Clinical trial · Interventional
A Study of TBI-1401(HF10) in Patients With Solid Tumors With Superficial Lesions
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
NCT02428036CI-TRIAL-00028368completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TBI-1401(HF10) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TBI-1401(HF10) - Cohort 1
- description
- Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)
- interventionNames
- Biological: TBI-1401(HF10)
- type
- EXPERIMENTAL
- label
- TBI-1401(HF10) - Cohort 2
- description
- Oncolytic virotherapy, intratumoral administrations of TBI-1401(HF10)
- interventionNames
- Biological: TBI-1401(HF10)
Primary outcomes (1)
- measure
- Safety and tolerability (CTCAE version 4.0).
- timeFrame
- up to Week 16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.