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Genital Diseases

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Muromonab-CD3

Three subjects will be enrolled in this cohort. First subject will receive first injection in dose level of 1 million CCID50/mL. If tolerated, second injection for this subject will be accelerated to 10 millions CCID50/mL. If tolerated, the third injection will be further accelerated to 100 million CCID50/mL. The maximum volume for per injection time point is 8 mL. Injection will repeat every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. If dose limiting toxicity (DLT) happens in any dose level, the injection dose will be decrease to the last tolerable level.

Fifteen subjects will be enrolled in this cohort. The maximal tolerable dose (MTD) confirmed in the first stage will be utilized in 15 patients. This stage should not be initiated before the completion of dose escalation of all three subjects in the first stage. Treatment will be repeated every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death. Dose interruption, not reduction, is permitted. Treatment will be terminated if toxicity-related treatment interrupt is longer than 28 days. Radiology assessment will be conducted every six weeks.

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.

BS-006

Shaoxing Sun, M. D.

Shaoxing Sun

Hui Qiu, Ph.D.

Shaoxing Sun, M.D.

Sufang Tian, Ph.D

Chunxu Yang, Ph.D.

Qingming Xiang, Ph.D.

Zijie Mei, Ph.D.

Min Chen, M.M.

Hui Qiu, Ph. D.

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.

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strain are planed to be injected into the tumor every two weeks until disease progression or unacceptable toxicity or withdrawn of consent or no lesion suitable for injection or death.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.

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

The dose level at which there is no more than one DLT happens in dose-escalation stage

The incidence of adverse events and severity graded according to CTCAE 5.0

Detection of BS-006 virus copy numbers in urine, stool, saliva, blood and wiper of injection point and perineum

Tumor change assessed by investigator according to RECIST 1.1

Rate of subjects who showed tumor shrinkage for any untreated lesion

Proportion of participants without tumor recurrence or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	NCT05393440	Uterine Cervica...	BS-006	18 Years - 75 Years	Zhongnan Hospital

Spots Global Cancer Trial Database for oncolytic viruses