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Pancreatic Cancer Stage IIIPhase 1NCT03252808

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

A Phase 1 study testing TBI-1401(HF10), Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Takara Bio Inc. at 8 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
TBI-1401(HF10), Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
8 sitesJapan
Study dates
25 Sep 2017to 31 Mar 2035
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Clinical Site

    Chiba, Chiba

  • Clinical Site

    Chūōku, Tokyo

  • Clinical Site

    Kashiwa, Chiba

  • Clinical Site

    Koto-Ku, Tokyo

  • Clinical Site

    Nagoya, Aichi-ken

  • Clinical Site

    Nagoya

  • Clinical Site

    Osaka, Osaka

  • Clinical Site

    Yokohama, Kanagawa

Other trials in Japan

About this study

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.

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.

Read the detailed description

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.

Being tested
TBI-1401(HF10), Gemcitabine, Nab-paclitaxel, TS-1
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
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TBI-1401(HF10)Biological

    Also called HF10, canerpaturev

    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.

  • GemcitabineDrug

    Also called Gemzar

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

  • Nab-paclitaxelDrug

    Also called Abraxane

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

  • TS-1Drug

    Also called Tegafur-gimeracil-oteracil potassium

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

Study groups in NCT03252808
Study groupRoleWhat they receive
TBI-1401(HF10) + Gem/nab-PTXExperimental1x10^6 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.
Receives: Biological: TBI-1401(HF10); Drug: Gemcitabine; Drug: Nab-paclitaxel
TBI-1401(HF10) + TS-1 (primary)Experimental1x10^6 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.
Receives: Biological: TBI-1401(HF10); Drug: TS-1
TBI-1401(HF10) + TS-1 (primary and meta)Experimental1x10^6 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.
Receives: Biological: TBI-1401(HF10); Drug: TS-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT)

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

    Measured: Through 1st TBI-1401(HF10) injection to before 3rd injection (basically 4 weeks).

Secondary outcomes (5)

  1. Adverse Events (AEs)

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

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

  2. Objective response rate (ORR) by RECIST

    Overall tumor response evaluated by RECIST version 1.1

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

  3. Objective response rate (ORR) by irRECIST

    Overall tumor response evaluated by irRECIST.

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

  4. Progression-free survival (PFS) by RECIST

    Evaluation the time to progression during and after the treatment.

    Measured: Through disease progression (up to 1 year).

  5. Progression-free survival (PFS) by irRECIST

    Evaluation the time to progression during and after the treatment.

    Measured: Through disease progression (up to 1 year).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2017
  2. Study start25 Sep 2017
  3. Primary completion19 Feb 2020
  4. Study completion31 Mar 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03252808
Sponsor's protocol ID
TBI1401-03
Status last verified
Dec 2024
First submitted
9 Aug 2017
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TBI-1401(HF10), Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Takara Bio Inc. at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: Through 1st TBI-1401(HF10) injection to before 3rd injection (basically 4 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03252808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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