A Study of TBI-1401(HF10) in Patients With Solid Tumors With Superficial Lesions

NCT02428036 | Completed Phase 1

• 1 other identifier: TBI1401-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Keywords

TBI-1401(HF10); HF10; HSV-1; Oncolytic virus; Oncolytic virotherapy; Phase I; Melanoma; Intratumoral administration

Outcome Measures

Primary Outcomes (1)

• 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).

  up to Week 16

Secondary Outcomes (2)

• Overall tumor response (modified World Health Organization response criteria)

  at Week 12

• Levels of antibody to HSV-1

  up to Week 12

Other Outcomes (4)

• Change in cytokine profiles in serum

  up to Week 12

• Change in antitumor T-cell reactivity in serum

  up to Week 12

• Change in regulatory T-cell (Treg) population in serum

  up to Week 12

Study Arms (2)

TBI-1401(HF10) - Cohort 1

EXPERIMENTAL

Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)

Biological: TBI-1401(HF10)

TBI-1401(HF10) - Cohort 2

EXPERIMENTAL

Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)

Biological: TBI-1401(HF10)

Interventions

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) - Cohort 1

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takara Bio Inc.: lead

Study Sites (1)

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Naoya Yamazaki

  National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 28, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

JP (1)