[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Binhui Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":210},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,66,87,107,125,146,168,188],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Solid Tumor","RECRUITING","2026-02-01",{"date":32,"type":33},"2026-02-04","ACTUAL",{"date":35,"type":33},"2023-09-07",{"date":37,"type":21},"2028-06-30",{"name":39,"class":40},"Binhui Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":20},"100506001","phase-3-oh2-injection-in-melanoma-100506001","NCT05868707","OH2 Injection in Melanoma","To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy","Inclusion Criteria:\n\n1. Over 18 years old, male or female;\n2. Stage III or stage IV melanoma that has been definitively diagnosed by pathology and\u002For cytology and has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations) (progression to unresectable or metastatic melanoma within 6 months after the end of adjuvant therapy or during adjuvant therapy, This adjuvant therapy can be considered as advanced first-line therapy) for patients with unresectable or metastatic melanoma;\n3. The overall percentage of subjects with mucosal melanoma will not exceed 22%;\n4. Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 \\~ 1;\n5. The expected survival time is more than 3 months;\n6. At least 4 weeks after completion of previous antitumor therapy (including chemotherapeutic\u002Fradiotherapy, targeted therapy, immunotherapy) (at least 2 weeks after completion of previous bone radiotherapy, at least 6 weeks after withdrawal of chemotherapy using nitrosourea and mitomycin), and have recovered from adverse reactions of previous treatment (≤ grade 1 or baseline, except hair loss), and 4 weeks after surgery for major surgery;\n7. At least one measurable target lesion was present according to RECIST 1.1 criteria. There are lesions suitable for intratumoral injection. Measurable tumor lesions were defined as longest diameter ≥10 mm and scanning thickness less than 5.0 mm. For lymph node lesions, short diameter ≥15 mm.\n8. Asymptomatic central nervous system metastases, or treated asymptomatic brain metastases, must be examined by computed tomography (CT) or magnetic resonance imaging (MRI) for no disease progression, stable for at least 3 months, and without steroid medication for at least 4 weeks;\n9. No severe dysfunction of major organs; Laboratory tests meet the following criteria:\n\n   1. WBC≥3.0×109 \u002F L, ANC≥2.0×109 \u002F L (no correction by granulocyte colony stimulating factor \\[G-CSF\\] or granulocyte macrophage colony stimulating factor \\[GM-CSF\\] within 14 days prior to screening), PLT≥100×109 \u002FL (do not receive platelet infusion or thrombopoietin \\[TPO\\], thrombopoietin (TPO) receptor agonist or interleukin-11 \\[IL-11\\] within 14 days before screening), Hb≥90 g\u002FL (do not receive blood transfusion or erythropoietin \\[EPO\\] correction within 14 days before screening);\n   2. Blood BUN and blood creatinine within the range of 1.5 times the upper limit of normal value;\n   3. TBIL≤ 1.5 times the upper limit of normal (total bilirubin \\\u003C2×ULN in subjects with Gilbert syndrome, or total bilirubin \\\u003C3×ULN in subjects with indirect bilirubin indicating extrahepatic cause of total bilirubin elevation);\n   4. ALT and AST≤ 2.5 times the upper limit of normal value; Patients with liver metastases do not exceed 5 times the upper limit of normal;\n   5. Normal coagulation function (PT, APPT within 1.5 times the upper limit of normal);\n10. Female subjects of childbearing age must have tested serum-negative for pregnancy before receiving the first trial drug;\n11. Female subjects of reproductive age and male subjects with partners of women of reproductive age received effective forms of contraception during and for 3 months after treatment;\n12. For subjects with genital herpes, need 3 months after the end of herpes;\n13. Voluntary signing of informed consent, expected compliance is good.\n\nExclusion Criteria:\n\n1. Severe medical conditions, including uncontrolled diabetes with medication, severe infections requiring systematic treatment, and active digestive tract ulcers;\n2. Clinically important cardiovascular and cerebrovascular diseases exist, including:\n\n   * Severe or uncontrolled heart disease requiring treatment, congestive heart failure rated III or IV by the New York Cardiology Association, unstable angina that cannot be controlled by medication, myocardial infarction in the last 6 months, ECG QTc interval: Severe arrhythmias requiring medication (other than atrial fibrillation or paroxysmal supraventricular tachycardia) ≥450 milliseconds in men and 470 milliseconds in women;\n   * Patients with heart stents in place within 6 months;\n   * Inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n3. History of primary uveal melanoma or other malignancies within 5 years prior to treatment (except early resection of cervical carcinoma in situ and skin cancer in situ);\n4. A large amount of pleural fluid or ascites with clinical symptoms or symptomatic management;\n5. Bone metastases (stable metastases controlled by treatment can be ruled out) or the presence of active, clinical BMS;\n6. Have an active autoimmune disease that has required systemic treatment within the past 2 years (e.g. with disease-regulating drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency) does not count as systemic therapy;\n7. A history of immunodeficiency (HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n8. Patients with active hepatitis B or hepatitis C: HbsAg or HBCAB-positive patients with HBV DNA copy number positive (limit of quantitative detection is 500IU\u002Fml); HBV DNA (negative for HBV-DNA\u002Fbelow the hospital standard for quantitative testing) must be tested in the screening of such patients; Patients who tested positive for HCV antibodies were enrolled in this study only if HCV RNA test results were negative;\n9. There is an active TB infection or other infectious disease that requires systematic treatment;\n10. The subject has a known history of psychotropic substance abuse, alcoholism, or drug use;\n11. Other investigational agents or antiviral therapies have been or are being used within 4 weeks prior to treatment, except for hepatitis B patients on ongoing treatment who may be treated with Entecavir, Tenofovir dipifuroxide fumarate, or adefovir dipivoxil;\n12. Use of investigational drug within 4 weeks prior to initial dosing;\n13. Had received live attenuated vaccine within 4 weeks prior to initial administration;\n14. Pregnant or lactating women;\n15. The investigator believed that the patient was not eligible to participate in the study for any reason.",{"count":50,"type":21},340,[52],"PHASE3","To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.",[55],"Melanoma",[57],"Oncolytic virus","2025-07-22",{"date":60,"type":33},"2025-07-25",{"date":62,"type":33},"2023-03-08",{"date":64,"type":21},"2027-03",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100457321","phase-1-oh2-oncolytic-viral-therapy-in-central-nervous-system-tumors-100457321","NCT05235074","OH2 Oncolytic Viral Therapy in Central Nervous System Tumors","A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years old, male or female;\n2. Phase I trials select pathologically confirmed recurrent central nervous system tumors (including but not limited to anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma, gliosarcoma, anaplastic ependymoma, Medulloblastoma, malignant meningioma, melanoma, etc.) postoperative patients; Phase IIa trial selects postoperative patients with pathologically confirmed recurrent glioblastoma\n3. KPS score ≥60;\n4. Partial or complete tumor resection, Ommaya reservoir has been placed in the operation area, and drug administration conditions are available;\n5. As assessed by the investigator, the site of injection of the trial drug is expected to be in the supratentorial area;\n6. Life expectancy ≥3 months;\n7. Blood routine: WBC≥ 3.0×10\\^9\u002FL, ANC≥1.5×10\\^9\u002FL, PLT≥100×10\\^9\u002FL, Hb≥9.0 g\u002FdL;\n8. Liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of the normal value; AST and ALT \\\u003C 2.5 times the upper limit of the normal value; serum creatinine ≤1.5 times the upper limit of the normal value, or creatinine clearance ≥50 ml\u002Fmin (calculated by Cockcroft\u002FGault formula);\n9. Coagulation function: INR≤1.5 times the upper limit of the normal value, APTT≤1.5 times the upper limit of the normal value;\n10. Women of childbearing age had a negative pregnancy test result within 14 days before enrollment. Female subjects and their spouses received effective contraceptives during and within 6 months of treatment;\n11. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1.28 days before enrollment, subjects participated in other clinical trial projects.\n\n2.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.\n\n3.The subjects have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.\n\n4.Subjects had received radiotherapy to the brain 3 months before their first use of the test drug.\n\n5.Subjects with other active extracranial malignancies requiring concomitant therapy.\n\n6.Subjects known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.\n\n7.Subjects who are going to undergo or have received tissue\u002Forgan transplantation in the past.\n\n8.The subject has active infection or unexplained fever \\>38.5℃ during the screening period and before the first dose.\n\n9.Subjects with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before screening.\n\n10.Anti-HIV(+) or anti-HCV(+) or specific antibody (TPHA) positive or active hepatitis B (hepatitis B subjects who meet the following criteria are also eligible for inclusion: a) HBV viral load before the first dose The amount must be less than 1000 copies\u002Fml (200 IU\u002Fml), and subjects should receive anti-HBV treatment throughout the trial drug treatment period to avoid viral reactivation; b) For anti-HBc (+), HBsAg (-), anti-HBs ( -) and viral load (-) subjects, do not require prophylactic anti-HBV therapy, but require close monitoring for viral reactivation.\n\n11.Cardiovascular disease meets any of the following: a. Congestive heart failure with cardiac function ≥ NYHA class III; b. Serious arrhythmia requiring drug treatment; c. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass, or stenting occurred within 6 months before the first administration; d. Left ventricular ejection fraction (EF) \\\u003C 60%; e. QTcF interval \\> 450 ms in men, \\> 470 ms in women, or risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome, or family history as judged by the investigator History of arrhythmias (eg, pre-excitation syndrome); f. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).\n\n12.Subjects with active autoimmune disease or a history of autoimmune disease but may relapse, but subjects with the following diseases are not excluded and can be further screened: a. Type 1 diabetes; b. Hypothyroidism (if controllable with hormone replacement therapy alone); c. controlled celiac disease; d. Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, alopecia); e. Any other disease that will not recur in the absence of external triggers.\n\n13.Subjects with unstable mental illness, alcohol, drug or substance abuse. 14. Female subjects who are pregnant or breastfeeding, or who are expected to become pregnant during the trial period (from the screening visit until 180 days after dosing) and male subjects who are expected to conceive their partner.\n\n15\\. The adverse reactions of previous anti-tumor therapy have not recovered to (CTCAE 5.0) grade 1 (except for alopecia).\n\n16\\. The investigator determines that he has a serious uncontrollable disease, or there are other conditions that may affect the acceptance of the treatment in this study, and are considered unsuitable to participate in this researcher.\n\n17\\. Other investigators deem it unsuitable for enrollment.",{"count":74,"type":21},28,[24,25],"In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma.\n\nPhase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.",[78],"Central Nervous System Tumors",[80],"Oncolytic Virus",{"date":60,"type":33},{"date":83,"type":33},"2021-11-16",{"date":85,"type":21},"2026-06-16",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":41},"100409819","phase-1-oh2-injection-in-combination-with-hx008-for-melanoma-100409819","NCT04616443","OH2 Injection in Combination With HX008 for Melanoma.","Phase Ib Study of the Combination Use of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) and HX008 Injection in the Treatment of Melanoma","Inclusion Criteria:\n\n1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology.\n2. Patients who have failed in conventional treatment (including PD-1 monotherapy) (disease progression or intolerance) or who have failed in previously assisted PD-1 monotherapy (last assisted PD-1 treatment relapse or metastasis within 6 months).\n3. Patients with Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1, expected survival time more than 3 months.\n4. Prior anti-tumor treatment (including endocrine, chemical\u002F radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment.\n5. There is at least one measurable lesion that is suitable for intratumoral injection. The measured tumor focus is defined as the longest diameter ≥ 5 mm.\n6. Asymptomatic central nervous system metastasis, or treated asymptomatic brain metastasis patients, must be examined by a computerized fault scan (CT) or MRI for disease-free progression, stable for at least 3 months, and at least 4 weeks without steroid medication.\n7. (a) WBC≥3.0×109／L，ANC≥2.0×109／L ，PLT≥100×109／L，Hb≥90 g\u002FL； (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).\n8. Female subjects and their spouses received effective contraceptives during and within 3 months of treatment.\n9. Subjects with herpes in the reproductive organs needed three months after the end of herpes.\n10. The informed consent was voluntarily signed and the expected compliance was good.\n\nExclusion Criteria:\n\n1. Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.).\n2. Significant surgery is expected to be performed during the 28-day screening period during the study period.\n3. Patients had active infections or unexplained fevers (over 38.5℃)during screening and before the first drug use.\n4. Past or present immunodeficiency diseases.\n5. The lesions do not meet the requirements of injection capacity(1ml) in the tumor body.\n6. Pregnant or lactating women.\n7. Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment.\n8. Allergy to herpes virus and drug ingredients.\n9. History of primary grape-film melanoma or other malignant tumors in the 5 years prior to treatment.\n10. History of tuberculosis, or have tuberculosis at the time of screening.\n11. Suffering from sudden lung disease, intersex lung disease, intersex pneumonia, pulmonary fibrosis, acute lung disease, radioactive pneumonia etc.\n12. Patients with active autoimmune diseases or with a history of autoimmune diseases that may relapse, except for:\n\n    1. Type I diabetes with stable condition after taking a fixed dose of insulin;\n    2. Hypothyroidism;\n    3. Controlled celiac disease;\n    4. Skin diseases that do not require systemic treatment;\n    5. Any other disease that does not re-occur without external triggers.\n13. Concurrent medical condition requiring the use of cortisol (\\>10mg\u002Fday prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment, except for inhalation or topical corticosteroids no more than 10 mg\u002Fday prednisone or equivalent.\n14. The researchers believe that there is any reason why the patient is not suitable to participate in this trial.",{"count":95,"type":21},60,[24,25],"This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with Melanoma.\n\nOH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.",[55],[80],{"date":101,"type":33},"2025-07-24",{"date":103,"type":33},"2020-12-01",{"date":105,"type":21},"2025-11-30",{"name":39,"class":40},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":41},"100392205","phase-1-oh2-injection-in-solid-tumors-100392205","NCT04386967","OH2 Injection in Solid Tumors","Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology and\u002F or cytology; breast cancer, gastrointestinal adenocarcinoma, liver cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase).\n2. The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method.\n3. Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 1, expected survival time more than 3 months.\n4. Prior anti-tumor treatment (including endocrine, chemical\u002F radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment.\n5. Those who have undergone major surgery will have to undergo surgery for four weeks.\n6. There is at least one measurable lesion that is suitable for intratumoral injection. According to RECIST version 1.1, it is determined that at least once the CT or MRI examination shows the tumor lesion, it is possible to measure the tumor focus. The measured tumor focus is defined as the longest diameter ≥ 10 mm and the scanning thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is ≥ 15 mm.\n7. There is no serious dysfunction of the main organs.\n8. (a) WBC≥3.0×109／L，ANC≥2.0×109／L ，PLT≥100×109／L，Hb≥90 g\u002FL； (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).\n9. Female subjects and their spouses received effective contraceptives during and within 3 months of treatment.\n10. Subjects with herpes in the reproductive organs needed three months after the end of herpes.\n11. The informed consent was voluntarily signed and the expected compliance was good.\n\nExclusion Criteria:\n\n1. Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.).\n2. History of primary grape-film melanoma or other malignant tumors in the 3 years prior to treatment. (use of combination drugs only)\n3. Past or present immunodeficiency diseases. (use of combination drugs only)\n4. Treated with PD-1\u002FPD-L1 or PD-L2 monoantigens or inhibitors that have been used or used in the past. (use of combination drugs only)\n5. Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants) during the first 2 years of treatment, such as autoimmune pneumonia, glomerular nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or child asthma. (use of combination drugs only)\n6. Have uncontrolled primary or brain metastatic tumors.\n7. Suffering from uncontrolled mental illness, infectious diseases.\n8. The lesions cannot meet the requirements of injection capacity in the tumor body.\n9. Pregnant or lactating women.\n10. Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment.\n11. Other clinical studies have been taken in the past 4 weeks.\n12. Allergy to herpes virus and drug ingredients.\n13. The researchers believe that there is any reason why the patient is not suitable to participate in this trial.",{"count":20,"type":21},[24,25],"This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma).\n\nOH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.",[28,55],[80],{"date":60,"type":33},{"date":121,"type":33},"2018-11-22",{"date":123,"type":21},"2026-12-13",{"name":39,"class":40},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100512564","phase-1-oh2-administered-by-intratumoral-injection-100512564","NCT05954091","OH2 Administered by Intratumoral Injection","A Phase 1, Open-label Study of OH2, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old\n2. Subject must have histologically- or cytologically-confirmed diagnosis of unresectable locally advanced or metastatic melanoma, pancreatic cancer, liver metastases from colorectal cancer, breast cancer, and other solid tumors. (Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous\u002Fsubcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous\u002Fsubcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer etc. Part 2 Cohort B will include patients who have visceral tumors.)\n3. Subject has measurable disease as determined by RECIST version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.\n4. Subjects who have progressed on or are ineligible for available standard therapy are eligible for this trial after the last dose of the previous treatment which is ≥ 4 weeks or 5 half-lives (if required) before the first dose of study treatment. Note: patients who have previously been treated with IMLYGIC (Talimogene laherparepvec, T-Vec) are eligible after discontinuing the last dose of previous T-Vec treatment for ≥ 12 weeks before first dose of study treatment.\n5. Subject has a predicted life expectancy ≥ 12 weeks.\n6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:\n\n   * Not a woman of childbearing potential (WOCBP) OR\n   * WOCBP who agrees to use an acceptable form of birth control method, including:\n\n   abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), cervical cap, condoms with contraceptive gel\u002Ffoam\u002Fcream, or surgical sterilization (tubal ligation at least 6 months prior to screening or partner who had a vasectomy at least 6 months prior to screening).\n8. Female subject must agree not to breastfeed starting at screening, throughout the study period and 180 days after the final study IP administration.\n9. Female subject must not donate ova starting at screening, throughout the study period and for 180 days after the final study IP administration.\n10. Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.\n11. Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.\n12. Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.\n13. Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.\n14. Subject agrees not to participate in another interventional study while receiving study IP.\n15. Subject has the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant determined by the Investigator.\n2. Subject has had major surgery ≤ 4 weeks of screening.\n3. Subject is concurrently participating in another interventional study or has received an investigational product \\\u003C 4 weeks or 5 half-lives (if required) prior to first IP administration.\n4. Subject with symptomatic central nervous system (CNS) metastases, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT\u002FMRI for ≥ 3 months and have been off steroids for at least 4 weeks prior to first IP administration.\n5. Subject with active autoimmune disease requiring systemic therapy within past 2 years. (e.g., systemic lupus erythematosus, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, hypophysitis, etc.). The following are exceptions to this criterion:\n\n   * Subject with vitiligo or alopecia\n   * Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n   * Childhood asthma that has resolved\n   * Any chronic skin condition that does not require systemic therapy\n   * Type 1 diabetes mellitus ※Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n6. Subject with another malignancy that currently requires treatment.\n7. Subject with tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for AEs or otherwise not considered appropriate for IT injection.\n8. Subject with inadequate organ and marrow functions meeting any of the below criteria:\n\n   * with ongoing continuous supportive treatment\n   * Leukocytes \\\u003C 3000\u002FμL\n   * Absolute neutrophil count \\\u003C 1500\u002FμL\n   * Platelets \\\u003C 100,000\u002FμL\n   * Hemoglobin (Hgb) \\\u003C 9 g\u002FdL\n   * International normalized ratio (INR) \\> 1.5 × ULN and\u002For activated partial thromboplastin time (aPTT) \\> 1.5 × institutional normal limits, except for patients in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal\n   * Total Bilirubin (TBL) \\> 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL \\> 3.0 × institutional normal limits or direct bilirubin \\> 1.5 × institutional normal limits)\n   * Aspartate aminotransferase (AST) and Alanine transaminase (ALT) \\> 3.0 × institutional normal limits. Subjects with tumors in the liver AST and ALT \\> 5 × institutional normal limits.\n   * Albumin \\\u003C 3.0 g\u002FdL\n   * Creatinine \\> 1.5 × institutional normal limits\n9. Subject with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n10. Subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness\u002Fsocial situations that would limit compliance with study visits or requirements, or a condition that could invalidate communication with the Investigator.\n11. Subject is known to be positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody, or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection. HbsAg positive subject should further undergo hepatitis B virus (HBV) DNA titer detection. For HCV antibody positive subject, further HCV RNA testing is required. However, subject with the following conditions can be included in this study: Hepatitis B surface antigen (HBsAg) is negative; if HBcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) \\\u003C 200 IU\u002FmL (or 1000 copies\u002FmL).\n12. Subject has a history of moderate to severe ascites, clinically significant and\u002For rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy, or pericardial and\u002For pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of OH2 is allowed.\n13. Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.\n14. Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris \\\u003C 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia, or congestive heart failure (New York Heart Association grade ≥ 2).\n15. Subject who has a history of bleeding diathesis, are on anti-coagulation therapy, or have abnormal coagulation-fibrinolytic parameters (e.g., activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), and platelet count).\n16. Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia, or hypotension during or following treatment with OH2.\n17. Subject has a known or suspected hypersensitivity to OH2 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).\n18. Subject has had previous exposure with OH2.\n19. Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis).\n20. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.",{"count":133,"type":21},29,[24],"This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced\u002Fmetastatic solid tumors.",[28],"NOT_YET_RECRUITING","2024-12-23",{"date":140,"type":33},"2024-12-27",{"date":142,"type":21},"2025-09-01",{"date":144,"type":21},"2028-01-01",{"name":39,"class":40},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":41},"100492923","phase-1-oh2-oncolytic-viral-therapy-via-transcatheter-intraarterial-infusion-in-patients-with-advanced-liver-cancer-100492923","NCT05698459","OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer","A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure specified in the test);\n2. Age 18-75 years old (inclusive);\n3. Patients with primary or metastatic liver cancer confirmed histologically or cytologically;\n4. Patients with liver cancer who have failed standard treatment, are not suitable for or are not willing to accept standard treatment;\n5. ECOG physical condition 0 or 1;\n6. Meet Child-Pugh liver function rating: Grade A or B;\n7. Adequate bone marrow, liver, kidney and organ functions, meeting the following requirements in laboratory examination within 7 days prior to the first medication (no blood transfusion, blood products, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factors within 14 days prior to the laboratory examination) :\n\n   * Neutrophil absolute count (ANC) ≥1.5×109\u002FL, platelet ≥100×109\u002FL, hemoglobin ≥90g\u002FL;\n   * Serum total bilirubin ≤3 times the upper limit of the normal reference range (3×ULN);\n   * Alanine transaminase (ALT) and\u002For aspartate transaminase (AST) ≤5×ULN;\n   * Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (as calculated by Cockcroft-Gault formula);\n   * International Normalized ratio (INR) ≤1.5 or partially activated prothrombin time (APTT) ≤1.5×ULN;\n8. Subjects with chronic HBV infection must receive HBV-DNA \\\u003C 500IU\u002Fml and HBsAg positive patients must receive antiviral therapy according to the Guidelines for Chronic Hepatitis B Prevention and Treatment 2015 Edition. HCV-RNA positive patients must receive antiviral therapy according to the Hepatitis C Prevention and Treatment Guidelines 2015 Edition and have liver function within the normal range;\n9. Recovery of AE associated with previous systemic chemotherapy, radical\u002Fextensive radiotherapy to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) ≤ Class 1 (except hair loss, non-clinically significant and asymptomatic laboratory abnormalities);\n10. For subjects with herpes, 3 months after completion of herpes treatment;\n11. Expected survival ≥12 weeks;\n12. Fertile women must have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients volunteered to use effective contraceptive methods, such as dual screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices, during the study period and within 90 days of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization (e.g. hysterectomy, bilateral adnexectomy or irradiation of radioactive ovaries).\n13. More than 4 weeks after the end of previous anti-tumor therapy (including endocrine, chemical\u002Fradiotherapy, targeted therapy) (more than 6 weeks after the treatment of nitrosourea and mitomycin chemotherapy);\n14. Four weeks after major surgery;\n15. At least one measurable or evaluable lesion was present according to RECIST1.1 criteria.\n\nExclusion Criteria:\n\n1. A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency within 6 months prior to screening;\n2. Patients with large tumors - tumors \\>50% by liver volume and\u002For invading inferior vena cava;\n3. Non-recovery to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) level 1 toxicity (excluding hair loss, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antitumor therapy prior to initial administration of the study drug;\n4. Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively controlled) in the past 5 years;\n5. For subjects with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging progression is seen at least 4 weeks before the first administration of the trial therapy, and any neurological symptoms have returned to baseline), repeated imaging examinations confirm no evidence of new BMS or the expansion of the original BMS. Participants who do not require steroid therapy at least 14 days before the initial administration of the trial therapy are eligible to participate in the trial. Subjects with cancerous meningitis should be excluded regardless of whether they are clinically stable;\n6. Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, interventional therapy, systemic therapy, radiotherapy and traditional Chinese medicine therapy (the instructions for traditional Chinese medicine therapy with clear anti-tumor indications, and a one-week washout period is enough before the first drug use);\n7. Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks prior to initial medication;\n8. Have previously received similar drugs for antitumor therapy;\n9. Received major surgical operations (the definitions of major surgical operations refer to Grade 3 and Grade 4 operations specified in the \"Measures for the Clinical Application of Medical Technology\" implemented on May 1, 2009) or unhealed wounds, ulcers and fractures within 4 weeks before the first drug use;\n10. The subjects currently have active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases, or active bleeding from unexcised tumors, or other conditions determined by the researchers that may cause digestive tract bleeding and perforation;\n11. Patients with significant evidence or history of bleeding tendency within 2 months prior to initial medication (bleeding \\>30mL within 2 months, hematemesis, black feces, and hematochezia), hemoptysis (\\>5mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and\u002For transient ischemic attacks) within 12 months;\n12. Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to initial medication; New York Heart Association (NYHA) Grade \\>2 for congestive heart failure; Left ventricular ejection fraction (LVEF) \\\u003C50%; Primary cardiomyopathy, a history of clinically significant prolonged QTc interval, or QTc interval \\>470ms in women and \\>450ms in men during the screening period;\n13. Severe and uncorrectable electrolyte abnormalities determined by the investigator to be clinically significant;\n14. The patient had an active infection or developed an unexplained fever (body temperature \\>38.5oC) during screening and prior to initial administration;\n15. Preparing for or having previously received allogeneic organ or bone marrow transplantation, including liver transplantation;\n16. Subjects with a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that might interfere with the detection and management of suspected drug-related pulmonary toxicity;\n17. Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to initial medication; Known human immunodeficiency virus (HIV) infection; The copy number of hepatitis B and hepatitis C virus was active.\n18. Pregnant women (positive pregnancy test before medication) or breastfeeding women;\n19. Known allergy to any herpes virus and OH2 inJ ingredients;\n20. Any other medical condition, clinically significant metabolic abnormality (e.g., uncontrolled diabetes, thyroid dysfunction), physical abnormality, or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition unsuitable for the study drug (e.g., the presence of epileptic seizures and the need for treatment), Or it could affect the interpretation of the findings, or put patients at high risk.\n21. Received the corresponding experimental drugs in clinical trials of other unapproved or unmarketed drugs within 4 weeks before the first drug use;\n22. As determined by the investigator, the subjects had other factors that might have led to the forced termination of the study.",{"count":154,"type":21},12,[24],"An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma",[158],"Advanced Liver Cancer",[80],"2024-12-19",{"date":162,"type":33},"2024-12-20",{"date":164,"type":33},"2023-05-05",{"date":166,"type":21},"2026-01",{"name":39,"class":40},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":41},"100352258","phase-1-oh2-oncolytic-viral-therapy-in-solid-tumors-100352258","NCT03866525","OH2 Oncolytic Viral Therapy in Solid Tumors","Phase I\u002FII Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Malignant Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed unresectable or recurrent\u002Fmetastatic solid tumors.\n2. The patient must have failed the standard treatment (due to either disease progression or intolerable toxicity) or the standard of care had not been established for the specific condition.\n3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n4. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.\n5. Life expectancy \\>3 months.\n6. The patient must have at least one tumor site appropriate for intratumoral injection.\n7. Adequate organ function.\n8. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study.\n9. Participants with a history of HSV infection must have recovered at least 3 months before the study.\n10. Willing and able to provide written informed consent and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Uncontrolled concurrent illness including, but not limited to, severe cardiac disease, cerebralvascular disease, uncontrolled diabetes, uncontrolled hypertension, ongoing or active systemic infection, active peptic ulcer disease.\n2. Central nervous system (CNS) metastases with clinical symptoms\n3. Active infection or an unexplained fever \\> 38.5°C.\n4. Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection.\n5. Pregnant or lactating female.\n6. Patients who are receiving any other investigational agents.\n7. Known immediate or delayed hypersensitivity reaction to HSV.\n8. Previous malignancy within 5 years prior to study entry.\n9. Patients with any active autoimmune disease or history of autoimmune disease.\n10. Concurrent medical condition requiring the use of cortisol (\\>10mg\u002Fday prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment, except for inhalation or topical corticosteroids no more than 10 mg\u002Fday prednisone or equivalent.\n11. Familial, sociological or geographical conditions that, in the judgment of the investigator, do not permit compliance with the protocol.",{"count":176,"type":21},300,[24,25],"This phase I\u002FII study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft tissue sarcomas).\n\nOH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.",[28,180],"Gastrointestinal Cancer",[80],{"date":162,"type":33},{"date":184,"type":33},"2019-04-02",{"date":186,"type":21},"2025-08-30",{"name":39,"class":40},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100457095","phase-1-oh2-oncolytic-viral-therapy-in-non-muscle-invasive-bladder-cancer-100457095","NCT05232136","OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer","Oncolytic Virus (OH2) Adjuvant Therapy After Transurethral Resection of Bladder Tumor in Non-Muscle-Invasive Bladder Cancer Who Have Failed First-line Prophylactic Intravesical Instillation Therapy: a Phase Ⅰb\u002FⅡ Clinical Trial","Inclusion Criteria:\n\n1. Age 18 \\~ 80 years old (including boundary value), male or female.\n2. Failed in first-line preventive bladder perfusion therapy, and retained the bladder (or other reasons are not suitable for radical total cystectomy).\n3. Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer.\n4. Negative histology and pathology of bladder mucosa biopsy and negative postoperative urine cytology during TURBT.\n5. No tumor was found in upper urinary tract examination; No systemic chemotherapy or radiation therapy for bladder cancer has been done at any time before.\n6. ECOG 0-1.\n7. The estimated survival time is more than 1 year.\n8. Laboratory inspection:\n\n   1. WBC≥3.5 × 10\\^9／L，ANC≥1.5 × 10\\^9／L，PLT≥80 × 10\\^9／L，Hb≥90g\u002FL；\n   2. Blood bun and serum creatinine were within 1.5 times of the upper limit of normal value;\n   3. TBIL ≤ 1.5 times the upper limit of normal value;\n   4. ALT and AST ≤ 2.5 times the upper limit of normal value;\n   5. The coagulation function is normal (PT and APTT are within 1.5 times of the upper limit of normal value).\n9. Received effective contraception during and within 3 months after treatment.\n10. At least 3 months after the end of herpes infection.\n11. Voluntary signing of informed consent, expected patient compliance\n\nExclusion Criteria:\n\n1. muscle invasive bladder cancer or bladder cancer with clinical metastasis.\n2. Complications occurred after TURBT, or perfusion therapy could not be performed.\n3. Allergic to GM-CSF products or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug.\n4. Suffering from serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active gastrointestinal ulcer.\n5. Chemotherapy or radiotherapy is expected to be used during the study.\n6. Active infection or fever of unknown cause \\> 38.5 ℃ during screening and before the first administration. Ongoing urinary system infection, especially bladder infection (if the infection can be controlled by antibiotics, except that it can return to normal after 7 days of antibiotic withdrawal).\n7. Congenital or acquired immune deficiency (such as HIV infection) , Hepatitis B infection of HBV-DNA or more than 10 \u002FmL, HCV antibody and HCV RNA positive in hepatitis C infection.\n8. Pregnant or lactating.\n9. Other experimental drugs or antiviral therapy were used or are being used within 4 weeks before treatment.\n10. Participated in immunosuppressive therapy in recent 3 months, including cyclosporine, antithymocyte globulin or tacrolimus.\n11. Participated in cancer vaccine treatment trials in recent 12 months (such as dendritic cell therapy and heat shock vaccine).\n12. History of psychotropic substance abuse, alcoholism or drug abuse.\n13. Other malignant tumors within 5 years before enrollment, except effectively resected cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, skin basal cell carcinoma, skin squamous cell carcinoma, thyroid papillary carcinoma and breast ductal carcinoma in situ.\n14. Active autoimmune diseases or history of autoimmune diseases and may relapse, except:\n\n    1. Type I diabetes mellitus;\n    2. Hypothyroidism (if only controlled by hormone replacement therapy);\n    3. Controlled celiac disease;\n    4. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss);\n    5. Any other disease that will not recur without external triggers.\n15. Using corticosteroids within 14 days before the administration of the study drug due to treatment, or suffering from any disease requiring systemic treatment with other immunosuppressants, except:\n\n    1. Local, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption;\n    2. Prophylactic short-term use of corticosteroids (e.g., allergy to contrast agents) or for the treatment of non autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens).\n16. Not suitable to participate study judged by investigators for any reason.","80 Years",{"count":20,"type":21},[24,25],"This phase Ⅰb\u002FⅡ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy.\n\nOH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.",[200],"Non-muscle-invasive Bladder Cancer",[80],"2024-08-09",{"date":204,"type":33},"2024-08-12",{"date":206,"type":33},"2022-07-11",{"date":208,"type":21},"2025-10",{"name":39,"class":40},""]