[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Hanx Biopharmaceuticals, Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100570547","phase-1-hx009-in10018-with-or-without-standard-chemotherapy-for-advanced-solid-tumours-100570547",false,"NCT06708663","HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours","Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and sign the informed consent form;\n2. male or female, age at 18 to 70 years (including borderline value) ;\n3. expected survival ≥ 12 weeks;\n4. ECOG score 0-1;\n5. patients with unresectable\u002Fmetastatic advanced solid tumours (including biliary tract malignancies and malignant melanoma) confirmed by cytology or histopathology; Part I: Failed standard therapy, or no effective standard therapy (prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible for enrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvant therapy is permitted, but needs to have been completed at least 6 months ago);\n\nExclusion Criteria:\n\n1. Histological or pathological diagnosis of carcinoma of the jugular abdomen;\n2. Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patients with cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRK gene fusion, RET gene fusion mutation, FGFR2 gene fusion, IDH1 gene mutation, and KRAS mutation\n3. Subjects with symptomatic brain metastases, meningeal metastases, or spinal cord compression, except for the following: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no need for corticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeks as confirmed by imaging tests);\n4. have had a malignancy other than the study disease (biliary malignancy, malignant melanoma) within 5 years prior to signing the ICF, except for malignancies with negligible risk of metastasis or death and\u002For those that have received curative treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);\n5. Subjects with an active, or history of, autoimmune disease that is likely to recur or is currently being treated (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or at high risk (e.g., organ transplants requiring immunosuppressive therapy). However, subjects with the following diseases were allowed to enrol:\n\n   * Type 1 diabetes mellitus that has stabilised with the use of fixed doses of insulin;\n   * Autoimmune hypothyroidism and adrenal insufficiency requiring only hormone replacement therapy;\n   * Skin diseases that do not require systemic therapy: e.g. eczema, rashes that cover less than 10 per cent of the body surface, psoriasis without ocular symptoms.\n6. have severe cardiovascular disease such as symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina, uncontrolled hypertension (systolic blood pressure ≥160 and\u002For diastolic blood pressure ≥100 mmHg under pharmacological control), cardiac arrhythmia, history of myocardial infarction within 6 months, or history of arterial thromboembolism or pulmonary embolism within 3 months prior to the first administration of the drug\n7. suffering from a serious lung disease requiring treatment or previous serious lung disease, interstitial lung disease, interstitial pneumonitis, pulmonary fibrosis, radiation pneumonitis requiring hormonal therapy, etc;\n8. uncontrolled concomitant medical conditions including, but not limited to, severe diabetes mellitus (fasting blood glucose \\> 250 mg\u002Fdl or 13.9 mmol\u002FL), active infectious diseases, psychiatric disorders (e.g., epilepsy) that may interfere with adherence, or other serious conditions requiring systemic therapy\n9. patient with uncontrolled pleural effusions, abdominal effusions or pericardial effusions that require repeated drainage. Individuals with indwelling drains are permitted to be enrolled;","ALL","18 Years","70 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma",[28,29],"Biliary Tract Cancer","Melanoma","RECRUITING","2026-04-15",{"date":33,"type":34},"2026-04-16","ACTUAL",{"date":36,"type":34},"2025-01-17",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Hangzhou Hanx Biopharmaceuticals, Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":42},"100570131","phase-1-a-phase-2-study-of-hx301-in-patients-with-high-grade-giloma-100570131","NCT06703255","A Phase 2 Study of HX301 in Patients with High-grade Giloma","A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)","Inclusion Criteria:\n\n1. Signed informed consent form;\n2. Age ≥ 18 years;\n3. Expected survival ≥ 12 weeks;\n4. Part I:1) Histologically confirmed high-grade glioma (WHO classification grade III or IV); 2) At least one prior temozolomide treatment; 3) Patients with recurrent or progressive clinically assessed disease according to RANO criteria with evaluable lesions; Part II: Patients with histological or cytological diagnosis of glioblastoma according to World Health Organization (WHO) classification (2021) who received surgical treatment for the first time and standard concurrent chemoradiotherapy and who have not received any other prior treatment;\n5. Part II: Subjects must undergo partial or complete surgical resection, and available results of postoperative brain contrast-enhanced MRI were documented as follows: 1) complete resection without gadolinium enhancement ; or 2) complete resection (80% or more);\n6. Part II: Subjects must complete initial radiotherapy combined with TMZ (concurrent chemoradiotherapy) for glioblastoma according to the Stupp regimen (Stupp 2005) (total radiation dose 5 4-60 G y);\n7. Part I: If radiotherapy has been performed, the completion of radiotherapy shall last for 3 months, or there shall be tumor progression or histopathological confirmation of progression in the original radiation field within 3 months; Part II: there shall be no evidence of disease progression after chemoradiotherapy, except for pseudo progression;\n8. Dexamethasone was administered at ≤ 5 mg\u002Fday at study entry.Corticosteroids should be reduced as far as possible to the smallest dose necessary to control neurological symptoms before receiving study treatment;\n9. Karnofsky performance status (KPS) ≥ 70 within 1 4days prior to receiving study treatment ;\n10. Willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n1. Part II: Patients with recurrent glioblastoma;\n2. Distant metastasis involving brainstem and meninges or extension of lesions to spinal cord;\n3. Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive and HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive and HBV DNA positive (HBsAg positive requires further detection of HBV DNA, HBV DNA ≥ 200 IU\u002Fml, or ≥ 10 3 copies\u002Fml);\n4. Hypersensitivity to temozolomide and\u002For components of HX301;\n5. At risk for torsades de pointes (TdP): patients with a marked prolongation of the QT\u002FQTc interval calculated using the Fredericia QT correction formula at baseline (eg, repeated demonstration of QTc interval \\> 470 ms), or a history of other TdP risk factors (eg, heart failure, hypokalemia, family history of long QT syndrome), or patients who are currently taking medications that prolong the QT\u002FQTc interval;\n6. Grade ≥ 2 diarrhea at baseline;\n7. Participation in another study involving an investigational drug within 30 days prior to the first dose of study drug;",{"count":51,"type":21},72,[24,25],"The study will include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes.",[55],"Glioma","2025-01-13",{"date":58,"type":34},"2025-01-15",{"date":60,"type":34},"2025-01-08",{"date":38,"type":21},{"name":40,"class":41},""]