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

Phase 1Active Not RecruitingNCT03252808

Takara Bio Inc.36 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Stage III Pancreatic Cancer Stage IV

Interventions

TBI-1401(HF10)BIOLOGICAL

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.

GemcitabineDRUG

1000 mg/m\^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.

Nab-paclitaxelDRUG

125 mg/m\^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (8)

Clinical Site

Nagoya, Aichi-ken, Japan

Clinical Site

Chiba, Chiba, Japan

Clinical Site

Kashiwa, Chiba, Japan

Clinical Site

Yokohama, Kanagawa, Japan

Outcomes

Primary Outcomes

Dose Limiting Toxicity (DLT)

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 Outcomes

Adverse Events (AEs)

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).

Objective response rate (ORR) by RECIST

Overall tumor response evaluated by RECIST version 1.1

Time frame: At 16 weeks and through study completion (up to 1 year).

Objective response rate (ORR) by irRECIST

Overall tumor response evaluated by irRECIST.

Time frame: At 16 weeks and through study completion (up to 1 year).

Progression-free survival (PFS) by RECIST

Evaluation the time to progression during and after the treatment.

Time frame: Through disease progression (up to 1 year).

Progression-free survival (PFS) by irRECIST

Evaluation the time to progression during and after the treatment.

Time frame: Through disease progression (up to 1 year).

Data from ClinicalTrials.gov

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