drugset / Trial / NCT05393440
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2022-09-16
- Primary completion
- 2023-12-31
- Completion
- 2024-07-01
Publications
- Background Mondal M, Guo J, He P, Zhou D. Recent advances of oncolytic virus in cancer therapy. Hum Vaccin Immunother. 2020 Oct 2;16(10):2389-2402. doi: 10.1080/21645515.2020.1723363. Epub 2020 Feb 20.
- Background Kohlhapp FJ, Kaufman HL. Molecular Pathways: Mechanism of Action for Talimogene Laherparepvec, a New Oncolytic Virus Immunotherapy. Clin Cancer Res. 2016 Mar 1;22(5):1048-54. doi: 10.1158/1078-0432.CCR-15-2667. Epub 2015 Dec 30.
- Background Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
- Background Raja J, Ludwig JM, Gettinger SN, Schalper KA, Kim HS. Oncolytic virus immunotherapy: future prospects for oncology. J Immunother Cancer. 2018 Dec 4;6(1):140. doi: 10.1186/s40425-018-0458-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BS006 | Unknown | 1e+06 unknown | Other |
| Subject | BS006 | Unknown | 1e+07 unknown | Other |
| Subject | BS006 | Unknown | 1e+08 unknown | Other |