[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Haihua Yuan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560",false,"NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[25,26,27,28,29,30,31,32,33,34],"Neoplasms","Solid Tumors","HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms","Ovarian Neoplasms",[27,36,37],"Zanidatamab","Basket Study","NOT_YET_RECRUITING","2026-06-02",{"date":41,"type":42},"2026-06-08","ACTUAL",{"date":44,"type":19},"2026-06-15",{"date":46,"type":19},"2029-12-31",{"name":48,"class":49},"Haihua Yuan","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":59,"conditions":60,"keywords":71,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100643697","phase-2-exploratory-study-on-the-efficacy-and-safety-of-trastuzumab-rezetecan-in-the-treatment-of-her2-expressiong-advanced-solid-tumor-100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":57,"type":19},15,[22],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[26,61,62,63,64,65,66,67,68,29,30,31,69,70,32,33],"Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Endometrial Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)",[72,73,74],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor",{"date":41,"type":42},{"date":44,"type":19},{"date":78,"type":19},"2028-12-31",{"name":48,"class":49},""]