[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Abogen Biosciences Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,65,90],{"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},"100522852","phase-1-phase--clinical-study-to-evaluate-abo2011-in-advanced-solid-tumors-100522852",false,"NCT06088004","Phase Ⅰ\u002FⅡ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK\u002FPD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects must be ≥18 years olde.\n2. Ability to sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.\n3. Histopathology or cytology confirmed Advanced solid tumors;\n4. Failed of previous systemic treatment or required treatment histories for selected tumor types;\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Expected survival greater than 12 weeks.\n7. At least one superficial or deep lesion for intratumoral injection and biopsy.\n8. Meet the required level of organ function.\n9. Female patients are postmenopausal or, if women of childbearing potential, have a urine pregnancy or a blood pregnancy that is negative. At the same time, men of childbearing potential and women of childbearing potential voluntarily use effective contraception, including abstinence or effective contraception (e.g., intrauterine or implantable contraceptives, oral contraceptives, injectable or implantable contraceptives, extended-release local contraceptives, intrauterine devices \\[IUDs\\], condoms \\[males\\], diaphragms, cervical caps, etc.) from the time of signing the ICF until 120 days after the end of treatment.\n\nExclusion Criteria:\n\n1. Other malignancies within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, and carcinoma in situ of the cervix.\n2. Central nervous system tumors or metastases with clinical symptoms or asymptomatic brain metastases requiring steroids control.\n3. History of serious cardiac disease, e.g., New York Heart Association (NYHA) ≥ Grade 2 cardiac failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, myocardial infarction within 6 months prior to enrollment, or arrhythmias requiring antiarrhythmic therapy (β-blockers, calcium channel blockers, and digoxin are allowed). QTcF \\> 480 ms.\n4. Poorly controlled clinical complications, including, but not limited to, uncontrolled hypertension with both antihypertensive agents Hypertension and hypoglycemic treatment not Controlled type 2 diabetes, poorly controlled pleural, ascites, or other serious diseases requiring systemic treatment.\n5. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc.; type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy only, and skin diseases that do not require whole body therapy (eg, vitiligo, psoriasis) may be included in the trial.\n6. The subject carried: Known Human Immunodeficiency Virus (HIV); Active hepatitis B virus infection; Active hepatitis C virus infection.\n7. Thrombotic disease or use of full-dose anticoagulant drugs within 6 months prior to screening.\n8. Radiotherapy within 14 days prior to the first dose.\n9. Live or live attenuated vaccines or other vaccines within 30 days prior to the first dose may be determined by the investigator's comprehensive assessment.\n10. Major surgery within 28 days prior to the first dose or non-study-related minor surgery within 14 days prior to the first dose.\n11. Immunosuppressants or other immunomodulatory medications are required within 4 weeks prior to the first dose, but physiologic doses of systemic steroids are allowed or topical. Topical use should not exceed the dose recommended in the package insert or have any signs of systemic exposure; or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation requiring the use of immunosuppressants or other immunomodulatory drugs.\n12. Acute toxic effects of prior anticancer chemotherapy or immunotherapy have not been stable, or significant post-treatment toxicities have been observed.\n13. Any systemic anti-tumor therapy with specific washout windows.\n14. Presence of clinically significant pulmonary fibrosis or interstitial pneumonia.\n15. Presence of active infections, including bacteria, fungi, viruses, and tuberculosis.\n16. Active bleeding, including but not limited to gastrointestinal bleeding, hemoptysis, etc.\n17. History of immediate severe allergic reactions prior to the first dose.\n18. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, which the investigator considers unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},218,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.",[27],"Solid Tumor, Adult","RECRUITING","2026-09-18",{"date":31,"type":32},"2026-09-23","ACTUAL",{"date":34,"type":32},"2023-09-28",{"date":36,"type":20},"2027-12-30",{"name":38,"class":39},"Suzhou Abogen Biosciences Co., Ltd.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100655783","phase-3-phase-iii-clinical-trial-of-lyophilized-herpes-zoster-mrna-vaccine-in-adults-aged-40-years-or-above-100655783","NCT07817108","Phase III Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above","A Phase III Randomized, Double-blind, Placebo-controlled Trial Evaluating the Vaccine Efficacy, Safety, and Immunogenicity of a Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged ≥40 Years","Inclusion Criteria:\n\n1. Be able and willing to comply with the protocol requirements for all scheduled follow up visits, agree to participate in the trial, and voluntarily sign the ICF approved by EC;\n2. Chinese male or female aged ≥40 year. Participants with underlying medical conditions may be enrolled if their conditions are stably controlled;\n3. Be able to communicate well with the investigator, understand and comply with the protocol requirements for trial participation;\n4. Female participants of childbearing potential and male participants (whose female partners are of childbearing potential) must have practiced effective contraception from the end of the last menstrual cycle of the female participant or partner until the day of vaccination, and must continue to use effective contraception for 6 months after completion of the voluntary vaccination. During this period, they must also refrain from donating sperm or ova. Alternatively, female participants may be considered not of childbearing potential.\n\nExclusion Criteria:\n\n1. Within 3 days prior to vaccination, presence of acute illness, acute exacerbation of chronic disease, or febrile\u002Fnear febrile state, or use of anti inflammatory drugs, antibiotics, antihistamines, or antiviral drugs due to physical discomfort;\n2. On the day of vaccination, for participants aged 40-59 years, systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg; for participants aged ≥60 years, systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n3. Female participants who are known to be pregnant or breastfeeding, or who have a positive pregnancy test if of childbearing potential;\n4. History of allergy to any component of the investigational vaccine, or history of severe allergic reactions to other vaccines, foods, or drugs;\n5. History of herpes zoster (shingles), history of varicella (chickenpox) within the past year, or close contact with individuals with varicella\u002Fherpes zoster within the past year;\n6. Previous or planned vaccination with herpes zoster or varicella vaccines (including licensed or unlicensed vaccines) during the trial period;\n7. Use of any vaccine within 30 days prior to vaccination, or planned use of any vaccine other than the investigational vaccine within 30 days after administration of the investigational vaccine;\n8. Current participation in another drug or medical device clinical trial within 6 months prior to vaccination, or planned participation in such a trial before the end of this trial;\n9. History of clinically diagnosed coagulation abnormalities or coagulation disorders, or contraindications to intramuscular injection such as receiving anticoagulant therapy;\n10. Known medical history or diagnosis confirming that the participant has or has had a disease affecting immune system function, including malignancies, congenital or acquired immunodeficiencies, autoimmune diseases, or other conditions affecting immune function;\n11. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;\n12. Uncontrolled cardiovascular diseases, severe or uncontrolled respiratory diseases, neurological diseases, hematological and lymphatic diseases, liver and kidney diseases, metabolic and skeletal system diseases, or known severe congenital malformations, developmental disorders, or clinically diagnosed severe chronic diseases that, in the investigator's judgment, may affect the trial results;\n13. Acute infection, acute phase of chronic infection, or currently receiving anti tuberculosis treatment, or those with a previous positive treponemal antibody test;\n14. History or current presence of clearly diagnosed neurological diseases or psychiatric disorders or family history of neurological\u002Fpsychiatric diseases, receipt of facial fillers within 6 months prior to vaccination, and other neurological diseases that the investigator deems unsuitable for participation;\n15. Current skin diseases that, in the investigator's judgment, may affect trial observations;\n16. Use of long term immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to vaccination, or planned use during the period from enrollment to 1 month after the full course of vaccination, with the exception of topical drugs. Topical drugs should not exceed the recommended dose in the package insert or induce signs of systemic exposure. Long term systemic corticosteroids for ≥14 days at a dose of ≥2 mg\u002Fkg\u002Fday or ≥20 mg\u002Fday prednisone or equivalent;\n17. Receipt of immunoglobulins and\u002For blood products, or blood donation, within 3 months prior to vaccination, or planned during the period from enrollment to 1 month after the full course of vaccination;\n18. Suspected or known drug abuse that, in the investigator's opinion, may affect safety evaluation or trial compliance;\n19. Investigators at the trial site\u002Fstudy site, or employees of the sponsor or third party monitoring company involved in the trial;\n20. Other conditions that the investigator deems unsuitable for participation in this trial.",true,"40 Years",{"count":51,"type":20},18000,[53],"PHASE3","The primary objective of this study is to evaluate the vaccine efficacy, safety and immunogenicity of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.",[56],"Varicella-zoster Virus","2026-09-08",{"date":59,"type":32},"2026-09-14",{"date":61,"type":32},"2026-06-27",{"date":63,"type":20},"2027-10-17",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100639196","early-phase-1-an-exploratory-study-of-personalized-cancer-vaccine-in-adjuvant-therapy-of-solid-tumors-100639196","NCT07583953","An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors","An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors","Inclusion Criteria:\n\n* Key inclusion criteria:\n\n  * ≥18 years of age at time of informed consent\n  * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n  * Life expectancy of ≥6 months\n  * Patient diagnosed with solid tumors and is receiving perioperative and\u002For adjuvant anti-cancer therapy.\n  * Sufficient organ function\n  * Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.\n\nExclusion Criteria:\n\n* Key Exclusion Criteria:\n\n  * For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously\n  * Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer\n  * Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.\n  * Active infections\n  * History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment\n  * Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab\n  * Positive pregnancy test or lactating women",{"count":73,"type":20},50,[75],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.",[78],"Solid Tumors",[80],"The First Affiliated Hospital of Soochow University","NOT_YET_RECRUITING","2026-05-07",{"date":84,"type":32},"2026-05-13",{"date":86,"type":20},"2026-04-17",{"date":88,"type":20},"2031-04-17",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100627975","phase-1-study-of-abo2102-in-kras-mutated-solid-tumors-100627975","NCT07455617","Study of ABO2102 in KRAS-Mutated Solid Tumors","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors","Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations\n3. Histopathologically and\u002For cytologically confirmed locally advanced or metastatic solid tumors.\n4. According to RECIST v1.1, at least one measurable lesion is required.\n5. No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.\n6. Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.\n\nExclusion Criteria:\n\n1. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.\n2. Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .\n3. Received KRAS cancer vaccine before.\n4. History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.\n5. History of allogeneic organ transplantation or graft-versus-host disease (GVHD).\n6. Any active infection (except for hepatitis virus infection) requires systemic treatment.\n7. Absence of spleen\n8. Known psychiatric disorder or drug abuse that may interfere with the trial requirements\n9. Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.\n10. Other conditions that Investigators consider inappropriate for enrollment.",{"count":98,"type":20},101,[23],"This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.",[102],"Advanced \u002F Metastatic Solid Tumor","2026-04-03",{"date":105,"type":32},"2026-04-06",{"date":107,"type":32},"2026-03-24",{"date":109,"type":20},"2030-02",{"name":38,"class":39},1,""]