[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MegaPro Biomedical Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100411889","phase-1-phase-12a-study-of-mpb-1734-in-patients-with-advanced-solid-tumors-100411889",false,"NCT04643418","Phase 1\u002F2a Study of MPB-1734 in Patients With Advanced Solid Tumors","Phase 1\u002F2a Dose-ranging, Safety, Pharmacokinetics, and Preliminary Efficacy Study of MPB-1734 in Patients With Advanced Solid Tumors in Part 1 and With Selected Solid Tumors in Part 2","Inclusion Criteria:\n\n1. Signed informed consent in the local language prior to any study-mandated procedure.\n2. Male or female patients at least 18 years of age, at the time of informed consent.\n3. Male or nonpregnant and nonlactating female patients with pathologically confirmed, measurable solid tumor lesions (Response Evaluation Criteria in Solid Tumors version 1.1 \\[RECIST 1.1\\]) that are unresectable, and standard therapy able to provide clinical benefit does not exist or is no longer effective.\n4. Eastern Cooperative Oncology Group Performance Status ≤2.\n5. Patients have recovered from the acute toxicity of previous therapies (peripheral sensory neuropathy recovered to ≤Grade 2) except alopecia, and:\n\n   * At least 4 weeks have elapsed since completing surgery, endocrine therapy, tyrosine kinase inhibitor therapy, immunotherapy, radiotherapy, chemotherapy, and\u002For\n   * At least 6 weeks have elapsed since completing chemotherapy with nitrosoureas, melphalan, and\u002For mitomycin C, and\u002For\n   * At least 6 weeks have elapsed since completing cranial radiotherapy.\n6. Life expectancy of greater than 12 weeks.\n7. Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Peripheral sensory neuropathy \\>Grade 2 (CTCAE version 5.0) at baseline.\n2. Patients requiring immediate palliative treatment of any kind including surgery and\u002For radiotherapy.\n3. Serum bilirubin \\>1.5× ULN.\n4. AST and\u002For ALT \\>2.5× ULN if no liver involvement, OR AST and\u002For ALT \\>5× ULN with liver involvement.\n5. Serum creatinine \\>1.5× ULN, and\u002For a creatinine clearance of \\\u003C50 mL\u002Fmin calculated by Cockcroft Gault.\n6. QTc prolongation defined as a QTc with Framingham correction greater than or equal to 470 ms, or significant electrocardiogram (ECG) abnormalities.\n7. Known hypersensitivity to taxanes or any excipients of the drug formulation.\n8. Female patients who are pregnant, breast-feeding, or planning to become pregnant during the study.\n9. Untreated and\u002For uncontrolled central nervous system metastases.\n10. Patients with brain tumors, primary or metastatic.\n11. Patients taking concomitant medications anticipated to result in drug-drug interactions.","ALL","18 Years",{"count":19,"type":20},81,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human (FIH), multicenter, open-label, uncontrolled, Phase 1\u002F2a study with dose escalation in patients with advanced solid tumors (Part 1) and cohorts of up to 15 patients per selected indication (Part 2). The solid tumor types in Part 2 will be decided by the sponsor prior to the start of Part 2, but not be solely based on the efficacy results in Part 1.",[27],"Solid Tumor, Unspecified, Adult","RECRUITING","2025-10-30",{"date":31,"type":32},"2025-11-03","ACTUAL",{"date":34,"type":32},"2022-03-08",{"date":36,"type":20},"2025-12",{"name":38,"class":39},"MegaPro Biomedical Co. Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100557617","phase-1-pilot-study-of-mpb-2043-enhanced-mri-for-nodal-staging-in-head-and-neck-squamous-cell-carcinomas-100557617","NCT06540443","Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas","A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Subjects aged 20 years and above\n* Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery\n* Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.\n* Subjects must be nonlactating.\n* Subjects must be able to understand and be willing to sign a written informed consent document.\n* Subjects must be able to comply with the study protocol.\n\nExclusion Criteria:\n\n* Subjects with contraindications to MRI\n* Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).\n* Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.\n* Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.\n* Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.\n* Subjects with kidney disease or impairment.\n* Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.\n* Subjects with active hepatitis B or hepatitis C infection.\n* Subjects with bone marrow disorders or a history of a bone marrow transplant.","20 Years",{"count":50,"type":20},24,[23],"This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg\u002Fkg, 1 mg\u002Fkg, 2 mg\u002Fkg, and 3 mg\u002Fkg) and assesses the optimal timing for post-dose imaging using T1\u002FT2\u002FT2\\*-weighted sequences to improve the accuracy of nodal staging.",[54,55],"Head and Neck Squamous Cell Carcinoma","Lymph Node Metastasis","2025-05-05",{"date":58,"type":32},"2025-05-08",{"date":60,"type":32},"2024-12-19",{"date":62,"type":20},"2026-09",{"name":38,"class":39},""]