[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622354":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Binhui Biopharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OH2+BS006","EXPERIMENTAL","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.",[13],"Biological: OH2+BS006",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀\u002FmL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀\u002FmL), with identical volumes being injected at the same lesion.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Juan Zeng","CONTACT","+86 13971257652","zengjuan@binhui-bio.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Zhongnan Hospital of Wuhan University","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.26667,30.58333,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100622354","phase-1-oh2-injection-in-combination-with-bs006-injection-for-advanced-solid-tumors-100622354",false,"NCT07382531","OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors","An Open-label, Dose-escalation Phase Ib\u002FII Clinical Trial of Intratumoral Injection of OH2 Injection in Combination With BS006 Injection for the Treatment of Advanced Solid Tumors.","Inclusion Criteria:\n\n* 1\\. Patients with unresectable stage III or IV malignant tumors confirmed by pathology and\u002For 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.\n* 2\\. Lack of standard effective treatment options, or failure of or relapse after standard treatments.\n* 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.\n* 4\\. At least 4 weeks have elapsed since completion of prior antitumor therapies (including endocrine therapy, chemotherapy\u002Fradiotherapy, 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.\n* 5\\. Patients who have undergone major surgery must be at least 4 weeks post-operation.\n* 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.\n* 7\\. No severe dysfunction of major organs.\n* 8\\. Laboratory tests:\n\n  1. White Blood Cell (WBC) ≥3.0×10⁹\u002FL, Absolute Neutrophil Count (ANC) ≥2.0×10⁹\u002FL, Hemoglobin (Hb) ≥90 g\u002FL; Platelet (PLT) ≥100×10⁹\u002FL; absolute lymphocyte count (ALC)≥0.8×10⁹\u002FL;\n  2. Blood urea nitrogen (BUN) and serum creatinine ≤1.5× the upper limit of normal (ULN);\n  3. Total bilirubin (TBIL) ≤1.5× ULN (for patients with hepatic involvement, TBIL ≤3× ULN);\n  4. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5× ULN; for patients with liver metastases, ≤5× ULN;\n  5. Normal coagulation function (Prothrombin Time, APTT, and Thrombin Time ≤1.5× ULN).\n* 9\\. Female subjects and their partners must use effective contraception during treatment and for 3 months after treatment.\n* 10\\. Subjects with genital herpes must have completed herpes resolution for at least 3 months.\n* 11\\. Voluntary signing of the informed consent form, with expected good compliance.\n\nExclusion Criteria:\n\n* 1\\. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.\n* 2\\. Presence of clinically significant cardiovascular or cerebrovascular disease, including:\n\n  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);\n  2. Placement of a cardiac stent within the past 6 months;\n  3. Inadequately controlled hypertension, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n* 3.Uncontrolled primary brain tumors or brain metastases.\n* 4\\. Bone metastases (except for bone metastases that are stable and controlled after treatment), or the presence of active, clinically symptomatic brain metastases.\n* 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.\n* 6\\. History of immunodeficiency (HIV antibody-positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* 7\\. Uncontrolled psychiatric disorders or infectious diseases. Lesions that do not meet the volume requirements for intratumoral injection.\n* 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\u002FmL); 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.\n* 9\\. Positive HIV test result.\n* 10\\. Presence of active tuberculosis infection or other infectious diseases requiring systemic treatment.\n* 11\\. Large amounts of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment.\n* 12\\. Pregnant or breastfeeding women.\n* 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.\n* 14\\. Participation in another clinical study within the past 4 weeks.\n* 15\\. Known allergy to herpes viruses or any components of the study drug.\n* 16\\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.","ALL","18 Years","75 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE1","PHASE2","BS008-001 is a multicenter, open-label phase Ib \u002FII trial in heavily pre-treated patients with advanced solid tumors. Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀\u002FmL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀\u002FmL), 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\u002FiRECIST.",[64],"Solid Tumor","2026-02-01",{"date":67,"type":68},"2026-02-04","ACTUAL",{"date":70,"type":68},"2023-09-07",{"date":72,"type":57},"2028-06-30",{"name":5,"class":6},1]