[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ImmVira Pharma Co. Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100611650","phase-1-a-phase-iiia-study-of-c5252-in-patients-with-intracranial-tumor-100611650",false,"NCT07243340","A Phase I\u002FIIa Study of C5252 in Patients With Intracranial Tumor","A Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed recurrent malignant high-grade (WHO grade 3-4) glioma who have received standard therapy and no available treatment.\n* Measurable lesions exist in accordance with RANO criteria.\n* Sufficient space for ≥1 mL drug infused into tumor cavity post resection.\n* Ommaya reservoir has been placed in the operation area, and drug administration conditions are available.\n* Karnofsky Performance Status (KPS) ≥ 60%\n* Life expectancy \\> 12 weeks.\n* No severe hematological, cardiovascular, liver or kidney diseases.\n* If the patient is a sexually active female of childbearing potential or if the patient is a sexually active male whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of before the C5252 infusion.\n* Capable of understanding and complying with protocol requirements.\n\nKey Exclusion Criteria:\n\n* Inability to undergo MRI examination for any reason.\n* Active hemorrhage observed before enrollment.\n* Imaging test: a. lesion located in non-cerebral regions; b. there are other lesions outside target tumor cavity; c. extra-cranial metastasis.\n* Tumor lesion locates in ventricular system or there is a clear perforation between the tumor cavity and the ventricle after tumor resection.\n* History of encephalitis, multiple sclerosis or other central nervous system infections\n* Treated with steroid hormones and\u002For more than 5 mg dexamethasone per day or other immunosuppressive drugs for systemic treatment within 4 weeks.\n* Persistent or active infection, and cannot be controlled by treatment.\n* Subjects with bleeding tendency or need to take anticoagulant drugs, antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs) and are unable to discontinue.\n* Uncontrolled disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris.\n* Other malignant tumor within 5 years.\n* Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period.\n* In the period of recurrent herpes simplex virus infection, with corresponding clinical manifestations.\n* Systemic use (other than topical) of anti-HSV drugs\n* Prior treatment with any oncolytic virus, cell therapy or gene therapy.\n* Participants have a history of splenectomy, organ transplantation, bone marrow transplantation or stem cell transplantation\n* Prior antitumor treatment with intracranial implants, such as Carmustine.\n* Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the C5252 prescription, including glycerol.\n* Developed ≥Grade 3 irAE during previous immunotherapy\n* History of frequent drug use (including \"recreational use\") or drug abuse (including alcohol abuse) within one year prior to signing the informed consent form.\n* Other situation that PI consider subjects not appropriate to participate in the study.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.",[27],"Glioma, Malignant","NOT_YET_RECRUITING","2025-11-19",{"date":31,"type":32},"2025-11-21","ACTUAL",{"date":34,"type":20},"2025-12-15",{"date":36,"type":20},"2028-12-15",{"name":38,"class":39},"ImmVira Pharma Co. Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100390948","phase-1-a-clinical-study-of-intratumoral-mvr-t3011-t3011-given-as-a-single-agent-and-in-combination-with-intravenous-pembrolizumab-in-participants-with-advanced-or-metastatic-solid-tumors-100390948","NCT04370587","A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors","A Phase 1\u002F2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Disease progression after standard of care (SOC) therapy or in the opinion of\n3. The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.\n\n   Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.\n\n   ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1\u002FPDL1 blockade after receiving at least 2 doses alone or in combination.\n\n   iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.\n\n   iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.\n\n   Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.\n4. Measurable disease per RECIST version 1.1.\n5. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n7. Life expectancy \\> 12 weeks.\n8. Demonstrate adequate organ function as defined by acceptable laboratory testing results.\n9. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.\n10. Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \\> 21 days, or surgical intervention \\> 21 days prior to the first dose of T3011.\n11. Recovered from all prior anticancer therapy toxicities.\n12. Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.\n13. Capable of understanding and complying with protocol requirements.\n14. Signed and dated institutional review board\u002Findependent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.\n\nKey Exclusion Criteria:\n\n1. Have only uninjectable tumors..\n2. Patients with injectable tumors impinging upon major airways or blood vessels.\n3. HNSCC only: Prior re-irradiation field containing carotid artery.\n4. Greater than 3 distant metastatic lymph node regions and\u002For metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)\u002F5 cm (sarcoma) unless the lesion is to be injected.\n5. Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.\n6. Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis\u002Finterstitial lung disease.\n7. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.\n8. Requires continued concurrent therapy with any drug active against HSV.\n9. Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.\n10. Primary or acquired immunodeficient states.\n11. Pregnant or lactating.\n12. Prior organ transplantation.\n13. Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.\n14. Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.\n15. History of or current central nervous system metastases.\n16. History of seizure disorders within 6 months of Screening.\n17. Active oral or skin herpes lesion at Screening.\n18. Active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids.\n19. Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.\n20. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.\n\n18\\. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention.\n\n22\\. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and\u002For interpretation of the current study.",{"count":49,"type":20},30,[23,24],"This is a Phase 1\u002F2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.",[53,54,55,56,57,58],"Solid Tumor","Melanoma","HNSCC","Sarcoma","Squamous Cell Carcinoma","NSCLC","RECRUITING","2025-10-06",{"date":62,"type":32},"2025-10-08",{"date":64,"type":32},"2020-09-17",{"date":66,"type":20},"2027-01-10",{"name":38,"class":39},9,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100590760","phase-2-a-study-of-t3011-in-patients-with-bcg-unresponsive-nmibc-or-bcg-exposed-chemotherapy-unresponsive-nmibc-100590760","NCT06971614","A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC","An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate \u002FHigh-Risk NMIBC","Inclusion Criteria:\n\nParticipants may enter the study only if they meet all the following criteria:\n\n1. Male or female, aged ≥18 years at the time of signing the ICF.\n2. The participants will need to meet the following criteria:\n\n   1. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and\u002For Cis).\n   2. During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy.\n3. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and macroscopic hematuria; participants with Grade \\>1 anti-neoplastic treatment-related toxicities during the screening period may be enrolled after discussion of the investigators and the sponsor.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n5. Expected survival ≥24 weeks.\n6. Laboratory test values meeting the following requirements :\n\n   1. Hematology ANC≥1.5×10\\^9\u002FL. PLT count ≥75×10\\^9\u002FL. Hemoglobin (HGB) ≥90 g\u002FL.\n   2. Renal function Creatinine clearance ≥60 mL\u002Fmin (based on Cockcroft-Gault equation for calculation)\n   3. Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g\u002FL.\n   4. Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN.\n7. For women of childbearing potential (WOCBP), the serum pregnancy test prior to the first dose must be negative and the potential participant must promise to use medically acceptable and effective methods of contraception. after signing the ICF until at least 6 months after the last dose.\n8. Male participants of child-bearing potential must agree to use medically acceptable and effective methods of contraception after signing the ICF until at least 6 months after the last dose; in addition, male potential participants must agree not to donate sperm during this period.\n9. Participants who understand and voluntarily sign the written ICF and are willing and able to comply with all trial requirements.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will not be allowed to participate in this study:\n\n1. Participants meet the following criteria:\n\n   1. Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.\n   2. Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.\n   3. Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic therapies within 4 weeks prior to investigational product.\n   4. Having received radiotherapy within 2 weeks prior to investigational product.\n2. Planning to receive any anti-neoplastic therapy other than the investigational products during this study.\n3. A history of allergic reactions to HSV-1, IL-12, or anti-PD-1 antibodies or biological components similar to them, or known allergic reactions to any component of the T3011 formulation.\n4. A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression.\n5. Concurrent or prior history of other malignancies than that treated in this study.\n6. History or evidence of high-risk cardiovascular diseases, including but not limited to:\n\n   1. Serious cardiac rhythm or conduction abnormalities.\n   2. Acute myocardial infarction, unstable angina, or stroke, etc., developing within 6 months prior to the first dose of the investigational products.\n   3. Coronary angioplasty or stenting within 6 months prior to the first dose of the investigational products.\n   4. New York Heart Association (NYHA) criteria-defined cardiac function \\> Class II; echocardiogram-documented cardiac valve morphological abnormalities (Grade ≥2).\n   5. Left ventricular ejection fraction (LVEF) ˂lower limit of normal (LLN) of the study site, or ˂ 50% if no LLN is set at the site.\n   6. Poorly controlled blood pressure .\n7. The following prior or concurrent immune disorders that in the investigator's opinion would pose unpredictable risks to the participants:\n\n   1. Immune-related pneumonia or other immune-related adverse reactions of Grade ≥3 developing with prior immunotherapy (including but not limited to PD-1\u002FPD-L1).\n   2. Concurrent active immune diseases requiring treatment with systemic immunosuppressants (excluding autoimmune diseases not requiring intervention such as vitiligo and diseases treatable by other alternative drugs such as hypothyroidism that is treated with thyroid hormone replacement therapy originally), or concurrent immune diseases requiring treatment with systemic immunosuppressants that have the potential to recurrence (e.g., systemic lupus erythematosus).\n   3. Other concurrent diseases require treatment with systemic immunosuppressants.\n8. Unexplainable fever \\>38.5℃ during the screening or on the day of treatment (fever judged as tumor-induced by the investigator is eligible for enrollment) that in the investigator's opinion will affect the participation in this trial or interfere with the efficacy assessment.\n9. The following persistent or active infections: human immunodeficiency virus (HIV) antibody-positive, hepatitis B surface antigen \\[HBsAg\\] positive with HBV DNA level ≥2000 IU\u002FmL, hepatitis C virus (HCV) antibody positive with detectable HCV RNA, and other active infections requiring systemic treatment.\n10. Prior history of splenectomy or organ transplantation.\n11. Having previously received treatment with oncolytic virus (e.g., T-VEC, CG0070).\n12. Requiring oral or intravenous use of anti-herpes virus drugs, including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir (except for those to be used locally, such as topically), during the study.\n13. Participants with known psychiatric disorders that may affect compliance in trial or with poor compliance.\n14. Participants with a history of drug abuse (including \"recreational use\") or substance abuse (including alcohol) within one year prior to signing ICF.\n15. Being pregnant or breast feeding, or planning to become pregnant or give birth during this trial.\n16. Having received any live attenuated vaccine within 4 weeks prior to investigational product or planning to receive such vaccines during the study.\n17. Having undergone a major surgery.\n18. Any diseases that at the investigator's discretion may confound the trial results, interfere with the participation in the entire trial, and\u002For would make participating in the trial not in the participant's best interest, or a medical history with treatment or laboratory abnormalities, or any other circumstances that would make it inappropriate for the participant to be enrolled.",{"count":77,"type":20},160,[24],"This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate\u002Fhigh-risk NMIBC.",[81],"Nonmuscle-invasive Bladder Cancer",[81,83,84,85,86],"Herpes Virus T3011 Injection","BCG-Unresponsive","BCG-Exposed","Chemotherapy-Unresponsive","2025-07-17",{"date":89,"type":32},"2025-07-23",{"date":91,"type":32},"2025-06-09",{"date":93,"type":20},"2029-05-31",{"name":38,"class":39},2,""]