A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours.

This is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. administration; Part 2 is a dose escalation study of iv. and it. administration.

Inclusion Criteria: 1. Be willing to sign the ICF, be able to understand the study, and be willing to follow the protocol and complete all the study procedures; 2. Males or females aged ≥18 years when signing the ICF; 3. Patients with advanced solid tumors (including but not limited to melanoma, squamous cell carcinoma of head and neck, cervix carcinoma, bone sarcoma, nasopharyngeal cancer, breast cancer, lung cancer, colorectal cancer, hepatic cancer, and gastric cancer) as histopathologically or cytologically confirmed by primary lesions and/or metastases; Patients with unresectable locally advanced disease will be included, while patients with resectable disease will be excluded. 4. Patients who experienced treatment failure to standard of care, have no available standard of care, or are not suitable for standard of care due to medical reasons. Patients need to have progressed on at least two lines of standard of care therapy including but not limited to targeted therapy. For example, patients with metastatic or unresectable advanced melanoma who experienced treatment failure to standard of care such as anti-PD-1 antibody (patients harboring BRAF mutations who experienced treatment failure to BRAF and MEK inhibitors); patients with recurrent or metastatic advanced squamous cell carcinoma of head and neck who may have experienced standard treatment failure approved to anti-PD-1 monoclonal antibody and platinum-based chemotherapy; patients with recurrent or metastatic osteosarcoma who experienced treatment failure to chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); patients with colorectal cancer who have received standard of care fluoropyrimidine, oxaliplatin, Bevacizumab, and irinotecan-based chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor; patients with breast cancer (including HR positive, HER2 +, and triple negative breast cancer) who have received at least 2 prior lines which should include taxane and/or anthracycline-based therapy where appropriate and an approved checkpoint inhibitor; 5. Patients with at least one measurable lesion per RECIST v1.1, i.e., the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to computed tomography (CT) or magnetic resonance imaging (MRI); The patient should also have injected tumor lesions for Part 2, including cutaneous or subcutaneous visible nodal lesions or lesions palpable deemed injectable, and hepatic lesions or non-subcutaneous lymph nodes such as retroperitoneal. These lesions should be deemed feasible for injection either directly (palpable subcutaneous tumors) by a qualified investigator or under CT or ultrasound guidance (based on size, location, and visibility); All injected tumors should be \> 1 cm in size; 6. Patients with an ECOG score of 0-1 and an expected survival of at least 12 weeks; 7. Patients with adequate organ and hematopoietic function: ANC ≥1.5×10 9/L; Platelet count ≥75×10 9/L (no platelet transfusion or thrombopoietin \[TPO\] within 2 weeks prior to the first dose); Haemoglobin ≥90 g/L (no blood transfusion within 2 weeks); Serum creatinine ≤1.5×ULN or endogenous creatinine clearance (CCr) ≥50 mL/min; AST and ALT ≤3.0×ULN; AST and ALT ≤5×ULN for patients with liver metastases; Serum TBIL ≤2×ULN; International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN; 8. Female patients of childbearing potential must have a negative pregnancy test result within 7 days prior to the study treatment; 9. Male patients of reproductive potential and female patients of childbearing potential must agree to use a reliable contraceptive method during the study and at least 6 months after the last dose. Exclusion Criteria: 1. Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or who have been clinically stable for more than 3 months after local treatment can be enrolled); 2. Patients who received radiotherapy for the target lesion in the past 2 months; 3. Patients with other active malignancies in the past 5 years shall be excluded, with the exceptions for those who are completely cured and do not require follow-up treatment, and those with study indications; 4. The longest diameter of the injected lesion is \>100 mm for Part 2; 5. Patients participated (in the past 4 weeks) or are participating in clinical studies of the other drugs or medical devices; 6. Patients who plan to receive or received tissue or organ transplant; 7. Patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency (AID)-related opportunistic infection within 12 months, or CD4+ T-cell (CD4+) count \