Advanced Solid Tumors
Conditions
Interventions
group 1:Dosage of RT-01: 1x10^7 TCID50/mL
group 2:Dosage of RT-01: 1x10^8 TCID50/mL
group 3:Dosage of RT-01: 7x10^8 TCID50/mL
Sponsors
the First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or female aged 18 years and over; 2.Subjects must have histologically or cytologically confirmed diagnosis of advanced solid tumor(s) who have failed in standard therapy (disease progression or intolerance) and no effective treatment, or have no standard therapy, or have failed to obtain standard treatment due to objective conditions ; 3.Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter >= 10 mm, or nodal lesions with short diameter >= 15 mm); 4.ECOG score of 0 - 2; 5.Adequate bone marrow, hepatic and renal and coagulation function; 6.Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug; 7.Voluntarily participated in this study, signed the informed.
Exclusion criteria
Exclusion criteria: 1.Subjects with known brain metastasis and/or clinically history tumor brain of metastasis; 2.Subjects who have received anti-tumor therapy such as chamotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration; 3.Subjects who have participate in another interventional study within 4 weeks before RT-01 administration; 4.Subjects who have had major surgery within 4 weeks before RT-01 administration; 5.Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids; 6.Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration; 7.Subjects receivd live vaccines within 7 days before RT-01 administration; 8.Subjects receivd Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration; 9.Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia); 10.Subjects who have uncontrolled active infection; 11.Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 12.Subjects who have active hepatitis, or hepatitis C (anti-HCV positive), or syphilis; 13.Subjects who have serious cardiovascular system disorders history; 14.Clinically uncontrollable third space effusion,are considered unsuitable for this study in the opinion of the investigator; 15.Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse, except for patients with clinically stable autoimmune thyroiditis; 16.Known to be alcohol or drug dependent; 17.Subjects with mental disorders or poor compliance; 18.Women who are pregnant or breastfeeding; 19.Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity, DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;progression-free survival;Overall Survival;the immunoreactivity;the immunogenicity;Pharmacokinetics characteristics of RT-01;the viral shedding;Adverse Event; | — |
Countries
China
Contacts
Public ContactWang Zishu
the First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed