Advanced solid tumors
Conditions
Interventions
Test group: intravenous injection of oncolytic virus (OVV-01) injection
Sponsors
SHANGHAI GENERAL HOSPITAL
Eligibility
Sex/Gender
All
Age
10 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 10 years old and = 75 years old, regardless of gender 2. Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary and/or metastatic lesions 3. Patients who have failed standard treatment and currently do not have standard treatment or are not suitable for standard treatment due to medical reasons 4. ECOG score is 0-2 5. Expected survival time = 3 months 6. Adequate bone marrow function 7. Adequate liver and kidney function 8. Adequate coagulation function 9. Adequate cardiovascular function 10. Pregnancy test results for women of childbearing age within 14 days before enrollment treatment were negative. 11. The patient voluntarily participated in this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) Subjects without measurable lesions; 2) Patients with known brain metastasis and/or clinically suspected tumor brain metastasis (but asymptomatic brain metastasis or clinically stable for more than 3 months after local treatment can be included); 3) Subjects who have undergone radiotherapy for the target lesion within 2 months; 4) Subjects with other active malignant tumors that require simultaneous treatment; 5) Within 4 weeks before administration, other experimental drugs were used, are currently being used, or are still needed for treatment; 6) Subjects who are preparing to undergo or have previously received tissue/organ transplantation; 7) The subject has an active infection or has an unexplained fever>38.5 ? during the screening period or before the first administration; 8) Patients with active pulmonary tuberculosis (TB) who are currently receiving anti tuberculosis treatment or have received anti tuberculosis treatment within one year prior to screening; 9) Positive serological test for Treponema pallidum; 10) Subjects known to have a positive history of human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS); 11) Active hepatitis B subjects 12) Within 4 weeks before the first administration, chemotherapy (including interventional embolization chemotherapy or interventional perfusion chemotherapy), radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor drug treatments have been received, 13) Cardiovascular system diseases 14) Patients with active autoimmune diseases or a history of autoimmune diseases that may recur 15) Patients need to use glucocorticoids within 14 days before the study drug administration 16) Subjects with mental illness, alcoholism, inability to quit smoking, drug use, or substance abuse; 17) Female subjects who are pregnant or breastfeeding, or are expected to become pregnant during the trial period (from screening visits until 180 days after administration), as well as male subjects who are expected to conceive their partners; 18) The adverse reactions of previous anti-tumor therapy have not yet recovered to (CTCAE 5.0) level 1 (excluding hair loss); 19) After being determined by the researchers to have a serious uncontrollable disease or other conditions that may affect the acceptance of treatment in this study, they are deemed unsuitable to participate in this study. 20) Other researchers believe that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT;MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, Objective Response Rate;Disease Control Rate;DOR, Duration of Response ;Progression-Free-Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactYingqi Hua
SHANGHAI GENERAL HOSPITAL
Outcome results
None listed