NCT05393440

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

A First-in-human Phase I Two-stage Clinical Trial for Intratumoral Injection of Recombinant Oncolytic Type II Herpes Simplex Virus (BS-006) in Patients With Recurrent Cervical Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial includes accelerated dose-escalation stage and dose-expansion stage. An engineered modification oncolytic viruses, BS-006, derived from type II herpes simplex virus strain are planed to be injected into the tumor every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. In dose-escalation stage, there are three dose levels (1 million, 10 millions, 100 millions 50 % cell culture infectious dose (CCID50)/ml) . Treatment dose will escalate to next higher level if no dose limiting toxicity happens for one time of injection in 3 subjects. Maximal tolerable dose is defined as the highest dose with no more than one dose limiting toxicity and is recommended for dose expansion stage. In dose-expansion stage, 15 subjects will be enrolled. BS-006 viruses will be injected into proper tumor lesions every 2 weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. Radiology assessment will repeat every 6 weeks. Dose interruption, not reduction, is permitted in this stage.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	BS-006	BS-006 is an engineered recombinant type II herpes simplex virus (HSV2) designed and produced by Wuhan Binhui Biopharmaceutical Co., Ltd. It was derived from HSV2 strain HG52. ICP34.5 and ICP47 genes were deleted to ensure abortive infection and immune destruction in normal cells. Bispecific T cell engager of anti-CD3 antibody and anti-PD-L1 antibody were constructed and inserted into HG52 strain genome.

Timeline

• Start date: 2022-09-16
• Primary completion: 2023-12-31
• Completion: 2024-07-01
• First posted: 2022-05-26
• Last updated: 2023-04-07

Locations

1 site across 1 country: China