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

NCT03252808 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: TBI1401-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Pancreatic Cancer Stage III; Pancreatic Cancer Stage IV

Keywords

Unresectable pancreatic cancer; Metastatic pancreatic cancer; Pancreatic adenocarcinoma; TBI-1401(HF10); HF10; Oncolytic virus; Oncolytic viral immunotherapy; Gemcitabine; Nab-paclitaxel; Albumin-bound paclitaxel; Abraxane; Tegafur-gimeracil-oteracil potassium; TS-1; canerpaturev

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (5)

• Adverse Events (AEs)

  Through 1st TBI-1401(HF10) injection to study completion (up to 13 month).

• Objective response rate (ORR) by RECIST

  At 16 weeks and through study completion (up to 1 year).

• Objective response rate (ORR) by irRECIST

  At 16 weeks and through study completion (up to 1 year).

• Progression-free survival (PFS) by RECIST

  Through disease progression (up to 1 year).

• Progression-free survival (PFS) by irRECIST

  Through disease progression (up to 1 year).

Other Outcomes (2)

• Overall survival (OS)

  From 1st treatment to death (up to 2 years).

• 1 year survival rate

  for 1 year.

Study Arms (3)

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.

Biological: TBI-1401(HF10); Drug: Gemcitabine; Drug: Nab-paclitaxel

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.

Biological: TBI-1401(HF10); Drug: TS-1

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.

Biological: TBI-1401(HF10); Drug: TS-1

Interventions

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.

Also known as: HF10, canerpaturev

TBI-1401(HF10) + Gem/nab-PTX; TBI-1401(HF10) + TS-1 (primary and meta); TBI-1401(HF10) + TS-1 (primary)

Gemcitabine DRUG

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

Also known as: Gemzar

TBI-1401(HF10) + Gem/nab-PTX

Nab-paclitaxel DRUG

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

Also known as: Abraxane

TBI-1401(HF10) + Gem/nab-PTX

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.

Also known as: Tegafur-gimeracil-oteracil potassium

TBI-1401(HF10) + TS-1 (primary and meta); TBI-1401(HF10) + TS-1 (primary)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed unresectable pancreatic cancer (stage III or IV) based on the General Rules for the Study of Pancreatic Cancer (The 7th edition), and never received anti-cancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, clinical trials).
• 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.

You may not qualify if:

• Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10) treatment (except local treatment such as ointment).
• 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.

Sponsors & Collaborators

• Takara Bio Inc.: lead

Study Sites (8)

Clinical Site

Nagoya, Aichi-ken, Japan

Location

Clinical Site

Chiba, Chiba, Japan

Location

Clinical Site

Kashiwa, Chiba, Japan

Location

Clinical Site

Yokohama, Kanagawa, Japan

Location

Clinical Site

Osaka, Osaka, Japan

Location

Clinical Site

Chūōku, Tokyo, Japan

Location

Clinical Site

Koto-Ku, Tokyo, Japan

Location

Clinical Site

Nagoya, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; titanium silicide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Takara Bio Inc.

  Clinical Development & Strategy Division 2

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 17, 2017
• Study Start: September 25, 2017
• Primary Completion: February 19, 2020
• Study Completion (Estimated): March 31, 2035
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)