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All Drugs and Chemicals

Antineoplastic Agents

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Ipilimumab

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Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

1x10\^7 TCID50/mL TBI-1401(HF10) administered to a single or multiple eligible tumors in a total volume up to 5.0 mL (injection volume will be adjusted based on the size of tumor mass) by intratumoral injection and 3 mg/kg ipilimumab administered by intravenous infusions.

1x10\^7 TCID50/mL TBI-1401(HF10) (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals).

Following combination therapy, patients may continue to receive the 1x10\^7 TCID50/mL TBI-1401(HF10) alone for up to an additional 13 injections (total of 19 injections = 1 year) if eligible for administration.

TBI-1401(HF10)

3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Naoya Yamazaki

The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.

The study is designed to assess efficacy and safety with repeated administration of intratumoral injections of TBI-1401(HF10) at 1x10\^7 TCID50/mL in combination with intravenous infusions of 3mg/kg ipilimumab in Japanese patients.

This is a single arm, open label Phase II study, to evaluate the efficacy and safety of TBI-1401(HF10) treatment in combination with the immunologic checkpoint inhibitor, ipilimumab (anti-CTLA-4 monoclonal antibody). The study population will include patients with Stage IIIB, IIIC or IV unresectable or metastatic malignant melanoma who are ipilimumab-eligible.

Patients will receive the dose of 1x10\^7 TCID50/mL TBI-1401(HF10) (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) + ipilimumab at 3 mg/kg (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Following combination therapy, patients may continue to receive the 1x10\^7 TCID50/mL TBI-1401(HF10) alone for up to an additional 13 injections (total of 19 injections = 1 year) if they have tolerated the study treatment, are responding, have stable disease, or have progressive disease that is not clinically significant in the judgment of the Investigator.

A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma

A Phase II Study of Combination Treatment With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Japanese Patients With Stage IIIB, IIIC, or IV Unresectable or Metastatic Malignant Melanoma

Evaluate the change of anti-HSV-1 antibody levels.

Analysis the change of cytokine profiles, antitumor T-cell reactivity and regulatory T-cell (Treg) population by immunoassay and flow cytometry.

Biopsies will be performed to evaluate the histopathological response with TBI-1401(HF10) administrated tumor.

Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by irRC (immuno-related response criteria)

Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by modified WHO (mWHO) response criteria

Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by RECIST version 1.1

Overall tumor response evaluated by irRC in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

Overall tumor response evaluated by mWHO response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

Overall tumor response evaluated by RECIST version 1.1 in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

Evaluation the time to progression during and after the treatment.

Evaluation the length of time after a partial or complete response.

Determine the 1 year survival rate of patient who received treatment.

Takara Bio Inc.

Digestive System Diseases

Gland and Hormone Related Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Paclitaxel

Tegafur

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

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.

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

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

Nab-paclitaxel

TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.

TS-1

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.

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

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.

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

Evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

Overall tumor response evaluated by RECIST version 1.1

Overall tumor response evaluated by irRECIST.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma	NCT03153085	Melanoma Stage ... Melanoma Stage ...	TBI-1401(HF10) Ipilimumab	20 Years -	Takara Bio Inc.
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients With Unresectable Pancreatic Cancer.	NCT03252808	Pancreatic Canc... Pancreatic Canc...	TBI-1401(HF10) Gemcitabine Nab-paclitaxel TS-1	20 Years -	Takara Bio Inc.

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