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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 25, 2017

Primary Completion Date

February 19, 2020

Study Completion Date

March 31, 2035

Conditions
Pancreatic Cancer Stage IIIPancreatic Cancer Stage IV
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.

Trial Locations (8)

Unknown

Clinical Site, Nagoya

Clinical Site, Chiba

Clinical Site, Kashiwa

Clinical Site, Yokohama

Clinical Site, Osaka

Clinical Site, Chūōku

Clinical Site, Koto-Ku

Clinical Site, Nagoya

All Listed Sponsors
lead

Takara Bio Inc.

INDUSTRY