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

NCT05393440 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-04-07

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Binhui Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Hui Qiu, Ph. D. · Wuhan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2023-12-31
Completion
2024-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393440 on ClinicalTrials.gov