Advanced solid tumors
Conditions
Interventions
Experimental group:The volumes of VSV-01 and OVV-00 are determined based on the size of the tumor lesion. According to the guidelines, the maximum volume is given. The researchers evaluate the size of
Sponsors
The First Affiliated Hospital of Xinxiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, understand this study, be willing to follow the protocol and complete all trial procedures; 2. When signing the ICF, the age should be >= 18 years old, and gender is not restricted. 3. Late-stage solid tumor subjects diagnosed by pathological histology/cytology examination of the primary lesion and/or metastatic lesion. 4. Subjects who have failed standard treatment, are at the end-line stage and have no access to standard treatment due to medical reasons. 5. Subjects must have at least one measurable lesion according to the RECIST·1.1 standard. 6. ECOG performance status score of 0-2, and expected survival period of no less than 12 weeks. 7. Sufficient organ and hematopoietic functions. 8. Female subjects with fertility must undergo a pregnancy test 7 days before starting treatment and the result must be negative. 9. Male and female subjects with fertility must agree to use reliable contraceptive methods during the trial and for at least 6 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Subjects with known brain metastases and/or clinically suspected brain metastases (but asymptomatic brain metastases or those that have been clinically stable for more than 3 months after local treatment can be included); 2. Subjects whose target lesions have received radiotherapy within 2 months; 3. Subjects who have had other active malignant tumors within the past 5 years. Subjects who have been completely cured and do not require follow-up treatment are excluded, as are those with malignant tumors within the indication range; 4. The longest diameter of the injection site lesion is > 100 mm; 5. Subjects who have participated in or are currently participating in other clinical trials of drugs or medical devices within the past 4 weeks; 6. Subjects who are preparing for or have previously undergone organ/organ transplantation; 7. Subjects with human immunodeficiency virus (HIV) infection and opportunistic infections related to AIDS within 12 months, or with a CD4+ T-cell (CD4+) count = 3 grade active infections with significant clinical relevance; 11. Subjects who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, etc. as anti-tumor drugs within 4 weeks before the first administration; Subjects who received small molecule targeted therapy and oral fluorouracil drugs within 2 weeks before or 5 half-lives (whichever is longer) before the first administration; Subjects who received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first administration; Subjects who received nitrosourea or mitomycin C within 6 weeks before the first administration; Allow palliative radiotherapy of non-target lesions (first administration >= 2 weeks before); 12. Uncontrolled hypertension or pulmonary hypertension or unstable angina pectoris during the study period; Subjects who had myocardial infarction or bypass, stent surgery within 6 months before the administration; Subjects with a history of chronic heart failure of NYHA standard 3-4; Severe arrhythmias that require treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia judged by the investigator not to affect the trial) including QTcF for males >= 450ms, females >= 470ms (calculated by Fridericia formula); Subjects with cerebrovascular accidents (CVA) or transient ischemic attacks (TIA) or other cerebrovascular accidents within 6 months before enrollment; 13. Subjects with active autoimmune diseases or those with a history of autoimmune diseases that may recur; 14. Subjects who need to receive systemic corticosteroids (> 10mg/day prednisone or equivalent dose) or other immunosuppressive drugs during the study period within 14 days before the first administration; 15. Subjects with tumors located in high-risk areas (including in mucosal areas, or close to airways, major blood vessels or spinal cord),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity; | — |
Countries
China
Contacts
Public ContactWeiwei Li
The First Affiliated Hospital of Xinxiang Medical University
Outcome results
None listed