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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI-1401(HF10) + Gem/nab-PTX | Experimental | 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) + TS-1 (primary) | Experimental | 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) + TS-1 (primary and meta) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Evaluation the overall survival. | From 1st treatment to death (up to 2 years). |
| 1 year survival rate | Determine the 1 year survival rate of patient who received treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takara Bio Inc. | Clinical Development & Strategy Division 2 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Nagoya | Aichi-ken | Japan | |||
| Clinical Site |
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| Gemcitabine | Drug | 1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest. |
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| Nab-paclitaxel | Drug | 125 mg/m^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest. |
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| TS-1 | Drug | TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest. |
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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 | Overall tumor response evaluated by irRECIST. | 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. | Through disease progression (up to 1 year). |
| Progression-free survival (PFS) by irRECIST | Evaluation the time to progression during and after the treatment. | Through disease progression (up to 1 year). |
| for 1 year. |
| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| C103828 | titanium silicide |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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