Advanced Malignant Solid Tumors
Conditions
Interventions
Group 1:Local injection in the tumor single time
Group 2:Local injection in the tumor multiple times
Group 3:Intravenous injection single time
Group 4:Intravenous injection multiple times
Group 5:Local injection of chest/abdominal single time
Group 6:Local injection of chest/abdominal multiple times
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~80 (inclusive), gender is not limited; 2. patients with advanced malignant solid tumors confirmed by histology or cytology, standard treatment failure, or no standard treatment plan, or current standard treatment is not suitable; 3. At least one tumor lesion that is evaluable in accordance with RECIST V.1.1; 4. At least one injectable, superficial lesion that is measurable and non-ruptured in accordance with RECIST V1.1 (only for intratumoral injection studies); 5. The investigator assessed the presence of cancerous thoracic/ascites (only for chest/abdominal local injection studies); 6. ECOG physical score 0-1 points (can be relaxed to 2 points in patients with cancerous chest and ascites participating in the chest/abdominal injection study); 7. serum HSV-1 antibody IgG positive; 8. Qualified patients (male and female) who have fertility must agree to use reliable contraceptive methods (hormone or barrier or abstinence) with their partners during the trial and at least 90 days after the last dose; female patients of childbearing age are selected before the election. The blood pregnancy test within the day must be negative; 9. Subjects must give informed consent to the study prior to the trial and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received anti-tumor drugs such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first use of the study drug; 2. Have undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or require elective surgery during the trial; 3. used anti-HSV drugs within 1 week prior to the first use of the study drug; 4. The adverse reactions of previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation =1; 5. Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that patients with central nervous system metastasis or meningeal metastases have not been controlled, the investigators judged that it is not suitable for enrollment; 6. In the recurrent infection period of herpes simplex virus, and there are corresponding clinical manifestations, such as herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes, etc.; 7. Have a history of immunodeficiency, including HIV antibody test positive; 8. Patients with active, or have had, and may have recurrent autoimmune diseases, except for patients with clinically stable autoimmune thyroid disease; 9. Had received immunotherapy and had an irAE rating of >=3; 10. Pregnant or lactating women; 11. The investigator believes that the subject has other reasons and is not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug biodistribution and virus shedding;Cytokine;Lymphocyte classification;PD-1 antibody;Anti-drug antibody;Antinuclear antibody;HSV-1 neutralizing antibody; | — |
Countries
China
Contacts
Public ContactLi Jin
Shanghai East Hospital
Outcome results
None listed