First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer

Inclusion Criteria: 1. Older than 18 years old and younger than 75 years old; 2. Zubrod-ECOG-WHO performance status is 0-1; 3. Life expectancy is longer than 3 months; 4. Pathologically proven malignant tumor originating from cervix uterine. All pathological types are acceptable except for sarcoma of any subtypes; 5. Radiological confirmed progression after at least 2 lines prior treatment or intolerable toxicity events occur during the second or later line treatment: 1) Neoadjuvant or adjuvant chemotherapy for no less than 2 cycles should be regarded as a separate treatment line if disease progress within 6 months after treatment finish;2) Regional treatment such as brachytherapy, radiofrequency ablation and artery embolization therapy should not be considered as a treatment line; 3) Treatment shift due to toxicity without radiological progression should not be counted as a separate line; 6. At least one measurement lesion according to RECIST 1.1; 7. At least one lesion with maximum diameter is larger than 1cm and surgically accessibility; 8. Patients must have recovered from prior treatment related toxicity to CTCAE grade 1 or 0; 9. Time interval to last systematic treatment or radiation affecting more than 20% bone marrow must be more than 4 weeks; 10. Time interval to last major surgery must be more than 4 weeks; 11. Abundant organ function: 1) Absolute neutrophil count is more than 1500/mm3 without granulocyte colony stimulating factor in the prior 7 days or long-acting granulocyte colony stimulating factor in the prior 20 days; platelets count is more than 100,000/mm3 without thrombopoietic drugs in the prior 7 days or platelet transfusion in the prior 10 days; hemoglobin is more than 9.0g/dL without red blood cell transfusion in the prior 20 days; 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are lower than 2.5-fold upper limit of normal (ULN); serum bilirubin is lower than 1.5-fold ULN; serum albumin is more than 3g/dL; 3) Serum creatinine is lower than 1.5-fold ULN; 4) Prothrombin time and activated partial thromboplastin time is lower than 1.3-fold ULN; 12. Patients must have fully recovered from suspected or diagnosed genital herpes beyond 3 months; 13. Patients or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirement; 14. Women of childbearing potential must agree to use highly effective contraceptive methods in while on study drug and for at least 3 months after the last injection of BS-006. The pregnancy test within 7 days prior to the first injection must be negative. Exclusion Criteria: 1. Cervical sarcoma of any subtype or prior history of other malignancy within 5 years; 2. Central nerve system metastasis; 3. Lesions met the requirement outlined in the inclusion criteria are unsafe for injection evaluated by investigators; 4. Severe comorbidities of any organs, including but not limit to myocardial infarction within 6 months, unstable angina pectoris, congestive heart failure, grade 3 or higher hypertension per CTCAE, cardiac arrhythmias, uncontrolled diabetes, fever of unknown reason, active digest ulcer and chronic obstructive pulmonary disease; 5. History of central nervous system infectious or demyelinating disease; 6. Severe infectious disease requiring constant antibiotic treatment; 7. Systematic glucocorticoids use within 2 weeks or glucocorticoids need for a long term; 8. Active infection of hepatitis B or C, HIV, cytomegalovirus, syphilis or other virus requiring treatment; 9. Immune disorder disease; 10. Antiviral treatment of any kinds; 11. Prior participant in experimental viral therapy; 12. Allergy to herpes simplex virus vaccine; 13. Participation in another research study within 4 weeks; 14. Poor compliance or incapacitated patients due to mental illness or other reasons; 15. Pregnancy or lactation.