Solid TumorPhase 1NCT05938296
oHSV2-PD-L1/CD3-BsAb Administered Via Intratumoral Injection
A Phase 1 study testing BS006 Injection in people with Solid Tumor, run by Binhui Biopharmaceutical Co., Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BS006 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2023to 19 Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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
- Absolute neutrophil count < 1500/μL (Subjects treated with G-CSF or GM-CSF within 14 days prior to screening will not be enrolled.)
- Platelets < 100,000/μL (Subjects with a platelet transfusion, or treated with TPO, TPO receptor agonist or IL11 within 14 days prior to screening will not be enrolled.)
- Hemoglobin (Hgb) < 9 g/dL (Subjects with a blood transfusion or treated with EPO within 14 days prior to screening will not be enrolled.)
- International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits
- Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 3.0 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits.
- Albumin <3.0 g/dL
- Estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m2 (It is calculated according to the CKD-EPI formula)
- Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study drug. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (e.g., subjects with active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis), or subjects requiring intermittent or chronic systemic (intravenous or oral) treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use), symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements, or a condition that could invalidate communication with the Investigator.
- Subject is known to be positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody, or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection.
- Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy, or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of BS006 is allowed.
- Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.
- Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia, or congestive heart failure (New York Heart Association grade ≥ 2).
- Subject who has a history of bleeding diathesis, are on anti-coagulation therapy, or have abnormal coagulation-fibrinolytic parameters (e.g., activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), and platelet count).
- Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia, or hypotension during or following treatment with BS006.
- Subject has a known or suspected hypersensitivity to BS006 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).
- Subject has had previous exposure with BS006
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, 48201
Orlando Health Cancer Institute
Orlando, Florida, 32806
About this study
Official title: A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors
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.
Read the detailed description
Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Patients must have histologically confirmed advanced and/or metastatic melanoma, cutaneous squamous cell carcinoma and other solid tumors with palpable, visible or ultrasound detectable lesions. Also, patients with solid tumors that are refractory to standard therapy and for which no existing conventional therapy are eligible. Melanoma patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive BS006.
The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (3 doses of BS006) and an optional extended treatment period (repeated every 2 weeks). Subjects will be treated for up to 12 months.
- Conditions
- Solid Tumor
- Being tested
- BS006 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BS006 InjectionDrug
Also called oHSV2-PD-L1/CD3-BsAb
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.
| Study group | Role | What they receive |
|---|---|---|
| BS006 injection | Experimental | Subjects will receive BS006 every two weeks, and up to 4mL BS006 will be given. BS006 will be given intratumorally. Receives: Drug: BS006 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 1 year
Secondary outcomes (5)
ORR
Determination of the ORR is calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and modified WHO response criteria as assessed.
Measured: up to 1 year
DCR
DCR is defined as the percentage of participants with a best overall response of CR, PR, or SD.
Measured: up to 1 year
Biological activity
Granulocyte macrophage colony stimulating factor PD-L1/CD3 bispecific antibody mRNA expression in fine needle aspirate (FNA)(Only for Part 1)
Measured: up to 1 year
Biodistribution
BS006 DNA copy
Measured: 3 months
Viral shedding
BS006 DNA copy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start19 Dec 2023
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Why it stopped: Strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binhui Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938296
- Sponsor's protocol ID
- BH-BS006-001
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05938296
- Acronym / sponsor ID
- BH-BS006-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Strategy adjustment
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Binhui Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Patients must have histologically confirmed advanced and/or metastatic melanoma, cutaneous squamous cell carcinoma and other solid tumors with palpable, visible or ultrasound detectable lesions. Also, patients with solid tumors that are refractory to standard therapy and for which no existing conventional therapy are eligible. Melanoma patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive BS006.
The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (3 doses of BS006) and an optional extended treatment period (repeated every 2 weeks). Subjects will be treated for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BS006 injection | Experimental | Drug: BS006 InjectionSubjects will receive BS006 every two weeks, and up to 4mL BS006 will be given. BS006 will be given intratumorally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (33 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BS006 InjectionAlso: oHSV2-PD-L1/CD3-BsAbBS006 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. | Drug | BS006 injection |
Primary outcome
Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)
Time frame: Through study completion, an average of about 1 year(a maximum treatment duration of one year)
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
MTD
Time frame: up to 1 year
To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BS006
5 secondary outcomes
ORR
Time frame: up to 1 year
DCR
Time frame: up to 1 year
Biological activity
Time frame: up to 1 year
Biodistribution
Time frame: 3 months
Viral shedding
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BS006 Injection in people with Solid Tumor, run by Binhui Biopharmaceutical Co., Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE (Adverse Event) and SAE (Serious Adverse Event) (time frame: Through study completion, an average of about 1 year(a maximum treatment duration of one year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.