Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07382531

OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2026-02-04

30

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

BS008-001 is a multicenter, open-label phase Ib /II trial in heavily pre-treated patients with advanced solid tumors. Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀/mL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀/mL), with identical volumes being injected at the same lesion. The primary endpoint is safety and tolerability; secondary endpoints included efficacy outcomes assessed by RECIST 1.1/iRECIST.

CONDITIONS

Official Title

OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with unresectable stage III or IV malignant tumors confirmed by pathology and/or cytology, including malignant melanoma, head and neck tumors, soft tissue sarcoma, liver tumors (primary hepatocellular carcinoma or metastases), biliary tract tumors, pancreatic cancer, esophageal cancer, gastric cancer, etc.
  • Lack of effective standard treatment options or failure/relapse after standard treatments.
  • Male or female patients aged 18 to 75 years inclusive; ECOG performance status score of 0-1; expected survival over 3 months.
  • At least 4 weeks since completion of prior antitumor therapies (endocrine, chemotherapy, radiotherapy, targeted therapy) except radiotherapy for bone metastases; 6 weeks for nitrosoureas or mitomycin; prior treatment-related adverse effects recovered to Grade 1 or lower.
  • At least 4 weeks post-major surgery.
  • At least one measurable target lesion per RECIST 1.1 suitable for intratumoral injection (longest diameter ≥10 mm, lymph nodes short-axis diameter ≥15 mm).
  • No severe dysfunction of major organs.
  • Laboratory test values within specified limits for blood cells, kidney and liver function, and coagulation.
  • Female subjects and partners must use effective contraception during and for 3 months after treatment.
  • Genital herpes resolved for at least 3 months.
  • Voluntary informed consent with expected good compliance.
Not Eligible

You will not qualify if you...

  • Serious medical diseases such as uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.
  • Significant cardiovascular or cerebrovascular diseases including severe heart disease needing treatment, NYHA class III or IV heart failure, unstable angina, recent myocardial infarction within 6 months, prolonged QTc on ECG, severe arrhythmias requiring treatment, recent cardiac stent placement (within 6 months), uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg).
  • Uncontrolled primary brain tumors or brain metastases.
  • Bone metastases except stable and controlled after treatment; active symptomatic brain metastases.
  • Active autoimmune diseases requiring systemic treatment within past 2 years.
  • History of immunodeficiency or organ transplantation.
  • Uncontrolled psychiatric disorders or infectious diseases.
  • Active hepatitis B or C infection with detectable viral load.
  • Positive HIV test.
  • Active tuberculosis or other infectious diseases requiring systemic treatment.
  • Large symptomatic pleural effusion or ascites.
  • Pregnant or breastfeeding women.
  • Use of other investigational drugs or antiviral therapies within 4 weeks prior to treatment (except certain continuous hepatitis B treatments).
  • Participation in another clinical study within past 4 weeks.
  • Allergy to herpes viruses or study drug components.
  • Any condition judged by the investigator as unsuitable for trial participation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

J

Juan Zeng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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