TBI-1401
- Conditions
- Solid tumors with superficial lesions
- Registration Number
- JPRN-jRCT2080222883
- Lead Sponsor
- TAKARA BIO INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 6
1) Patients must have histologically confirmed solid tumors with superficial lesions (>=10mm).
2) Patients must have unresectable and standard therapies-resistant solid tumors.
3) Patients must have a life expectancy >=12 weeks.
4) Patients must have measurable non-visceral lesion(s) that are evaluable by the mWHO response criteria.
5) Patients must have an ECOG performance status of 0,1, or 2.
6) Patients must have adequate organ function (bone marrow, heart, lung, liver, renal, etc) and must meet all the following criteria.
- Absolute neutrophil count >=1,500/uL.
- Platelet count >=100,000/uL.
- 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) >=60mL/min/1.73m^2 for patients with creatinine >1.5 x ULN).
7) 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.
8) Patients must be able to understand and willing to sign a written informed consent document.
1) Patients with a significant risk of tumor bleeding, or coagulation or bleeding disorders.
2) Patients with >=Grade 2 adverse events except for alopecia related to the prior therapy, which was performed 4 weeks or more before the scheduled date of TBI-1401(HF10) administration(Except for case in which adverse event caused by previous treatment is controlled by medication etc. and the investigator judges that the adverse event exerts on safety evaluation).
3) Patients receiving anti-herpes medication (except local treatment such as ointment).
4) Patients receiving systemic administration of steroids or immunosuppressive agents (except for steroid inhalation).
5) Patients positive for HBs antigen, HCV antibody or HIV antibody.
6) Patients receiving anti-platelet medication, which is difficult to be discontinued during the clinical trial.
7) Patients receiving anti-coagulation medication by which intratumoral injection or biopsy cannot be conducted safely.
8) Patients with presence or medical history of central nervous system metastasis.
9) Patients with Grade >=1 pre-existing neurologic abnormalities.
10) Patients with severe cardiac disorder or abnormal cardiac rhythm.
11) Patients with psychiatric disorder or drug dependency which affects informed consent.
12) Pregnant or breastfeeding women (except for the case of discontinuation without resumption); women or men, having normal reproductive potential, who disagree with contraception according to physician's instruction within the timeframe of the study.
13) Patients received any other investigational products within 4 weeks, or within 8 weeks if immuno checkpoint inhibitor was treated.
14) Any other patients judged by investigators to be inappropriate for the subject of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability<br>Adverse events (CTCAE ver4.0).<br>HF10 virus DNA (qPCR)
- Secondary Outcome Measures
Name Time Method Overall tumor response, Levels of antibody to HSV-1<br>Overall tumor response (mWHO response criteria)<br>Titer of Anti-HSV-1 antibodies in serum.