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ACTIVE NOT RECRUITING
NCT03252808
PHASE1

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

Sponsor: Takara Bio Inc.

View on ClinicalTrials.gov

Summary

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.

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.

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2017-09-25

Completion Date

2035-03-31

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

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.

DRUG

Gemcitabine

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

DRUG

Nab-paclitaxel

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

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.

Locations (8)

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