) [ Time Frame: From 1st treatment to death (up to 2 years). ]Evaluation the overall survival.
- 1 year survival rate [ Time Frame: for 1 year. ]Determine the 1 year survival rate of patient who received treatment.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252808
Japan | |
Clinical Site | |
Nagoya, Aichi, Japan | |
Clinical Site | |
Kashiwa, Chiba, Japan | |
Clinical Site | |
Yokohama, Kanagawa, Japan | |
Clinical Site | |
Chūōku, Tokyo, Japan | |
Clinical Site | |
Koto-Ku, Tokyo, Japan | |
Clinical Site | |
Chiba, Japan | |
Clinical Site | |
Nagoya, Japan | |
Clinical Site | |
Osaka, Japan |
Study Director: | Takara Bio Inc. | Clinical Development & Strategy Division 2 |
Responsible Party: | Takara Bio Inc. |
ClinicalTrials.gov Identifier: | NCT03252808 |
Other Study ID Numbers: |
TBI1401-03 |
First Posted: | August 17, 2017 Key Record Dates |
Last Update Posted: | June 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Paclitaxel Tegafur Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |