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

Summary

This is a two-stage phase I clinical trial with oncolytic viruses BS-006 in recurrent or metastasis cervical cancer patients who failed in second line treatment.

Key Facts

Interventions

Conditions

Eligibility

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.

Outcome Measures

Locations