[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641170","early-phase-1-iaso207-injection-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100641170",false,"NCT07574346","IASO207 Injection in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Single-arm, Dose-escalation Clinical Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of IASO207 Injection in Subjects With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old and ≤ 75 years old.\n* 2\\. Previously diagnosed by histopathological biopsy as one of the following pathological types:\n\n  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS); high-grade B-cell lymphoma (HGBL);\n  2. DLBCL transformed from indolent lymphoma, including transformation from follicular lymphoma (FL) or marginal zone lymphoma (MZL), and DLBCL transformed from CLL\u002FSLL (Richter transformation);\n  3. Grade 3B follicular lymphoma (FL3B); primary mediastinal large B-cell lymphoma (PMBCL).\n* 3\\. Recurrent\u002Frefractory B-cell lymphoma patients who have failed standard treatment (including recurrence, non-response, progression) must have received a standard immunotherapy regimen containing CD20 monoclonal antibody and anthracycline drugs:\n\n  * Recurrent disease refers to the occurrence of disease recurrence or progression ≥ 12 months after treatment;\n  * Refractory disease refers to disease progression during treatment or best response of disease stability (SD), or recurrence within 12 months after autologous hematopoietic stem cell transplantation, or disease progression within 12 months after treatment.\n* 4\\. Before enrollment, it is confirmed that CD19 target expression is positive:\n\n  1. Previous pathological results indicate positive CD19 expression, and\u002For;\n  2. Can provide archived or fresh puncture specimens to the central laboratory for detection to confirm positive CD19 expression.\n* 5\\. According to the Lugano 2014 standard, there is at least one measurable lesion (lymph node lesion LDi \\> 1.5 cm, extranodal lesion LDi \\> 1.0 cm);( LDi is longest diameter)\n* 6\\. ECOG score 0-2;\n* 7\\. Expected survival period ≥ 12 weeks;\n* 8\\. Screening period examination confirms appropriate organ function: i. Blood routine: absolute neutrophil count (ANC) ≥ 1×109\u002FL; platelets (PLT) ≥ 50×109\u002FL; hemoglobin (Hb) ≥ 70g\u002FL (must not have received any G-CSF\u002FGM-CSF treatment or red blood cell and platelet transfusion within 7 days before laboratory examination); ii. Peripheral blood T lymphocyte absolute count ≥ 300 cells\u002FμL; iii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); serum total bilirubin ≤ 1.5× ULN (for patients with tumor liver metastasis: ALT\u002FAST ≤ 5× ULN; TBil ≤ 3× ULN); iv. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; v. Pulmonary function: oxygen saturation at rest ≥ 91%; vi. Renal function: calculated creatinine clearance rate (CrCl) ≥ 40 ml\u002Fmin according to Cockcroft-Gault formula; vii. Coagulation function: fibrinogen ≥ 1.0g\u002FL; activated partial thromboplastin time (aPTT) ≤ 1.5× ULN, prothrombin time (PT) ≤ 1.5× ULN;\n* 9\\. Pregnant participants should agree to take effective contraceptive measures or drugs from the date of signing the informed consent form until at least 1 year after the last administration of IASO207 injection.\n\nExclusion Criteria:\n\n* 1\\. There is invasion of central nervous system tumors; and\u002For primary central nervous system DLBCL, primary testicular LBCL.\n* 2\\. The tumor involves the small intestine, colon, and\u002For imaging examination indicates that the tumor involves the sub-mucosal layer of the gastrointestinal tract, and the patient has been evaluated to have a risk of organ perforation.\n* 3\\. Within the past 5 years before screening, the subject has had other malignant tumors except for the disease under study, excluding cervical carcinoma in situ after radical treatment, basal cell or squamous cell skin cancer after radical treatment, local prostate cancer, breast duct carcinoma in situ or thyroid papillary carcinoma.\n* 4\\. Infectious disease screening meets one of the following conditions: i. The subject has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal peripheral blood HBV DNA test (abnormal HBV DNA test is defined as: HBV DNA quantitative test higher than the detection center's lower limit or higher than the normal reference range of the detection center or HBV DNA qualitative test positive); ii. The subject has positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA; iii. The subject has positive human immunodeficiency virus (HIV) antibody; iv. The subject has syphilis; v. The subject is an active CMV infection patient.\n* 5\\. Before enrollment, there is uncontrollable active bacterial, fungal or viral infection: i. There are persistent symptoms\u002Fsigns related to infection that require intravenous anti-infection drug treatment; ii. After appropriate anti-infection treatment, the clinical symptoms and examinations do not indicate improvement.\n* 6\\. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA functional classification standard ≥ III), severe arrhythmia.\n* 7\\. Within the past 6 months before screening, the subject has had central nervous system diseases or histories, such as epilepsy, paralysis, aphasia, cerebral infarction, cerebral hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome (such as cerebral aneurysm, epilepsy, stroke \\[except lacunar infarction\\], senile dementia, psychosis, etc.) or patients with consciousness disorders.\n* 8\\. The subject has received any CD19-targeted treatment before.\n* 9\\. The subject has received any allogeneic hematopoietic stem cell transplantation (Allo-HSCT), autologous CAR-T and other allogeneic donor cell adoptive therapy.\n* 10\\. The subject with a large mass (diameter of the lesion \\> 7.5 cm) is not included in this study; patients whose disease progresses too rapidly and is expected not to benefit from the treatment of this study will not be included in this study.\n* 11\\. Before enrollment, the subject does not meet the drug\u002Ftreatment washout period: i. The subject needs or is continuously using systemic corticosteroids or other immunosuppressants within 4 weeks before enrollment; ii. The subject has received bispecific antibody, autologous hematopoietic stem cell transplantation, autologous CAR-T treatment within 12 weeks before enrollment; iii. The subject has received radiotherapy or grade 4 major surgery within 4 weeks before enrollment; or plans to undergo general anesthesia surgery within 12 weeks after receiving the study treatment.\n\niv. Using monoclonal antibodies, cytotoxic chemotherapy, or ADC drugs within 4 weeks prior to enrollment; v. Having received vaccination or any off-label clinical study drug treatment within 4 weeks prior to enrollment.\n\n* 12\\. Judged by the investigator, there are other unstable systemic diseases: including but not limited to severe liver, kidney or metabolic diseases that require treatment.\n* 13\\. The adverse reactions caused by previous anti-tumor treatment have not been alleviated to ≤ grade 2 (NCI-CTCAE v5.0 version).\n* 14\\. Those with a history of allergic reactions to the excipient components of IASO207 injection.\n* 15\\. Those who have received solid organ transplantation in the past.\n* 16\\. Pregnant or lactating women.\n* 17\\. Other situations deemed by the investigator as not suitable for enrollment.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of IASO207 Injection in patients with Relapsed\u002FRefractory B-cell Malignancies。",[27],"Malignancies",[29,30,31,32],"Relapsed","Refractory","B-cell malignancies","IASO207","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2026-05-29",{"date":41,"type":21},"2042-04-30",{"name":43,"class":44},"Peking University People's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100640781","phase-1-a-phase-i-study-of-jl19001-injection-alone-or-in-combination-with-standard-therapy-in-patients-with-advanced-solid-tumors-or-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100640781","NCT07603479","A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.\n2. Disease Status: Patients with histologically or cytologically confirmed advanced solid tumors (AST) or relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (r\u002Fr B-NHL) who have failed standard therapy, have no available standard treatment options, are intolerant to, or refuse standard therapy. This includes, but is not limited to, melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone B-cell lymphoma (MZL). Specific requirements for each tumor type are as follows:\n\n   Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include at least one immune checkpoint inhibitor (ICI; e.g., pembrolizumab, toripalimab, pucotenlimab, ipilimumab + nivolumab, atezolizumab) and at least one chemotherapy (e.g., dacarbazine, temozolomide, paclitaxel, nab-paclitaxel, cisplatin\u002Fcarboplatin, fotemustine). For patients with BRAF V600, NRAS, or KITmutations, prior treatment must include at least one targeted therapy against the specific mutation and one ICI (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   RCC: Metastatic or unresectable clear cell RCC with PD after ≥1 prior line of therapy or intolerance to ≥1 prior line. Prior treatment must include at least one targeted therapy (e.g., sunitinib, pazopanib, sorafenib, axitinib, lenvatinib, anlotinib, vorolanib + everolimus) and one ICI (e.g., toripalimab, pembrolizumab, benmelstobart, nivolumab, ipilimumab).\n\n   NSCLC: Stage IV NSCLC with PD after ≥2 prior lines of systemic therapy. For patients without driver alterations: Prior treatment must include at least one ICI (e.g., pembrolizumab, camrelizumab, tislelizumab, sintilimab, atezolizumab, sugemalimab, toripalimab, penpulimab, serplulimab, nivolumab + ipilimumab, ivonescimab) and\u002For platinum-based chemotherapy, plus one single-agent therapy (e.g., docetaxel, pemetrexed, gemcitabine, paclitaxel, vinorelbine, anlotinib).\n\n   For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations, or HER2mutations): Prior treatment must include at least one targeted therapy against the specific alteration and one platinum-doublet chemotherapy or single-agent therapy (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   SCCHN: Metastatic head and neck squamous cell carcinoma with PD after ≥2 prior lines of systemic therapy.\n\n   Non-nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and either an ICI (e.g., pembrolizumab, finotonlimab, toripalimab, nivolumab) or an EGFR monoclonal antibody (e.g., cetuximab).\n\n   Nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and an ICI (e.g., camrelizumab, toripalimab, tislelizumab, penpulimab, tagitanlimab). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   r\u002Fr B-NHL: PD after ≥2 prior lines of systemic therapy. Prior treatment must include a regimen containing an approved CD20 antibody (e.g., rituximab, zuberitamab, ripertamab).\n\n   Note: The later-line treatment status for all patients will be determined by the Investigator.\n3. Measurable Disease: Presence of at least one evaluable tumor lesion according to RECIST 1.1 (solid tumors) or Lugano criteria (lymphoma). Note: Lesions previously irradiated are not considered target lesions unless there is documented progression within the irradiated field or persistence of the lesion \\>3 months after radiotherapy.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (refer to Appendix 1: ECOG Performance Status).\n5. Laboratory Parameters: Adequate organ function within 14 days prior to enrollment, defined as:\n\n   Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet Count (PLT) ≥ 100 × 10⁹\u002FL Hemoglobin (HGB) ≥ 90 g\u002FL Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Serum Creatinine ≤ 1.5 × ULN, or Calculated Creatinine Clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN International Normalized Ratio (INR) ≤ 1.5 × ULN\n6. Life Expectancy: Expected survival ≥ 12 weeks.\n7. Contraception and Pregnancy:\n\n   Participants of childbearing potential and their partners must agree to use highly effective non-pharmacological contraceptive methods during the study and for at least 12 weeks after the last dose.\n\n   Female participants of childbearing potential who are not surgically sterile must have a negative serum β-human chorionic gonadotropin (β-HCG) test within 7 days prior to the first dose and must not be breastfeeding.\n8. Consent and Compliance: Ability to understand and voluntarily sign the ICF, and willingness to comply with scheduled visits as per protocol.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be ineligible for this study:\n\n1. Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.\n2. CNS Metastases:\n\n   Patients with active central nervous system (CNS) metastases and\u002For carcinomatous meningitis are excluded.\n\n   However, the following patients are allowed:\n\n   ① Asymptomatic brain metastasis: No progressive CNS symptoms attributed to brain metastases, not requiring corticosteroids or requiring ≤ 10 mg\u002Fday prednisone (or equivalent), and lesion size ≤ 1.5 cm. These patients require regular brain imaging as a disease assessment site.\n\n   ② Treated brain metastases: Stable brain metastases for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart post-treatment), with no evidence of new or enlarging lesions, and discontinued steroids ≥ 3 days prior to the first dose. Stability must be established prior to the first dose.\n3. Cardiac Conditions: Any of the following cardiac conditions:\n\n   1. QTc interval \\> 450 ms (male) or \\> 470 ms (female).\n   2. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n   3. Unstable angina, new-onset angina, or myocardial infarction within 6 months prior to screening.\n   4. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block, or PR interval \\> 250 ms.\n   5. Valvular heart disease ≥ Grade 2 (CTCAE).\n   6. Left ventricular ejection fraction (LVEF) \\\u003C 50% as measured by echocardiogram.\n   7. Uncontrolled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\> 100 mmHg); orthostatic hypotension or drug-induced hypotension (systolic BP \\\u003C 90 mmHg or diastolic BP \\\u003C 60 mmHg).\n   8. Uncontrolled systemic disease despite regular treatment (e.g., diabetes).\n4. Prior Immune Toxicity: History of prior immunotherapy with ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-mediated myocarditis.\n5. Coagulopathy: Hereditary bleeding diathesis or coagulopathy, or history of clinically significant bleeding disorders or arterial\u002Fvenous thromboembolism (e.g., cerebrovascular events, deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose.\n6. Autoimmune Disease: Active autoimmune diseases such as systemic lupus erythematosus, rheumatic diseases, Crohn's disease, ulcerative colitis, etc.\n7. GI Perforation\u002FFistula: History of gastrointestinal perforation\u002Ffistula or risk factors for perforation within 6 months prior to the first dose.\n8. GI Bleeding: Any ≥ Grade 3 gastrointestinal bleeding within 12 weeks prior to the first dose.\n9. Transplantation: Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.\n10. Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or clinically significant active pneumonitis at screening (excluding radiation-induced fibrosis not requiring steroid treatment).\n11. Effusions: Uncontrollable pleural effusion, pericardial effusion, or ascites, in the judgment of the Investigator.\n12. Other Malignancies: History of any other active malignancy within 3 years prior to the first dose (except for curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or cancers with a disease-free survival \\> 1 year after radical treatment).\n13. Surgery\u002FTrauma: Major surgical procedure (excluding core needle biopsy) or significant traumatic injury within 4 weeks prior to the first dose, or planned elective surgery during the study period.\n14. Prior Anticancer Therapy: Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose. Specific washout periods:Nitrosoureas or mitomycin C (within 6 weeks); oral fluoropyrimidines or small molecule targeted drugs (within 2 weeks); traditional Chinese medicine with anti-tumor indications (within 2 weeks).\n15. Toxicity Recovery: Failure to recover from prior anticancer therapy toxicities to ≤ Grade 1 (per CTCAE v6.0), except for toxicities deemed safe by the Investigator (e.g., alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement).\n16. IL-2\u002FIL-15 Agonists: Receipt of IL-2 or IL-15 agonist therapy within 4 weeks prior to the first dose.\n17. Immunomodulators: Receipt of immunomodulatory drugs (including but not limited to thymosin, interferon) within 2 weeks prior to the first dose.\n18. Corticosteroids\u002FImmunosuppressants: Receipt of systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapies within 2 weeks prior to the first dose. Exceptions:Use of topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., contrast allergy prevention).\n19. Tuberculosis: Active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis \\> 1 year ago without adequate standard treatment.\n20. Active Infection: Serious infection requiring intravenous antibiotics or hospitalization within 4 weeks prior to the first dose.\n21. Viral Infections: Active viral infections, including:\n\n    Active hepatitis B (HBsAg or HBcAb positive and HBV DNA \\> upper limit of normal).\n\n    Active hepatitis C (HCV antibody positive and HCV RNA \\> upper limit of normal).\n\n    Human Immunodeficiency Virus (HIV) infection. Syphilis infection. Note: Patients receiving prophylactic antiviral therapy (excluding interferon) are permitted.\n22. Vaccinations: Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose or anticipated receipt during the study period.\n23. Other: Any other severe physical or psychiatric illness, laboratory abnormality, or other condition that, in the judgment of the Investigator, would increase the risk to the participant, interfere with study results, or make participation inappropriate.",{"count":53,"type":21},14,[55],"PHASE1","This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r\u002Fr B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg\u002Fkg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.",[27,58,59,60],"Solid Malignant Tumor","NHL (Non-Hodgkin Lymphoma)","Solid Tumor Cancer","NOT_YET_RECRUITING","2026-05-18",{"date":64,"type":37},"2026-05-22",{"date":66,"type":21},"2026-05",{"date":68,"type":21},"2030-05",{"name":70,"class":71},"Jecho Biopharmaceuticals Co., Ltd.","INDUSTRY",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100510673","phase-2-phase-2-open-label-single-arm-study-on-the-use-of-metformin-as-adjunctive-therapy-in-high-grade-glioma-100510673","NCT05929495","Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;\n* hypomethylation or hypermethylation of MGMT assessed post-surgery;\n* adult patients (≥18 years), both sexes;\n* Patients undergoing Stupp protocol including patients aged \\> 70 years performing the hypofractionated protocol and three weeks of chemotherapy;\n* Karnofsky Performance Status (KPS)\\> 60 assessed post-surgery;\n* life expectancy at least 6 months defined by size and location of lesion tumor;\n* freely given written informed consent prior to any activity related to the study. Patients must be able to communicate with the investigator and comply with the study procedures;\n* Women of childbearing age must test negative for pregnancy at enrollment and, if they have sexual intercourse, they must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless they are permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study.\n* Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n* Multicenter GBMs;\n* Patients diagnosed with diabetes or diabetes-related conditions;\n* other active malignancies;\n* hypersensitivity, intolerance to metformin or excipients;\n* Impaired renal function with creatinine clearance \\\u003C 60 mL\u002Fmin assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use;\n* taking metformin, insulin or other biguanides, regardless of the reason;\n* pregnancy or lactation;\n* patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study.",{"count":79,"type":21},25,[81],"PHASE2","About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies.\n\nThis is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months.\n\nThe clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.",[84,85,27],"Glioblastoma, IDH-wildtype","Metformin",[85,87,88],"Gliomas","GBM","2025-07-24",{"date":91,"type":37},"2025-07-25",{"date":93,"type":37},"2024-02-12",{"date":95,"type":21},"2026-01-01",{"name":97,"class":44},"University of Milano Bicocca"]