OH2 and BS006 injections for advanced solid tumors

An Open-label, Dose-escalation Phase Ib/II Clinical Trial of Intratumoral Injection of OH2 Injection in Combination With BS006 Injection for the Treatment of Advanced Solid Tumors.

This study tests whether giving OH2 followed by BS006 directly into tumors is safe and can help people with advanced solid tumors who have already had other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Binhui Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07382531 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label phase Ib/II trial enrolled heavily pretreated patients with unresectable stage III/IV solid tumors and delivered biweekly sequential intratumoral injections of OH2 (fixed dose 10^7 CCID50/mL) followed by BS006 with dose escalation from 10^6 to 10^7 CCID50/mL into the same lesion. The primary goal was to determine safety and tolerability, with secondary efficacy outcomes measured by RECIST 1.1 and iRECIST. Eligible patients had at least one accessible lesion for injection, ECOG 0–1, and an expected survival beyond three months. Dosing, injection site procedures, and response assessments were standardized and monitored across participating centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with unresectable stage III/IV solid tumors who have exhausted standard treatments, have at least one accessible lesion for intratumoral injection, an ECOG performance status of 0–1, and expected survival over three months.

Not a fit: Patients without accessible injectable lesions, those with poor performance status or very limited life expectancy, or those who still have effective standard treatment options available are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could provide a new local immunotherapy that shrinks injected tumors and potentially triggers broader anti-tumor immune responses.

How similar studies have performed: Other early-phase studies using intratumoral oncolytic agents and sequential immune-modulating injections have shown promising signals in some tumor types but remain experimental and unproven in larger trials.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Juan Zeng

Conditions Solid Tumor