OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

Binhui Biopharmaceutical

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Biological: OH2+BS006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07382531

BS008-001

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with unresectable stage III or IV malignant tumors confirmed by pathology and/or cytology; such as malignant melanoma, head and neck tumors, soft tissue sarcoma, liver tumors (primary hepatocellular carcinoma or liver metastases), biliary tract tumors, pancreatic cancer, esophageal cancer, gastric cancer, etc.

• 2. Lack of standard effective treatment options, or failure of or relapse after standard treatments.

• 3.Male or female patients aged 18-75 years (inclusive); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; expected survival of more than 3 months.

• 4. At least 4 weeks have elapsed since completion of prior antitumor therapies (including endocrine therapy, chemotherapy/radiotherapy, and targeted therapy) (except radiotherapy for bone metastases); for patients treated with nitrosoureas or mitomycin, at least 6 weeks since discontinuation; and recovery from prior treatment-related adverse effects to Grade 1 or lower.

• 5. Patients who have undergone major surgery must be at least 4 weeks post-operation.

• 6. According to RECIST 1.1 criteria, at least one measurable target lesion is required, with a lesion suitable for intratumoral injection. A measurable tumor lesion is defined as having a longest diameter ≥10 mm with a scan slice thickness ≤5.0 mm; for lymph node lesions, a short-axis diameter ≥15 mm.

• 7. No severe dysfunction of major organs.

• 8. Laboratory tests:

  1. White Blood Cell (WBC) ≥3.0×10⁹/L, Absolute Neutrophil Count (ANC) ≥2.0×10⁹/L, Hemoglobin (Hb) ≥90 g/L; Platelet (PLT) ≥100×10⁹/L; absolute lymphocyte count (ALC)≥0.8×10⁹/L;
  2. Blood urea nitrogen (BUN) and serum creatinine ≤1.5× the upper limit of normal (ULN);
  3. Total bilirubin (TBIL) ≤1.5× ULN (for patients with hepatic involvement, TBIL ≤3× ULN);
  4. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5× ULN; for patients with liver metastases, ≤5× ULN;
  5. Normal coagulation function (Prothrombin Time, APTT, and Thrombin Time ≤1.5× ULN).

• 9. Female subjects and their partners must use effective contraception during treatment and for 3 months after treatment.

• 10. Subjects with genital herpes must have completed herpes resolution for at least 3 months.

• 11. Voluntary signing of the informed consent form, with expected good compliance.

Exclusion criteria

• 1. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.

• 2. Presence of clinically significant cardiovascular or cerebrovascular disease, including:

  1. Severe or uncontrolled heart disease requiring treatment, congestive heart failure classified as New York Heart Association (NYHA) class III or IV, unstable angina not controlled by medication, a history of myocardial infarction within the past 6 months, Corrected QT Interval (QTc) on Electrocardiogram (ECG) ≥450 ms in males or ≥470 ms in females, or severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia);
  2. Placement of a cardiac stent within the past 6 months;
  3. Inadequately controlled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.

• 3.Uncontrolled primary brain tumors or brain metastases.

• 4. Bone metastases (except for bone metastases that are stable and controlled after treatment), or the presence of active, clinically symptomatic brain metastases.

• 5. Active autoimmune diseases requiring systemic treatment within the past 2 years (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, etc., such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency) is not considered a systemic treatment.

• 6. History of immunodeficiency (HIV antibody-positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.

• 7. Uncontrolled psychiatric disorders or infectious diseases. Lesions that do not meet the volume requirements for intratumoral injection.

• 8. Patients with active hepatitis B or hepatitis C infection: those who are HBsAg-positive or HBcAb-positive with detectable HBV DNA copies (lower limit of quantification: 500 IU/mL); HBV DNA testing is mandatory at screening for such patients. Patients with a positive anti-HCV antibody test are eligible only if HCV RNA PCR testing is negative.

• 9. Positive HIV test result.

• 10. Presence of active tuberculosis infection or other infectious diseases requiring systemic treatment.

• 11. Large amounts of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment.

• 12. Pregnant or breastfeeding women.

• 13. Use of, or ongoing treatment with, other investigational drugs or antiviral therapies within 4 weeks prior to treatment, except that patients with chronic hepatitis B receiving continuous treatment may use entecavir, tenofovir disoproxil fumarate, or adefovir dipivoxil.

• 14. Participation in another clinical study within the past 4 weeks.

• 15. Known allergy to herpes viruses or any components of the study drug.

• 16. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

OH2+BS006

Experimental group

Description:

The administration method consists of sequential intratumoral injections of OH2 and BS006 at an equal volume ratio. Administration occurs once every 2 weeks (Q2W) until the investigator determines that the subject no longer derives clinical benefit and exhibits significant clinical disease progression (radiographic progression is not a mandatory criterion for treatment discontinuation), or until the treatment is no longer tolerated, or the clinical trial concludes. For each administration, subjects may receive a maximum of 6 mL each of OH2 Injection and BS006 Injection.

Treatment:

Biological: OH2+BS006