[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-solid-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,46,73,94,112,127,148,174,194,224,249,270,291,308,332,354,375,394,412,434,451,480,499,523],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054295","phase-2-yh02-injection-for-intra-tumor-injection-therapy-in-advanced-solid-tumors-with-unresponsive-or-failure-treated-cases-100054295",false,"NCT07697937","YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases","Clinical Study of YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases","YH02","Inclusion Criteria:\n\n* Age: ≥18 years.\n* Resectable malignant solid tumors confirmed by histology or cytology (including head and neck cancer, breast cancer, melanoma, cervical cancer, skin malignancies, salivary gland carcinoma, oropharyngeal carcinoma, etc.) should prioritize treatment options for head and neck cancer, breast cancer, and melanoma.\n* After complete failure of standard treatment (disease progression or intolerance to therapy) and in the absence of effective therapeutic options.\n* There must be at least one measurable lesion (according to the RECIST 1.1 criteria), and the lesion must be suitable for intratumoral injection.\n* ECOG score ≤2.\n* The expected survival period is ≥12 weeks.\n* The subject must demonstrate adequate hematological and organ function, with all laboratory parameters evaluated within 7 days prior to the initial administration and meeting the following criteria: Hematologic system (no recent transfusion or hematopoietic stimulation therapy within 14 days): ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 80 × 10⁹\u002FL; Hemoglobin (Hb) ≥ 85 g\u002FL; Liver function: Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (≤ 3.0 × ULN for patients with Gilbert syndrome or liver metastases\u002Fhepatocellular carcinoma); Alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases or hepatocellular carcinoma: ALT ≤ 5 × ULN; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Albumin ≥ 2.8 g\u002FdL; Renal function: Creatinine ≤ 1.5 × ULN; or Creatinine clearance (Ccr) ≥ 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula, only when creatinine\\> 1.5 × ULN); Coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) or Prothrombin time (PT) ≤ 1.5 × ULN.\n* The subject has voluntarily signed an informed consent form and demonstrates good compliance.\n\nExclusion Criteria:\n\n* Patients had received antitumor therapy for the first time within 4 weeks prior to initial administration, including endocrine therapy, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine-based antitumor treatment; or had participated in other clinical trials within 4 weeks before enrollment.\n\nDevelopment of any other malignant tumor other than the study tumor within 5 years prior to first use of the investigational drug, excluding locally advanced cancers that have been completely cured or are disease-free for at least 5 consecutive years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast ductal carcinoma in situ.\n\n* The adverse effects of previous antitumor treatments have not yet been classified as Grade ≤1 on the NCI CTCAE v5.0 grading scale (excluding toxicities such as alopecia and grade 2 neurotoxicity induced by prior platinum-based therapy, which researchers consider to pose no safety risks).\n* Receiving systemic glucocorticoids (prednisone\\>10 mg\u002Fday or equivalent doses of similar agents) or other immunosuppressive therapies within 2 weeks prior to initial use of the study drug, excluding the following: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoid therapy; short-term (≤1 week) prophylactic use of glucocorticoids (e.g., for contrast agent allergy) or for treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions induced by contact allergens).\n* Immuno-modulatory drugs, including but not limited to thymosin, IL-2, and interferon (IFN), were administered within 2 weeks prior to the first administration of the study drug.\n* A syndrome characterized by clinically significant autoimmune diseases (excluding well-controlled hypothyroidism). Patients with vitiligo, type 1 diabetes mellitus, or psoriasis who do not require systemic treatment and have no history of recurrence in the absence of external triggers are eligible for inclusion.\n* A live attenuated vaccine was administered within 4 weeks prior to the first use of the study drug.\n* Has previously received oncolytic virus therapy or other gene-based therapies.\n* Patients had undergone major surgical procedures or suffered severe trauma within 4 weeks prior to enrollment, or were expected to undergo significant surgery during the study period; furthermore, before the first administration of the investigational drug, all adverse events (AEs) related to surgery or major trauma had not resolved to CTCAE level ≤1 or baseline levels.\n* Patients with clinical manifestations of CNS metastasis or meningeal metastasis, or other evidence indicating that the patient's CNS or meningeal metastatic lesions are not under control, shall be deemed unsuitable for enrollment by the investigator. Patients with clinical symptoms suggestive of brain or meningeal disease require computed tomography (CT) or magnetic resonance imaging (MRI) examination.\n* For patients with previously treated brain metastases, inclusion may be considered if their clinical condition is stable within 4 weeks prior to enrollment, there is no evidence of new lesions or lesion progression, and they have not received glucocorticoid therapy within 1 week before the first administration.\n* Has a medical history of leptomeningitis.\n* Patients with a history or evidence of high-risk cardiovascular disease are eligible, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, grade II-III atrioventricular block), a Fridericia formula-corrected QT interval (QTcF) ≥ 470 msec; acute coronary syndrome (including acute myocardial infarction and unstable angina), stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to first administration; stent implantation within 6 months before initial use of the study drug; congestive heart failure classified as grade ≥ II according to the New York Heart Association (NYHA) criteria; echocardiographic findings of valvular morphological abnormalities (grade ≥ 2); note: patients with grade 1 valvular morphological abnormalities (e.g., mild regurgitation\u002Fstenosis) may be enrolled, but those with moderate valve thickening are excluded; left ventricular ejection fraction (LVEF) \\\u003Cthe institutional lower limit (or LVEF \\\u003C50% if no such limit exists); or poorly controlled blood pressure despite antihypertensive therapy (i.e., systolic blood pressure ≥ 160 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg).\n* Virological tests: Positive for hepatitis B virus surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with hepatitis B virus (HBV) DNA level\\> upper limit of detection (ULN); positive for hepatitis C virus antibody (HCV-Ab) with hepatitis C virus (HCV) RNA level\\> ULN; positive for anti-human immunodeficiency virus antibody (Anti-HIV). Meeting any of the above criteria.\n* Had an active infection requiring systemic treatment (intravenous administration) within 2 weeks prior to the first use of the investigational drug, excluding local treatments.\n\nPatients known to have allergic reactions to any component of the YH02 injection formulation.\n\n* Individuals with known mental disorders that may affect research compliance or substance abuse.\n* Patients who have undergone or plan to undergo organ transplantation (e.g., liver transplantation).\n* Patients who, according to the investigators' assessment, have other severe systemic diseases, abnormal laboratory findings, or other reasons that make them unsuitable for participation in this clinical study.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and genetically modifying the capsid protein, the virus's permeability, tumor targeting capability, and infection efficiency were significantly enhanced. Preclinical pharmacodynamic studies demonstrated that YH02 exhibits potent tumor growth inhibitory effects in various human-and murine-derived solid tumor models (including breast cancer, liver cancer, and melanoma). Given that oncolytic virus therapies already have approved products with demonstrated safety and efficacy worldwide, this study may offer potential clinical benefits for patients with advanced solid tumors who have failed standard treatments.\n\nYH02 injection has undergone an open-label, dose-escalating, and expanded Phase I clinical study in China aimed at evaluating the safety, tolerability, biodistribution characteristics, viral clearance, and immunogenicity of intratumoral administration of YH02 injection in patients with advanced solid tumors who have failed adequate standard therapy and lack effective treatment options, while preliminarily investigating its efficacy. No high-grade adverse drug reactions (ADRs) have been observed to date, nor were there any serious adverse events (SAEs), severe adverse drug reactions (SUSARs), or fatal events. The clinical safety and tolerability of this product for intratumoral administration are favorable.",[27],"Advanced Malignant Solid Tumor",[29,30,31,32],"advanced solid tumors","oncolytic virus","adenovirus","intratumor","RECRUITING","2026-07-07",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2026-06-23",{"date":41,"type":21},"2028-07-31",{"name":43,"class":44},"Tianjin First Central Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100638178","phase-1-phase-iii-study-of-sctb41-plus-sctb39-1with-or-without-standard-therapy-in-advanced-solid-tumours-100638178","NCT07594028","Phase I\u002FII Study of SCTB41 Plus SCTB39-1with or Without Standard Therapy in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39-1With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥ 18 years and ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；\n6. At least one measurable tumor lession according to RECIST v1.1;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Has previously received other immunotherapies other than PD-(L)1 inhibitors；\n3. Other malignancies diagnosed within 5 years prior to the enrollment;\n4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n5. Significant bleeding risk;\n6. Presence of pleural effusion, peritoneal effusion, or ascites;\n7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；\n8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n11. History of organ transplantation or stem cell transplantation;\n12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n13. Pregnant or breastfeeding female.","75 Years",{"count":55,"type":21},126,[57,24],"PHASE1","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[27],[61],"advanced malignant solid tumor","NOT_YET_RECRUITING","2026-05-11",{"date":65,"type":37},"2026-05-18",{"date":67,"type":21},"2026-05-30",{"date":69,"type":21},"2029-05-30",{"name":71,"class":72},"Sinocelltech Ltd.","INDUSTRY",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100618043","phase-1-a-study-of-mhb009c-in-patients-with-advanced-solid-tumors-100618043","NCT07326488","A Study of MHB009C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. At least one measurable lesion per RECIST v1.1 criteria or one bone.\n7. Adequate bone marrow reserve and organ function. -\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.\n4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n5. Severe bone damage caused by bone metastasis of prostate cancer.\n6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.\n7. Severe lung disease affecting pulmonary function.\n8. Vaccinated within 4 weeks before dosing.\n9. Active systemic infection requiring treatment within 7 days before dosing.\n10. Serious cardiovascular or cerebrovascular diseases.\n11. Uncontrolled third-space effusions not suitable for enrollment.\n12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.\n13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n14. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n15. Known alcohol or drug dependence.\n16. Pregnant or breastfeeding women, or individuals planning to conceive. -",{"count":81,"type":21},200,[57,24],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C monotherapy.",[27],"2026-04-08",{"date":87,"type":37},"2026-04-13",{"date":89,"type":37},"2026-03-17",{"date":91,"type":21},"2029-03",{"name":93,"class":72},"Minghui Pharmaceutical (Hangzhou) Ltd",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":45},"100607712","phase-1-a-study-of-mhb048c-in-patients-with-advanced-solid-tumors-100607712","NCT07192120","A Study of MHB048C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors",{"count":81,"type":21},[57,24],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.",[104,27],"mCRPC (Metastatic Castration-resistant Prostate Cancer)",{"date":106,"type":37},"2026-04-09",{"date":108,"type":37},"2026-01-16",{"date":110,"type":21},"2029-10",{"name":93,"class":72},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":45},"100607711","phase-1-a-study-of-mhb042c-in-patients-with-advanced-solid-tumors-100607711","NCT07192107","A Study of MHB042C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors",{"count":81,"type":21},[57,24],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.",[27],{"date":106,"type":37},{"date":124,"type":37},"2025-11-27",{"date":110,"type":21},{"name":93,"class":72},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":45},"100613098","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-biologic-effect-of-vg2062-in-patients-with-solid-tumors-100613098","NCT07262164","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors","An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Signed written informed consent form.\n2. Age 18 to 75 years (inclusive), male or female.\n3. Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.\n4. Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.\n2. Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.\n3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.\n4. Other active uncontrolled infection.\n5. Known alcohol or drug dependence.\n6. Subjects with mental disorders or poor compliance.\n7. Women who are pregnant or breastfeeding.\n8. Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.",{"count":135,"type":21},30,[57],"VG2062 is a Recombinant Human IL12\u002F15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2062, and recommended dose of VG2062 for Phase II trials.",[27],"2026-03-22",{"date":141,"type":37},"2026-03-25",{"date":143,"type":37},"2026-03-18",{"date":145,"type":21},"2028-08",{"name":147,"class":72},"Shanghai Virogin Biotech Co., Ltd.",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":45},"100628306","phase-2-cannabis-extract-in-oncology-patients-for-the-treatment-of-tumor-related-symptom-burden-100628306","NCT07459920","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n1. Written informed consent\n2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over\n3. No previous use of Cannabis in the last 6 months\n4. Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria:\n\n   1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite\n   2. presence of psychological symptoms, such as anxiety, depression and insomnia\n5. ECOG ≤ 3\n6. ESAS-TSDS score ≥ 16\n7. Patients on stable therapy with \"Level II\" or Level III\" opioids according to the WHO analgesic scale and\u002For with adjuvants\n8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:\n\n   1. Negative pregnancy test\n   2. Willingness to use effective contraception (concurrent use of two methods with a Pearl Index \\\u003C 1%) during treatment and for at least 3 months after the last dose of the investigational product.\n9. Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n* 1\\. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity\u002Fallergy to THC or CBD 3. Psychiatric illness related to schizophrenia\u002Fpsychosis 4. Personal history of any type of addiction 5. Pregnancy \u002F breastfeeding 6. PEG feeding 7. Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol 8. Concurrent participation in other clinical studies started less than 30 days ago",{"count":157,"type":21},156,[24],"CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC\u002FCBD extract (Cannabis extract Avextra 10\u002F10 oral solution) on symptom burden in patients with advanced oncological disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.",[27],[162,163,164],"TUmor Related symptom burden","Oncology patients","balanced THC\u002FCBD extract","2026-03-03",{"date":167,"type":37},"2026-03-10",{"date":169,"type":21},"2026-04-01",{"date":171,"type":21},"2028-12-31",{"name":173,"class":44},"National Cancer Institute, Naples",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":45},"100622870","phase-1-a-study-evaluating-the-immunotherapy-treatment-for-ovarian-cancer-and-other-advanced-malignancies-100622870","NCT07389239","A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.","A Phase I\u002FIIA Study Evaluating the Safety and Efficacy of NY-ESO-1TCR\u002FdnTGFBRII Engineered T Cells in Combination With Decitabine in Subjects With Recurrent or Treatment Refractory Ovarian Cancer and Other Advanced Malignancies","Inclusion Criteria:\n\n* Adult subjects (18 years and older) with histologically or cytologically of advanced (metastatic or inoperable) advanced solid tumors.\n* Tumor (either an archival specimen or a fresh biopsy) shows NY-ESO-1 expression of 1+ by IHC (H-score). NY-ESO-1 expression must be confirmed by central validated assay.\n* Patients with NY-ESO-1 expressing solid tumors will be included. Patients must have received, been intolerant of, or been ineligible to receive at least 2 lines of the current standard of care therapy including but not limited to chemotherapy, immunotherapy and\u002For targeted therapy when appropriate (e.g. Atezolizumab is approved for use in patients with alveolar soft part sarcoma) according to their disease:\n* Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma:\n* Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy\n* If platinum sensitive disease, should have received ≥2 lines of chemotherapy.\n* May have received PARP inhibitors, bevacizumab or other targeted VEGF inhibitor therapy\n* Inoperable or metastatic (advanced) soft tissue sarcoma:\n* Subjects must have previously received either an anthracycline or ifosfamide containing regimen.\n* Gastrointestinal stromal tumors are eligible, but only must have previously received KIT-targeted therapy if a sensitizing mutation is present.\n* Angiosarcomas are eligible, but only must have received prior taxane-based chemotherapy\n* Urothelial carcinoma:\n* Subjects must have received or refused 1 prior platinum-based therapy for the treatment of metastatic or locally advanced unresectable disease.\n* Subjects who are not eligible for a platinum-containing regimen or who have progressed on a platinum-containing regimen\n* Subjects may have received an anti-PD-l\u002FPDL1 checkpoint inhibitor\n* Metastatic castration-resistant adenocarcinoma of the prostate (CRPC) defined as serum testosterone level ≤ 50 ng\u002FdL with prior surgical castration or ongoing androgen deprivation, with progressive disease:\n* Progressive disease is defined by rising prostate specific antigen (PSA) or radiographic imaging according to the PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration\n* At least one prior chemotherapy regimen in the metastatic setting\n* Prior therapy with at least one standard 17α lyase inhibitor or second generation anti-androgen therapy for the treatment of castrate- resistant prostate cancer.\n* Breast Cancer\n* Prior standard of care regimens with at least one anthracycline or taxane-based regimen in either an adjuvant or metastatic setting unless intolerant or clinically not indicated. For ER positive HER2 negative cancer must have progressed on therapy with CDK 4\u002F6 inhibitor combination. Prior hormonal therapy or Human epidermal growth factor receptor-2 (HER2) targeted therapies are allowed.\n* Melanoma\n* A PD-1 or PD-L1 inhibitor (with or without a cytotoxic T lymphocyte-associated protein 4 \\[CTLA-4\\] inhibitor). Patients with an actionable mutation (e.g., BRAF) must have received at least one targeted therapy.\n* Non-small cell lung cancer\n* A PD-1 or PD-L1 inhibitor and for patients with a PD-L1 tumor proportion score (TPS) \\\u003C 50%, a platinum-based chemotherapy regimen. Patients with non-squamous NSCLC with an actionable mutation (e.g., EGFR, ALK, ROS-1) must have received at least one targeted therapy. A checkpoint inhibitor is not required for patients with actionable mutations.\n* Additional advanced solid tumor expressing NY-ESO-1 are included. Patients must have received a minimum of one prior therapy.\n* Subjects who are intolerant to required prior therapies must have previously received at least one systemic therapy that was deemed ineffective by the treating physician.\n* At screening, must have tissue available for NY-ESO-1 testing (if not previously performed) or be willing and able to undergo a fresh tissue biopsy.\n* HLA-A\\*0201 (HLA-A2.1) positivity by molecular subtyping (blood test or buccal swab, historical documentation acceptable).\n* Age ≥ 18 years old.\n* Life expectancy greater than 3 months assessed by a study physician.\n* Have been informed of other treatment options.\n* A minimum of one measurable lesion defined as meeting the criteria for measurable disease according RECIST1.1 criteria.\n* No restriction based on prior treatments provided they have discontinued therapy at least 4 weeks prior to starting study treatment. Lesions amenable to radiotherapy or palliative radiotherapy (e.g.- bone metastases or metastases causing nerve impingement) should be treated \\> 4 weeks prior to enrollment and patients must be fully recovered from the effects of radiation prior to receiving the investigational agent and that patients must not receive radiation while enrolled on this study.\n* Patients must have received prior anti-cancer treatment(s) or an investigational product(s) within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment(s) AND unresolved or unstable serious toxic side-effects of prior chemotherapy\u002Ftreatment must have recovered to Grade 1 per CTCAE (v5.0)\n* Must have adequate venous access for apheresis and must be willing to and able to go through the procedure.\n* Women of childbearing potential must agree to use effective methods of birth control for the duration of the study and 6 to 12 months after until persistence of the study drug is no longer detected in the peripheral blood. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception. It is recommended that a combination of two methods be used.\n* ECOG performance status ≤1 (Karnofsky ≥80%, see Appendix A).\n* Patients must have normal organ and marrow function as defined below:\n* leukocytes ≥3,000\u002FmcL\n* absolute neutrophil count ≥1,000\u002FmcL\n* platelets ≥100,000\u002FmcL\n* total bilirubin ≤1.5 × ULN (institutional upper limit of normal)\n* AST(SGOT)\u002FALT(SGPT) ≤2.5 × ULN (institutional upper limit of normal)\n* creatinine ≤2 × ULN (institutional upper limit of normal) OR\n* creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels \\> 2 × ULN\n* Patient must understand the investigational nature of this study and be willing to sign a written informed consent form prior to receiving any study related procedure.\n* Participant must agree to and arrange for a caregiver (age ≥ 18 years old) available 24 hours a day\u002F 7 days a week and arrange for lodging within 45 minutes-drive to UChicago and transportation for a period of time after discharge from the hospital. The exact amount of time will depend on the individual status as determined by the treating physician.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure with New York Heart Association class III or IV disease, patients with a LVEF \\\u003C 45%, a myocardial infarction within 6 months prior to study entry or a history of myocarditis, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with active autoimmune disease requiring doses of corticosteroids of ≥ 10 mg\u002Fday of prednisone (or its equivalent) or other immunosuppressive treatments.\n* History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.\n* Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (inhaled or topical steroids at standard doses or isolated use of steroids as premedication for medical procedures to minimize allergic reaction \\[e.g. CT scan dye\\] are allowed).\n\nKnown cases of clinically active brain metastases (brain MRI as clinically indicated) because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment.\n\n* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.\n* Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal for two years,or must agree to use effective contraception during the period of treatment and after as stated in inclusion 3.1.9. Patients with reproductive potential must have a negative pregnancy test (serum\u002Furine) within 48 hours from starting the conditioning chemotherapy.\n* Lack of availability of a patient for immunological and clinical follow-up assessment.\n* Patients with pulmonary function test abnormalities as evidenced by a FEV1\u002FFVC\\\u003C70% of predicted for normality will be excluded.\n* Patients with baseline O2 saturation \\\u003C90% on room air.\n* Patients with history of pneumonitis and\u002For interstitial lung disease.\n* Patients with ascites, pleural or pericardial effusions which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months.\n* Patients that have had \"any major surgical procedure (planned or anticipated) within 4 weeks from the first dose of study treatment(s).\n* Patients who have received any live vaccines within 30 days prior to enrollment.",{"count":5,"type":21},[57,24],"This phase I\u002FIIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.",[185,27],"Ovarian Cancer","2026-02-17",{"date":188,"type":37},"2026-02-20",{"date":39,"type":21},{"date":191,"type":21},"2031-12-10",{"name":193,"class":44},"University of Chicago",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100618892","phase-1-a-first-in-human-study-of-plt012-in-participants-with-solid-tumor-cancers-100618892","NCT07337525","A First in Human Study of PLT012 in Participants With Solid Tumor Cancers","A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Aged at least 18 years and provided written informed consent\n* Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)\n* Has at least one measurable lesion per RECIST v1.1\n* ECOG PS of 0 to 1\n* Life expectancy of ≥ 12 weeks\n* Child-Pugh score of Class A (for hepatocellular carcinoma only)\n* Adequate organ function as defined by protocol-specified laboratory values\n* Not pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Insufficient washout period from prior therapies as defined in the study protocol\n* Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)\n* Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)\n* Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections\n* Unstable\u002Funcontrolled or untreated central nervous system (CNS) metastasis\n* Active or recent (within 3 years) autoimmune disease requiring medical treatment\n* Recipient of any organ transplant including allogeneic stem-cell transplant\n* Clinically significant and active cardiovascular disease\n* Known active alcohol or drug abuse\n* Psychiatric disorders that would prohibit the understanding of the Informed Consent Form\n* Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)",{"count":202,"type":21},36,[57],"The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are:\n\nWhat adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and\u002For preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug).\n\nParticipants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment.\n\nFor the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.",[27,206],"Solid Tumor Cancer",[208,209,210,211,212,213,214],"Gastrointestinal cancer","Liver metastases","Bladder cancer","Liver cancer","Phase 1","Dose escalation","Advanced solid tumors","2026-02-13",{"date":217,"type":37},"2026-02-18",{"date":215,"type":37},{"date":220,"type":21},"2028-01",{"name":222,"class":72},"Pilatus Biosciences Inc",2,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":45},"100615526","phase-1-an-early-phase-trial-of-rptr-1-201-in-advanced-solid-tumors-100615526","NCT07293754","An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors","A Phase 1\u002F2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors","RaPTR-101","Inclusion Criteria\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.\n* At least one measurable lesion per RECIST v1.1 as assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function as defined in the trial protocol.\n* Ability to provide written informed consent and comply with trial procedures.\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.\n* Known active leptomeningeal disease or uncontrolled central nervous system metastases.\n* Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.\n* Prior allogenic organ transplantation\n* Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.\n* Other protocol-defined inclusion and exclusion criteria apply",{"count":233,"type":21},150,[57,24],"This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.",[27],[238,239,240],"advanced cancer","solid tumors","immunotherapy","2026-02-12",{"date":186,"type":37},{"date":244,"type":37},"2025-12-12",{"date":246,"type":21},"2029-04-15",{"name":248,"class":72},"Repertoire Immune Medicines",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":45},"100623054","phase-1-a-study-of-jskn027-in-patients-with-advanced-solid-tumors-100623054","NCT07391644","A Study of JSKN027 in Patients With Advanced Solid Tumors","A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing the ICF.\n* ECOG performance status 0-1.\n* Estimated life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.\n* For dose escalation (Part Ia): disease has progressed on standard therapy.\n* For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.\n* At least one measurable extracranial lesion per RECIST v1.1.\n* Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100×10\\^9\u002FL).\n* Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST\u002FALT, ALP within protocol-defined limits; albumin ≥ 30 g\u002FL).\n* Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin; urine protein within acceptable limits).\n* Adequate coagulation function within 7 days prior to enrollment (e.g., PT\u002FINR and aPTT within protocol-defined limits).\n* Adequate cardiac function (e.g., LVEF ≥ 50%).\n* Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).\n* Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.\n* Major surgery within 28 days prior to first dose or planned major surgery during the study.\n* History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.\n* Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.\n* Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD\u002Fpneumonitis at screening.\n* Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).\n* Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency\u002Finfection not adequately controlled per local standards.\n* Prior allogeneic organ or bone marrow transplant.\n* Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would compromise participant safety or compliance.",{"count":257,"type":21},250,[57],"This is a first-in-human, open-label, multicenter Phase 1 (Ia\u002FIb) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D).\n\nThe study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.",[27],"2026-01-30",{"date":263,"type":37},"2026-02-06",{"date":265,"type":21},"2026-03-15",{"date":267,"type":21},"2029-06-30",{"name":269,"class":72},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100602966","phase-2-a-study-of-mhb036c-combined-with-mhb039a-in-patients-with-advanced-breast-cancer-or-other-advanced-malignant-solid-tumors-100602966","NCT07130383","A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 and ≤75 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors.\n6. At least one measurable lesion per RECIST v1.1 criteria.\n7. Adequate bone marrow reserve and organ function.\n8. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.\n\n   \\-\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n4. Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.\n5. Vaccinated with attenuated live vaccines within 4 weeks before dosing.\n6. Treated with with systemic corticosteroids within 14 days before dosing.\n7. Central nervous system metastasis.\n8. Uncontrolled third-space effusion.\n9. Serious cardiovascular or cerebrovascular diseases.\n10. Severe lung disease affecting pulmonary function.\n11. Active infection requiring systemic therapy.\n12. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n13. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n14. Known alcohol or drug dependence.\n15. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":278,"type":21},210,[24],"This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.",[282,27],"Advanced Breast Cancer","2025-11-16",{"date":285,"type":37},"2025-11-18",{"date":287,"type":37},"2025-09-30",{"date":289,"type":21},"2031-08",{"name":93,"class":72},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":45},"100602680","phase-1-a-study-of-mhb088c-combined-with-mhb039a-in-patients-with-advanced-malignant-solid-tumors-100602680","NCT07126665","A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors","An Open-label Phase I\u002FII Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and\u002For radical concurrent\u002Fsequential radiotherapy and chemotherapy.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate bone marrow reserve and organ function.\n9. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before dosing.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n4. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n5. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.\n6. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.\n7. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.\n8. Vaccinated within 4 weeks before dosing.\n9. Treated with systemic corticosteroids within 14 days before dosing.\n10. Severe lung disease affecting pulmonary function.\n11. Active systemic infection requiring treatment within 7 days before dosing.\n12. Uncontrolled third-space effusion.\n13. Serious cardiovascular or cerebrovascular diseases.\n14. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n15. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n16. Known alcohol or drug dependence.\n17. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":299,"type":21},116,[57,24],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.",[27],{"date":285,"type":37},{"date":305,"type":37},"2025-09-18",{"date":289,"type":21},{"name":93,"class":72},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100601428","phase-1-a-clinical-study-of-bt02-in-treating-patients-with-advanced-lung-cancer-100601428","NCT07110363","A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer","An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. Patients with pathologically confirmed locally advanced\u002Funresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced\u002Funresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .\n2. Adequate organ and hematologic function.\n3. At least 1 extracranial measurable lesion.\n4. An ECOG activity status score of 0-1.\n5. A life expectancy of ≥ 3 months.\n6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.\n7. Good compliance and willingness to follow up.\n\nExclusion Criteria:\n\n1. Patients with sensitive mutations or gene fusions related to lung cancer.\n2. Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.\n3. A history of active autoimmune disease within the past 2 years.\n4. A history of clinically significant cardiovascular disease, severe cardiac rhythm \u002Fconduction abnormalities or LVEF \\\u003C50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.\n5. A severe acute or chronic infection when enrollment.\n6. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .\n7. Unresolved \\> Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.\n8. Clinically active CNS metastases or meningeal metastases.\n9. A history of other type of malignancies.\n10. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.\n11. Poor compliance.\n12. A history of alcohol or drugs abuse.\n13. Current pregnancy or breastfeeding.\n14. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.",{"count":316,"type":21},58,[57],"The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.",[27,320,321,322],"Advanced Lung Cancer","Non-Small Cell Lung Cancer","Small Cell Lung Cancer","2025-08-05",{"date":325,"type":37},"2025-08-07",{"date":327,"type":21},"2025-08",{"date":329,"type":21},"2027-05",{"name":331,"class":72},"Biotroy Therapeutics",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":45},"100598881","phase-1-phase-iii-study-of-sctb39g-in-advanced-solid-tumours-100598881","NCT07077252","Phase I\u002FII Study of SCTB39G in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39G in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n* 1.Voluntarily sign the informed consent form (ICF);\n* 2.Male or female, ≥ 18 years and ≤ 70 years old;\n* 3.Survival duration more than 3 months;\n* 4.ECOG score ≤ 1 point;\n* 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；\n* 6.At least one measurable tumor lession according to RECIST v1.1;\n* 7.Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* 1.Has participated in another clinical study within 4 weeks prior to the first dose;\n* 2.Other malignancies diagnosed within 1 years prior to the enrollment;\n* 3\\. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n* 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation;\n* 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding;\n* 6.Presence of pleural effusion, peritoneal effusion, or ascites;\n* 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment\n* 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n* 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n* 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n* 11.History of organ transplantation or stem cell transplantation;\n* 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n* 13.Pregnant or breastfeeding female.","70 Years",{"count":135,"type":21},[57,24],"This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[27],[345],"Phase I\u002F II Study of SCTB39G in Advanced Solid Tumours","2025-07-11",{"date":348,"type":37},"2025-07-22",{"date":350,"type":21},"2025-07-28",{"date":352,"type":21},"2027-10-17",{"name":71,"class":72},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":45},"100596835","phase-1-phase-iii-study-of-sctb39-1-in-advanced-solid-tumours-100596835","NCT07050641","Phase I\u002FII Study of SCTB39-1 in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, over 18 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. At least one measurable tumor lession according to RECIST v1.1;\n8. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Other malignancies diagnosed within 5 years prior to the enrollment;\n3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n4. Significant bleeding risk;\n5. Presence of pleural effusion, peritoneal effusion, or ascites;\n6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n9. History of organ transplantation or stem cell transplantation;\n10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;\n12. Pregnant or breastfeeding female.",{"count":362,"type":21},110,[57,24],"This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[27],[61],"2025-07-02",{"date":369,"type":37},"2025-07-04",{"date":371,"type":37},"2025-06-23",{"date":373,"type":21},"2028-06-30",{"name":71,"class":72},{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":45},"100596438","phase-1-a-study-of-mhb118c-injection-in-patients-with-advanced-solid-tumors-100596438","NCT07045454","A Study of MHB118C Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Able to understand and comply with the study protocol and follow-up procedures.\n6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n4. Severe lung disease affecting pulmonary function.\n5. Active systemic infection requiring treatment within 7 days before dosing.\n6. Serious cardiovascular or cerebrovascular diseases\n7. Uncontrolled third-space effusions not suitable for enrollment.\n8. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n9. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n10. Known alcohol or drug dependence.\n11. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":81,"type":21},[57],"This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C monotherapy.",[27],"2025-06-22",{"date":388,"type":37},"2025-07-01",{"date":390,"type":37},"2025-03-31",{"date":392,"type":21},"2031-03",{"name":93,"class":72},{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":45},"100475970","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-biologic-effect-of-vg2025-in-patients-with-solid-tumors-100475970","NCT05477849","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors","A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors",{"count":135,"type":21},[57],"VG2025 is a Recombinant Human IL12\u002F15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.",[27],"2025-03-26",{"date":406,"type":37},"2025-04-01",{"date":408,"type":37},"2022-08-23",{"date":410,"type":21},"2025-12-31",{"name":147,"class":72},{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":45},"100571337","early-phase-1-study-on-the-safety-and-efficacy-of-intravenous-administration-of-idov-safetm-in-the-treatment-of-advanced-solid-tumors-100571337","NCT06718946","Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors","A Phase I Clinical Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age: from 18 to 75 years old.\n2. At the time of screening, the patient had at least one measurable target lesion.\n3. Patients with advanced solid tumors who have failed standard therapy during screening.\n4. When screening, the ECOG score of physical strength score is 0 or 1.\n5. Life expectancy assessed by the investigator at the time of screening was ≥3 months.\n6. Subject has qualified organ function at baseline:\n\n   a) Bone marrow function (no growth factor support therapy or component transfusion within 14 days prior to screening) : i. Neutrophil absolute value (ANC) ≥1.5×10\\^9\u002FL; ii. Hemoglobin (HB) ≥90g\u002FL; iii. Platelet count (PLT) ≥75×10\\^9\u002FL; b) Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5 times ULN (ALT and AST≤5 times ULN, TBIL≤3 times ULN for liver metastasis or hepatocellular carcinoma); c) Renal function: serum creatinine ≤ULN or creatinine clearance ≥80mL\u002Fmin;\n7. Fertile female subjects must have negative blood beta-HCG test results within 7 days prior to enrollment.\n8. Subjects must agree to use highly effective contraception for at least 90 days from the start of the ICF to the end of the study.\n9. Be fully informed of this study and voluntarily sign ICF.\n\nExclusion Criteria:\n\n1. Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.\n2. Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n3. At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone \\>10mg\u002F day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.\n4. Patients with received allogeneic tissue or solid organ transplantation.\n5. There is evidence of clinically significant immunodeficiency, such as primary immunodeficiency status, such as severe combined immunodeficiency disease (SCID); Combined with opportunistic infections.\n6. Anticoagulants or antiplatelet drugs should be used before injection and should not be interrupted, including: aspirin should not be stopped within 7 days before injection; Coumarin that cannot be stopped within 7 days prior to injection; Direct thrombin inhibitors (such as dabigatrun) or direct factor Xa inhibitors (such as rivaroxaban, apixaban, and neperoxaban) that cannot be discontinued within 4 days prior to injection; Low molecular weight heparin (LMWH) should not be stopped within 24 hours before injection, and ordinary heparin (UFH) should not be stopped more than 4 hours before injection.\n7. Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: congestive heart failure ≥II heart function grade of the New York Heart Association (NYHA); Left ventricular ejection fraction (LVEF) \\\u003C50%; QT interval (QTcF) \\>470ms as corrected by the Fridericia method or prolonged QT interval syndrome; Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before first administration; The presence of uncontrolled hypertension (systolic blood pressure \\>140mmHg or diastolic blood pressure \\>90mmHg). Subjects with a history of hypertension are admitted to the study if their blood pressure is controlled and maintained below this standard with antihypertensive therapy.\n8. Patients with received treatment with other methods, including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first use of the investigational drug.\n9. Other diseases or abnormalities assessed by the investigator as unsuitable for participation in the study.\n10. Vaccination against smallpox or monkeypox within 10 years.",{"count":420,"type":21},38,[422],"EARLY_PHASE1","This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of Intravenous Administration of IDOV-SAFETM in patients with advanced solid tumors.",[27],"2025-02-04",{"date":427,"type":37},"2025-02-06",{"date":429,"type":37},"2024-12-10",{"date":431,"type":21},"2027-12-31",{"name":433,"class":44},"Fudan University",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":450,"locationsCount":4},"100570892","early-phase-1-study-on-the-safety-and-efficacy-of-intratumoral-administration-of-idov-safetm-in-the-treatment-of-advanced-solid-tumors-100570892","NCT06713148","Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors","A Phase I Clinical Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. 18 \\~75 years old, gender is not limited;\n2. During screening, patients with advanced malignant solid tumors confirmed by histology or cytology (mainly including breast cancer (triple-negative priority), melanoma, head and neck tumors, and gastrointestinal cancers such as colorectal cancer, cholangiocarcinoma, pancreatic cancer, and liver cancer with intratumoral injection conditions).\n3. At the time of screening, the disease has progressed after or during standard treatment; Or subjects with advanced malignant solid tumors who currently have no standard treatment available or are intolerant to chemotherapy.\n4. Tumor lesions and\u002For metastases with at least one evaluable lesion that is subcutaneously accessible or can be injected under imaging guidance, according to the solid tumor response criteria (RECIST version 1.1).\n5. When screening, the ECOG score of physical strength score is 0 or 1.\n6. Life expectancy assessed by the investigator at the time of screening was ≥3 months.\n7. Subjects had adequate organ function at baseline:\n\n   a) Bone marrow function (no growth factor support therapy or component transfusion within 14 days prior to screening) : i. Neutrophil absolute value (ANC) ≥1.5×10\\^9\u002FL; ii. Hemoglobin (HB) ≥90g\u002FL; iii. Platelet count (PLT) ≥75×10\\^9\u002FL; b) Liver function: i. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN) (ALT and AST≤ 3 times ULN for liver metastasis or hepatocellular carcinoma); ii. Blood total bilirubin ≤1.5 ULN (in subjects with liver metastasis or hepatocellular carcinoma or Gilbert syndrome or familial benign nonbinding hyperbilirubinemia, the acceptable range of this indicator is ≤2.5 ULN); c) Renal function: serum creatinine ≤ 1.5x ULN or creatinine clearance ≥50mL\u002Fmin; d) left ventricular ejection fraction (LVEF) ≥ 45%. e) Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN, International Standardized ratio (INR) ≤1.5×ULN.\n8. Fertile female subjects must have negative blood beta-HCG test results within 7 days prior to enrollment.\n9. Subjects must agree to use highly effective contraception for at least 90 days from the start of the ICF to the end of the study.\n10. Be fully informed of this study and voluntarily sign ICF.\n\nExclusion Criteria:\n\n1. At the time of screening, advanced malignant tumors have a chance of being cured by radical treatment.\n2. Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.\n3. Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n4. At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone \\>10mg\u002F day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.\n5. Patients with received allogeneic tissue or solid organ transplantation.\n6. There is evidence of clinically significant immunodeficiency, such as primary immunodeficiency status, such as severe combined immunodeficiency disease (SCID); Combined with opportunistic infections.\n7. Anticoagulants or antiplatelet drugs should be used before injection and should not be interrupted, including: aspirin should not be stopped within 7 days before injection; Coumarin that cannot be stopped within 7 days prior to injection; Direct thrombin inhibitors (such as dabigatrun) or direct factor Xa inhibitors (such as rivaroxaban, apixaban, and neperoxaban) that cannot be discontinued within 4 days prior to injection; Low molecular weight heparin (LMWH) should not be stopped within 24 hours before injection, and ordinary heparin (UFH) should not be stopped more than 4 hours before injection.\n8. Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: congestive heart failure ≥II heart function grade of the New York Heart Association (NYHA); Left ventricular ejection fraction (LVEF) \\\u003C50%; QT interval (QTcF) \\>470ms as corrected by the Fridericia method or prolonged QT interval syndrome; Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before first administration; The presence of uncontrolled hypertension (systolic blood pressure \\>140mmHg or diastolic blood pressure \\>90mmHg). Subjects with a history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.\n9. Patients with received treatment with other methods, including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first use of the investigational drug.\n10. Other diseases or abnormalities assessed by the investigator as unsuitable for participation in the study.\n11. Vaccination against smallpox or monkeypox within 10 years.",{"count":442,"type":21},42,[422],"This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM in patients with advanced solid tumors.",[27],{"date":427,"type":37},{"date":448,"type":21},"2025-04-10",{"date":431,"type":21},{"name":433,"class":44},{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":468,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":45},"100571923","phase-1-a-study-of-mt027-in-patients-with-pleural-malignant-tumors-100571923","NCT06726564","A Study of MT027 in Patients with Pleural Malignant Tumors","A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors","Inclusion Criteria:\n\n1. voluntarily participate in the study and sign informed consent;\n2. age over 18 years old (including the cut-off value), regardless of gender;\n3. advanced malignant solid tumor pathologically and\u002For histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);\n4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;\n5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;\n6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and\u002For pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression;\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;\n8. within 7 days before treatment laboratory meet the following criteria:\n\nRoutine blood (14 days) :\n\n1. Absolute neutrophil count (ANC) ≥1.5×109 \u002FL;\n2. platelet count (PLT) or 80 x 109 \u002F L;\n3. hemoglobin (HGB) or 80 g\u002FL (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ;\n\nLiver:\n\n1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);\n2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;\n\nKidney:\n\n1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (estimated by Cockcroft-Gault formula);\n\n   Blood coagulation function:\n2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less;\n3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause.\n\nExclusion Criteria:\n\n1. known allergy to the study drug or its excipients;\n2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;\n3. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);\n4. in the first test within 2 weeks before treatment received radiotherapy.\n5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;\n6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.\n7. participated in other drug clinical trials within 4 weeks before screening;\n8. always had targeted B7 - H3 CAR - T cells treatment;\n9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases;\n10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs;\n11. patients with severe autoimmune diseases;\n12. recipients of previous allogeneic tissue\u002Fsolid organ transplantation;\n13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;\n14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody;\n15. subjects had severe neurocognitive impairment as judged by the investigator;\n16. pregnant or lactating women;\n17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.",{"count":459,"type":21},18,[57],"This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK\u002FPD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..\n\nSubjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.",[27,463,464,465,466,467],"Malignant Pleural Effusion","Pleura Carcinoma","Pleural Mesothelioma","Pleural Malignant Mesothelioma","Pleural Metastases",[469,470,471],"advanced malignant solid tumors","metastatic or primary malignant tumors in the pleural cavity","malignant pleural effusion","2024-12-05",{"date":429,"type":37},{"date":475,"type":37},"2024-05-15",{"date":477,"type":21},"2029-02",{"name":479,"class":72},"Suzhou Maximum Bio-tech Co., Ltd.",{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":223},"100561611","phase-1-to-evaluate-the-phase-i-clinical-study-of-jskn016-in-chinese-patients-with-advanced-malignant-solid-tumors-100561611","NCT06592417","To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* 1\\. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. The subjects were ≥18 years old on the day of signing the informed consent, male or female; 3. Subjects with histologically and\u002For cytologically confirmed advanced unresectable or metastatic epithelial malignancies that have failed or are intolerable to previous standard therapies, preferentially but not limited to the following types: AGA-positive non-small cell lung cancer, HER2 IHC 0 breast cancer, etc.\n\n  4\\. For AGA-positive NSCLC, the presence of at least one of the following mutations is required; EGFR, ALK, ROS1, NTRK, BRAF V600, MET exon 14, RET, KRAS G12C, or HER2;\n  * For the enrolled subjects, the above driver gene mutations were not tested, but the previous test results confirmed by the investigators were accepted;\n  * If only EGFR overexpression without driver gene mutation can not be included;\n  * Prior osimertinib therapy is required if EGFR T790M mutation is present;\n  * Participants had to have failed at least one prior targeted therapy and at least platinum-based chemotherapy with or without an immune checkpoint inhibitor or antiangiogenic agent; 5. Breast cancer patients with HER2 IHC 0 expression, regardless of hormone receptor (HR) expression, could be enrolled according to the results of IHC examination in our center.\n\n    6\\. At least one measurable lesion at baseline according to RECIST 1.1 criteria. Measurable disease required either no previous local treatment (e.g., radiotherapy) or evidence of disease progression after local treatment.\n\n    7\\. Expected survival time ≥3 months; 8. ECOG score 0 or 1; 9. Female subjects of childbearing potential or male subjects with a fertile partner agreed to use highly effective contraception from the time they provided written informed consent until 24 weeks after the last dose. Female subjects of childbearing potential had to have a negative serum\u002Furine pregnancy test within 7 days before randomization (for women of childbearing age, see Appendix 2).\n\n    10\\. Adequate organ function within 7 days before randomization:\n  * Bone marrow function: absolute neutrophil count ≥1.5×109\u002FL; Hemoglobin ≥90 g\u002FL; Platelet count ≥100×109\u002FL (no whole blood or blood component transfusion within 14 days before randomization; No administration of hematopoietic cytokines within 7 days before randomization).\n  * Liver function (based on the normal value of each clinical research center) : total bilirubin \\\u003C 1.5 times the upper limit of normal value (ULN, total bilirubin in subjects with liver metastasis ≤3 x ULN); ALT\u002FAST≤3×ULN (≤5×ULN in patients with liver metastasis); Albumin ≥28g\u002FL; Renal function: serum creatinine ≤1.5 times the upper limit of normal, or creatinine clearance (Ccr) calculated according to Cockcroft-Gault formula (see Appendix 4) ≥ 60 mL\u002Fmin; Coagulation function: INR or PT≤ 1.5x ULN, and aPTT≤ 1.5x ULN (low stable dose of anticoagulant, such as aspirin 100 mg\u002F day is allowed); 11. Left ventricular ejection fraction (LVEF) ≥50% (by echocardiography \\[ECHO\\]); 12. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n* 1\\. Patients with symptoms of active central nervous system metastases, except those with stable parenchymal brain metastases as assessed by investigators, were defined as seizure-free for more than 12 weeks with or without the use of antiepileptic drugs; No need for glucocorticoids; At least one MRI showed that the patient was stable on imaging. Or stable after treatment for more than 1 month without symptoms; 2. Received any investigational drug within 28 days before dosing; 3. Receipt of other antineoplastic therapy within 28 days before dose or within 5 half-lives of previous antineoplastic drugs, whichever is shorter but requires a minimum of 14 days; Received Chinese herbal medicine with clear anti-tumor indications within 14 days before drug administration; 4. Local palliative treatment within 14 days before administration; 5. Major surgical treatment (such as transabdominal or transthoracic surgery) within 28 days before drug administration; Excluding minor procedures such as diagnostic punctures or infusion device implantation or biliary stenting) or anticipated need for major surgical treatment during the study period; 6. Gastrointestinal abnormalities with obvious clinical manifestations, including but not limited to: intestinal obstruction or the presence of symptoms and signs of intestinal obstruction within 6 months before drug administration, but if the obstruction was completely removed after surgical treatment, screening could be performed (patients with previous intestinal stent implantation and the intestinal stent was not removed during the screening period were not allowed); Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess and non-gastrointestinal fistula (such as tracheoesophageal fistula) within 6 months before administration; Patients with gastrointestinal bleeding (CTCAE≥ grade 3) within 6 months before treatment, or gastrointestinal bleeding (melena, bloody stool, etc.) within 1 month before randomization were eligible if hemorrhoid bleeding was confirmed or only showed positive fecal occult blood.\n\n  7\\. Subjects with uncontrolled massive serous effusion or moderate to massive serous effusion requiring repeated drainage (recurrence within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, cachexia, etc.\n\n  8\\. Always received including the antibody coupling of topoisomerase inhibitors class I drug therapy, such as DS-8201, HER3-DXd, DS-1062, etc; 9. A history of (noninfectious) interstitial lung disease (ILD) or noninfectious pneumonia requiring steroid therapy, current ILD or noninfectious pneumonia, or ILD or noninfectious pneumonia that could not be ruled out by imaging at screening; 10. Other malignant tumors within 5 years before drug administration, Cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer (defined as stage ≤T2a, Gleason score ≤6, and at the time of prostate cancer diagnosis) were excluded Patients with PSA≤10ng\u002FmL (if measured) who had received radical treatment and had no PSA biochemical recurrence could participate in the study), in situ prostate\u002Fcervix\u002Fbreast cancer; 11. Have uncontrolled comorbidities, including but not limited to the following:\n* Active HBV or HCV infection Patients with HBsAg (+) and HBV-DNA\\\u003C 2500 copies \u002FmL or 500 IU\u002FmL were allowed to be enrolled. HCV-Ab (+) and HCV-RNA negative were allowed to enroll.\n\n  * HIV infection;\n  * Known active tuberculosis; Active syphilis;\n  * Active or uncontrolled infection requiring systemic anti-infective treatment; Uncontrolled hypertension (systolic blood pressure ≥160mmHg, Diastolic blood pressure \\> 100 mmHg), symptomatic heart failure (NYHA II-IV), unstable angina or myocardial infarction within 6 months, history of heart failure or systolic dysfunction (LVEF\\\u003C50%), or risk of QTc prolongation or arrhythmia (baseline QTc\\>470 msec) ), intractable hypokalemia, long QT syndrome, tachycardia at rest with a heart rate \\>100 bpm, atrial fibrillation or clinically symptomatic valvular heart disease (if well controlled by treatment), moderate-severe pulmonary hypertension, or a history of other arrhythmias of medical importance).\n\nNewly diagnosed thromboembolic events requiring treatment within 6 months (patients with well-controlled deep-vein thrombosis of the lower extremities or venous access ports were allowed).\n\n12\\. The toxicity of previous antineoplastic therapy did not recover to CTCAE grade ≤1 (NCI-CTCAE v5.0); Note: Subjects with stable CTCAE grade 2 toxicity related to previous antineoplastic therapy (defined as stable toxicity severity and no CTCAE grade greater than 2 within 3 months before dose administration) could be enrolled, such as: Chemotherapy-induced neurotoxicity, alopecia, skin pigmentation, fatigue, endocrine toxicity caused by previous immunotherapy (such as thyroid dysfunction, diabetes, hyperglycemia, adrenal insufficiency); 13. Previous history of allogeneic bone marrow or organ transplantation; 14. Previous history of allergic reaction or anaphylaxis to antibody drugs; 15. Previous history of severe dry eye, severe meibomian gland disease and\u002For blepharitis, keratopathy and maculopathy resulting in untreatable or delayed corneal healing of the subject; 16. Pregnant and\u002For lactating women; 17. Other conditions considered by the investigators to affect the safety or compliance of the study drug treatment, including but not limited to mental disorders, alcohol or drug abuse, etc.",{"count":487,"type":21},140,[57],"This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.",[27],"2024-09-09",{"date":493,"type":37},"2024-09-19",{"date":495,"type":37},"2024-04-30",{"date":497,"type":21},"2026-12-31",{"name":269,"class":72},{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":339,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":45},"100375216","phase-1-plasmodium-immunotherapy-for-advanced-malignant-solid-tumors-100375216","NCT04165590","Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Aged 18-70 years male or female.\n2. Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc.\n3. Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate in this study: Up to the clinical trial screening period, the imageological examination provides progression-free evidence for at least 3 months, blood brain barrier has not been damaged or is already recovered from the former treatment (surgery or radiotherapy) injury, without intracranial hemorrhage or myelorrhagia history, without metastases to the brain stem, midbrain, pons, medulla oblongata or eye subsidiary organs within 10 mm area (the optic nerve and optic chiasma).\n4. The patients have measurable tumors based on the criterion of RECIST1.1.\n5. Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before participating in the trail, the research center need to obtain the paraffin blocks or at least 6 unstained sections of the tumor tissue and the relevant pathological reports. If the above tumor tissue samples are not available, samples of any kind (such as fine needle aspiration biopsy samples, cell mass samples (such as pleural, peritoneal effusion samples and lavage samples) are acceptable. If tumor tissue is not available, patients are still eligible for the study.\n6. For the patients who previously received one or more of the following therapies, the interval time of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 28 days for patients who had received chemotherapy or radiotherapy; at least 5 half-life time for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).\n7. ECGO score is 0 to 2, and euphagia.\n8. Expected survival ≥ 3 months.\n9. WBC≥3× 10\\^9\u002FL, PLT ≥ 100× 10\\^9\u002FL, HGB ≥ 100 g\u002FL, and albumin ≥ 30 g\u002FL, no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).\n10. Patients with gastrointestinal bleeding, hemoptysis or other chronic bleeding symptoms were cured before enrollment.\n11. Patients with no severe dysfunction of cardiopulmonary, liver and kidney function (child-push grading of liver function A or B, Cr≤ 1.5 x ULN).\n12. Patient will be able to understand and sign informed consent.\n13. According to the researcher's judgment, the patient's compliance could meet the needs of follow-up.\n\nExclusion Criteria:\n\n1. Nasopharyngeal cancer, head and neck tumors.\n2. HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile.\n3. Pancreatic cancer patients.\n4. Small cell lung cancer patients.\n5. Patients with severe hemoglobin disease or severe G6PD deficiency.\n6. Patients with splenectomy or splenomegaly.\n7. Patients with drug addiction or alcohol dependence.\n8. Have not yet been washed out from the previous therapeutic effects, except the following: the bisphosphonates used for bone metastasis or osteoporosis.\n9. Uncontrolled pleural effusion, pericardial effusion or ascites.\n10. Tumor-related pain that are uncontrollable.\n11. Active malignant tumor metastasis of CNS (progression or controlling the symptoms with anticonvulsants or corticosteroids ).\n12. Patients with significant immunodeficiency detection ( CD4+T cell absolute count \\\u003C200 \u002Ful)\n13. With the following diseases or conditions: serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc.\n14. According to the principal investigator's judgment, any other diseases, metabolic disorders, abnormal results of clinical laboratory tests or physical examination, the diseases that leading to usage of the prohibited drugs, influencing the results reliability, putting patients in high risk.\n15. Have undergone major surgery within 4 weeks of the screening period, or plan to undergo major surgery during the study period, PICC catheter and central venous catheter implantation are excluded.\n16. Received any antineoplastic drugs, immune cells, antibodies, or vaccines within five drug half-life (not sure the half-life, will be subject to two weeks) during the screening period.\n17. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation.\n18. Receiving any other anti-tumor treatment at the same time.\n19. Lung function is seriously damaged, the MNW \\\u003C39% or can't get out of bed, still feel short of breath when resting.\n20. Rough cough, dyspnea, without normal diet or difficult to cooperate.\n21. Poor body condition, the researchers assess that the patients can't tolerate the Plasmodium immunotherapy.\n22. Pregnant or lactating women.\n23. Patients that are unable to comply with the research and follow-up procedure.\n24. Any case that the researchers believe that the patient does not suit for this clinical study.",{"count":507,"type":21},60,[57,24],"The purpose of this study is: 1) to evaluate the effectiveness and extended safety of the Plasmodium immunotherapy for the advanced malignant solid tumors. 2) To explore the safe and effective course of the Plasmodium immunotherapy for the advanced malignant solid tumors. 3) To explore the possible indications of Plasmodium immunotherapy for advanced malignant solid tumors.\n\nThe treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.",[27],[61,512,513],"Plasmodium immunotherapy","Plasmodiun vivax","2024-02-17",{"date":516,"type":37},"2024-02-20",{"date":518,"type":37},"2019-10-24",{"date":520,"type":21},"2026-10-31",{"name":522,"class":72},"CAS Lamvac Biotech Co., Ltd.",{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":539,"leadSponsor":541,"locationsCount":543},"100528876","phase-1-a-study-to-evaluate-the-safety-tolerance-pharmacokinetics-and-preliminary-antineoplastic-activity-of-ak132-in-advanced-malignant-solid-tumor-100528876","NCT06166472","A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor","A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The Anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.\n2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.\n3. Histologically and\u002For cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.\n4. The interval between the end of the last systemic anti-tumor treatment and the first dose should be at least 3 weeks.\n5. Subjects in the dose expansion phase are required to provide tumor tissue samples.\n6. At least one measurable tumor lesion per RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Life expectancy ≥ 3 months.\n9. Adequate organ function as assessed in the laboratory tests.\n10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.\n\nExclusion Criteria:\n\n1. There is active or untreated brain metastases,Meningeal metastases, spinal cord compression, or leptomeningeal disease.\n2. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1\u002Fmonth).\n3. Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.\n4. gastrointestinal perforation or gastrointestinal fistula within 6 months before the first dose.\n5. clinically significant bleeding symptoms or a clear tendency to bleed within 4 weeks before the first dose.\n6. Active malignant tumors within the past 3 years, except for tumors in this study and scured local tumors.\n7. History of hemolytic anemia due to any cause within 3 months before the first dose of study drug.\n8. Have a history of defects in red blood cell or hemoglobin production or metabolism.\n9. Major surgery other than the diagnosis of solid tumors within 28 days prior to the first dose or major surgery is expected during the study.\n10. Clinically significant cardiovascular or cerebrovascular disease.\n11. Presence of ≥ Grade 2 peripheral neuropathy as defined by NCI CTCAE v5.0.\n12. Presence of active diverticulitis.\n13. Patients with serious neurological or psychiatric disorders.\n14. Pregnant or lactating women.\n15. Patients who received palliative local therapy for any tumor lesions within 2 weeks prior to the first dose;and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose.\n16. Serious adverse reactions in subjects who have previously received anti-PD-1\u002FPD-L1\u002FCTLA-4 or any other immunotherapy or immuno-oncology (IO) drug.\n17. Patients who require systemic treatment with glucocorticoids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within14 days prior to the first dose.\n18. Unresolved toxicities during prior anti-tumor therapy with the exception of alopecia\u002Fpigmentation.\n19. Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to AK132 or any of its components.\n20. Previous use of any antineoplastic drug targeting the CD47-SIRPα pathway or Claudin18.2.\n21. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.\n22. Known active pulmonary tuberculosis.\n23. Patients with active hepatitis B or active hepatitis C.\n24. Known medical history of immunodeficiency or positive HIV test.\n25. Known presence of interstitial lung disease or noninfectious pneumonitis that is currently symptomatic or requires prior systemic glucocorticoid therapy that, in the judgment of the Investigator, may affect the assessment or management of toxicity related to study treatment.\n26. Patients with active infection, including those requiring intravenous antibiotics or antifungal therapy for 2 weeks prior to first dose, and unexplained fever during screening (CTCAE≥1, except those determined by the investigator to be neoplasmic).\n27. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n28. Live vaccines were administered within 28 days prior to the first dose or were planned to be administered during the study period.\n29. Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.\n30. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.",{"count":531,"type":21},72,[57],"This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor",[27],"2023-12-03",{"date":537,"type":37},"2023-12-12",{"date":537,"type":21},{"date":540,"type":21},"2026-07-24",{"name":542,"class":72},"Akeso",7]