Solid TumorPhase 1NCT02428036
A Study of TBI-1401(HF10) in Patients With Solid Tumors With Superficial Lesions
A Phase 1 study testing TBI-1401(HF10) in people with Solid Tumor, run by Takara Bio Inc. at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of solid tumors with superficial lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- TBI-1401(HF10)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 must have histologically confirmed solid tumors with superficial lesions.
- Patients must have unresectable and standard therapies-resistant solid tumors.
- Patients must be ≥ 20 years of age.
- Patients must have a life expectancy ≥ 12 weeks.
- Patients must have measurable non-visceral lesion(s) that are evaluable by the mWHO response criteria.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
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- Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined as
- Absolute neutrophil count ≥ 1,500/μL.
- Platelet count ≥ 100,000/μL.
- Total bilirubin levels ≤ 1.5 x upper limit of normal (ULN).
- AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present.
- creatinine ≤ 1.5 x ULN.
- creatinine clearance (calculated) ≥ 60 mL/min/1.73 m^2 for patients with creatinine > 1.5 x ULN.
- Patients must have passed 4 weeks after the completion of prior therapy [except bone metastasis therapy], or passed 8 weeks if immuno checkpoint inhibitor was treated.
- Patients must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
- Patients with Grade 2 adverse events Grade 2 or greater, except alopecia, resulting from anticancer agents administered more than 4 weeks prior to TBI-1401(HF10) administration.
- Patients receiving anti-herpes medication [except local treatment such as ointment].
- Patients receiving steroids or immunosuppressive agents [except inhaled steroid].
- Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection.
- Patients receiving anti-platelet medication.
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- Patients receiving anti-coagulation medication.
- Patients with presence or medical history of central nervous system metastasis.
- Patients with Grade ≥ 2 pre-existing neurologic abnormalities (CTCAE version 4.0).
- Patients with severe cardiac disorder or abnormal cardiac rhythm.
- Patients with psychiatric disorder or drug dependency which affects informed consent.
- Pregnant or breastfeeding women; women or men, having normal reproductive potential, who disagree with the protection of pregnancy within the timeframe of the study.
- Patients received any other investigational products within 4 weeks, or within 8 weeks if immuno checkpoint inhibitor was treated.
- Patients would limit compliance with study requirements, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Repeated Intratumoral Administration of TBI-1401(HF10), a Replication Competent HSV-1 Oncolytic Virus, in Patients With Solid Tumors With Superficial Lesions
The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of solid tumors with superficial lesions.
Read the detailed description
This is an open label, non-randomized, dose escalation Phase I study evaluating the repeated intratumoral administrations of the TBI-1401(HF10), a spontaneously attenuated mutant of HSV-1, in patients with solid tumors with superficial lesions (e.g., malignant melanoma and squamous cell carcinoma of the skin).
The study will evaluate the safety and tolerability of repeated intratumoral administrations of TBI-1401(HF10) at dose levels of 1 x 10^6 TCID50/dose (cohort 1) and 1 x 10^7 TCID50/dose (cohort 2) in Japanese patients. Three patients will be enrolled in each cohort. Patients in the each cohort will receive a total of four intratumoral administrations in the same lesion.
- Conditions
- Solid Tumor
- Being tested
- TBI-1401(HF10)
- Keywords
- TBI-1401(HF10), HF10, HSV-1, Oncolytic virus, Oncolytic virotherapy, Phase I, Melanoma, Intratumoral administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBI-1401(HF10)Biological
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^6 TCID50/mL.
TBI-1401(HF10)Biological
Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^7 TCID50/mL.
| Study group | Role | What they receive |
|---|---|---|
| TBI-1401(HF10) - Cohort 1 | Experimental | Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10) Receives: Biological: TBI-1401(HF10) |
| TBI-1401(HF10) - Cohort 2 | Experimental | Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10) Receives: Biological: TBI-1401(HF10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (CTCAE version 4.0).
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
Measured: up to Week 16
Secondary outcomes (2)
Overall tumor response (modified World Health Organization response criteria)
Overall tumor response will be evaluated by modified World Health Organization (mWHO) response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
Measured: at Week 12
Levels of antibody to HSV-1
Anti-HSV-1 antibodies will be assessed in serum.
Measured: up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takara Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naoya Yamazaki, Principal investigator, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428036
- Sponsor's protocol ID
- TBI1401-01
- Status last verified
- Jun 2017
- First submitted
- 16 Apr 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Repeated Intratumoral Administration of TBI-1401(HF10), a Replication Competent HSV-1 Oncolytic Virus, in Patients With Solid Tumors With Superficial Lesions
- ClinicalTrials.gov ID
- NCT02428036
- Acronym / sponsor ID
- TBI1401-01
- Conditions
- Solid Tumor
- Keywords
- TBI-1401(HF10), HF10, HSV-1, Oncolytic virus, Oncolytic virotherapy, Phase I, Melanoma, Intratumoral administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Takara Bio Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of solid tumors with superficial lesions.
Detailed description
This is an open label, non-randomized, dose escalation Phase I study evaluating the repeated intratumoral administrations of the TBI-1401(HF10), a spontaneously attenuated mutant of HSV-1, in patients with solid tumors with superficial lesions (e.g., malignant melanoma and squamous cell carcinoma of the skin).
The study will evaluate the safety and tolerability of repeated intratumoral administrations of TBI-1401(HF10) at dose levels of 1 x 10^6 TCID50/dose (cohort 1) and 1 x 10^7 TCID50/dose (cohort 2) in Japanese patients. Three patients will be enrolled in each cohort. Patients in the each cohort will receive a total of four intratumoral administrations in the same lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI-1401(HF10) - Cohort 1 | Experimental | Biological: TBI-1401(HF10)Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10) |
| TBI-1401(HF10) - Cohort 2 | Experimental | Biological: TBI-1401(HF10)Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed solid tumors with superficial lesions.
- Patients must have unresectable and standard therapies-resistant solid tumors.
- Patients must be ≥ 20 years of age.
- Patients must have a life expectancy ≥ 12 weeks.
- Patients must have measurable non-visceral lesion(s) that are evaluable by the mWHO response criteria.
Key exclusion criteria (14 listed)
- Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
- Patients with Grade 2 adverse events Grade 2 or greater, except alopecia, resulting from anticancer agents administered more than 4 weeks prior to TBI-1401(HF10) administration.
- Patients receiving anti-herpes medication [except local treatment such as ointment].
- Patients receiving steroids or immunosuppressive agents [except inhaled steroid].
- Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBI-1401(HF10)Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^6 TCID50/mL. | Biological | TBI-1401(HF10) - Cohort 1 |
| TBI-1401(HF10)Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^7 TCID50/mL. | Biological | TBI-1401(HF10) - Cohort 2 |
Primary outcome
Safety and tolerability (CTCAE version 4.0).
Time frame: up to Week 16
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
2 secondary outcomes
Overall tumor response (modified World Health Organization response criteria)
Time frame: at Week 12
Levels of antibody to HSV-1
Time frame: up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoya Yamazaki principal investigator
National Cancer Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBI-1401(HF10) in people with Solid Tumor, run by Takara Bio Inc. at 1 site 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (CTCAE version 4.0). (time frame: up to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.