Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.
NCT ID: NCT03252808
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2017-09-25
2035-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Gemcitabine
1000 mg/m\^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Nab-paclitaxel
125 mg/m\^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Gemcitabine
1000 mg/m\^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Nab-paclitaxel
125 mg/m\^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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Takara Bio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Takara Bio Inc.
Role: STUDY_DIRECTOR
Clinical Development & Strategy Division 2
Locations
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Clinical Site
Nagoya, Aichi-ken, Japan
Clinical Site
Chiba, Chiba, Japan
Clinical Site
Kashiwa, Chiba, Japan
Clinical Site
Yokohama, Kanagawa, Japan
Clinical Site
Osaka, Osaka, Japan
Clinical Site
Chūōku, Tokyo, Japan
Clinical Site
Koto-Ku, Tokyo, Japan
Clinical Site
Nagoya, , Japan
Countries
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Other Identifiers
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TBI1401-03
Identifier Type: -
Identifier Source: org_study_id