oHSV2-PD-L1/CD3-BsAb Administered Via Intratumoral Injection

NCT05938296 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: BH-BS006-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of BS006 in patients with advanced solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)

  Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

  Through study completion, an average of about 1 year(a maximum treatment duration of one year)

• MTD

  To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BS006

  up to 1 year

Secondary Outcomes (5)

• ORR

  up to 1 year

• DCR

  up to 1 year

• Biological activity

  up to 1 year

• Biodistribution

  3 months

• Viral shedding

  3 months

Study Arms (1)

BS006 injection

EXPERIMENTAL

Subjects will receive BS006 every two weeks, and up to 4mL BS006 will be given. BS006 will be given intratumorally.

Drug: BS006 Injection

Interventions

BS006 Injection DRUG

BS006 will be given every two weeks, and up to 4mL in each treatment. There will be three dose levels: 1×10\^6 CCID50/mL, 5×10\^6 CCID50/mL, 1×10\^7 CCID50/mL.

Also known as: oHSV2-PD-L1/CD3-BsAb

BS006 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 18 years old.
• Subject must have histologically-only or histologically and cytologically confirmed diagnosis of solid tumors with palpable, visible or ultrasound detectable lesions (e.g., malignant melanoma, cutaneous squamous cell carcinoma and carcinoma of the breast).
• Subjects with tumors that are only confirmed by cytology are not eligible for this trial. Part 2 will only enroll subjects with advanced melanoma or CSCC.
• Subject must have received and failed all available standard-of-care (SOC) therapies.
• Subjects who are intolerant to treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment will also be eligible for this study.
• Subject has measurable disease as determined by RECIST version 1.1. At least 1 lesion must be suitable for intratumoral injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
• Melanoma patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) are eligible after discontinuing the last dose of previous T-Vec treatment for ≥ 12 weeks before first dose of IP.
• Subjects who have progressed on or are ineligible for available standard therapy are eligible for this trial after the last dose of the previous treatment which is ≥ 4 weeks or 5 half-lives(if required), whichever is longer before the first dose of study treatment.
• Subject has a predicted life expectancy of ≥ 12 weeks.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment.Female subject must agree not to breastfeed from screening, throughout the study period and 180 days after the final study drug administration.
• Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment.
• Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
• Subject agrees not to participate in another interventional study while receiving study drug.
• Subject has the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant.
• Subject has had major surgery ≤ 4 weeks of screening.
• Subject is concurrently participating in another interventional study or has received an investigational product ≤ 30 days or 5 half-lives prior to first study drug administration.
• Subject with symptomatic central nervous system (CNS) metastases, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months and have been off steroids for at least 4 weeks prior to first IP administration.
• Subject with active autoimmune disease requiring systemic therapy within past 2 years (e.g., systemic lupus erythematosus, Wegener syndrome (granulomatosis with polyangiitis),
• Graves' disease, hypophysitis, etc,). The following are exceptions to this criterion:
• Subject with vitiligo or alopecia
• Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Childhood asthma that has resolved
• Any chronic skin condition that does not require systemic therapy
• Type 1 diabetes mellitus ※Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Subject with another malignancy that currently requires treatment.
• Subject with tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for AEs or otherwise not considered appropriate for IT injection.
• Subject with inadequate organ and marrow functions meeting any of the below criteria:
• Leukocytes \< 3000/μL

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 10, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)