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Virus Therapy

BS006 injection for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Binhui Biopharmaceutical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is a type of research study called Phase 1, which means it is testing a new treatment on a small group of patients for the first time. The study will be done at multiple medical

Who is the study for?

This trial is for adults with advanced solid tumors, like melanoma or breast cancer, who can feel or see their tumor, or it's detectable by ultrasound. They should have tried all standard treatments without success, be intolerant to them, or refused them. Their disease must be measurable and they need a life expectancy of at least 12 weeks with good performance status.Check my eligibility

What is being tested?

The study tests BS006 Injection in patients with advanced solid tumors. It starts by finding the safest dose and then expands to more patients at that dose level. The focus is on safety, how well the body tolerates it, where the drug goes in the body (biodistribution), virus shedding from cells and initial signs of effectiveness.See study design

What are the potential side effects?

Since this is an early-phase trial for a new treatment, specific side effects are not listed but may include typical reactions related to immune therapies such as inflammation around the injection site, flu-like symptoms, fatigue and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis was not based solely on cell samples and I have advanced melanoma or CSCC.

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I am fully active or can carry out light work.

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My solid tumor can be felt, seen, or detected by ultrasound.

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I have tried and not responded to all standard treatments available for my condition.

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I have a tumor that can be measured and is the right size for an injection.

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I've either progressed after standard treatment or am ineligible for it, and it's been over 4 weeks or 5 half-lives since my last treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

MTD

Secondary outcome measures

Biodistribution

Biological activity

DCR

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BS006 injectionExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Binhui Biopharmaceutical Co., Ltd.Lead Sponsor

14 Previous Clinical Trials

1,110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enrolled in this research investigation?

"Indeed, the details provided on clinicaltrials.gov affirm that this investigation is actively seeking eligible participants. The study was initially posted on December 19th, 2023 and underwent its most recent revision on December 20th, 2023. A total of 29 patients are being sought for enrollment at a single designated site."

Answered by AI

What are the main goals that this medical study aims to achieve?

"The main focus of this trial is to determine the maximum tolerated dose (MTD), which will be assessed for approximately one year or until the completion of the study, whichever comes first. Secondary objectives include analyzing biodistribution by measuring BS006 DNA copy, evaluating biological activity through assessing mRNA expression in fine needle aspirate (FNA) of granulocyte macrophage colony stimulating factor PD-L1/CD3 bispecific antibody, and determining disease control rate (DCR) as a percentage based on participants' best overall response categorized as complete response (CR), partial response (PR), or stable disease (SD)."

Answered by AI

Has the BS006 injection received official endorsement from the FDA?

"Based on the assessment by our team at Power, the safety rating for BS006 injection is 1. This is due to it being a Phase 1 trial, which implies that there exists only limited data supporting both efficacy and safety of the intervention."

Answered by AI

Are patients currently able to participate in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking eligible participants. The study was initially posted on December 19th, 2023 and recently updated on December 20th, 2023. There are currently openings for a total of 29 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "oHSV2-PD-L1/CD3-BsAb Administered Via Intramural Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938296.