[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-solid-tumor":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,84],{"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":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100479512","phase-1-clinical-trial-of-yh32367-in-patients-with-her2-positive-locally-advanced-or-metastatic-solid-tumor-100479512",false,"NCT05523947","Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor","A Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n\\[Dose Escalation Part\\]\n\n* Pathologically confirmed HER2-positive\n* Mandatory provision of tumor tissue sample\n\n\\[Dose Expansion Part\\]\n\n* Patients who have at least one measurable lesion\n* Mandatory provision of tumor tissue sample\n\n  1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer\n  2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer\n\nExclusion Criteria:\n\n* Uncontrolled central nervous system (CNS) metastases\n* Spinal cord compression\n* Carcinomatous meningitis\n* Acute coronary syndromes\n* Heart failure\n* Interstitial lung disease (ILD)\n* Pneumonitis\n* History of a second primary cancer\n* Human immunodeficiency virus (HIV)\n* Active chronic hepatitis B\n* Hepatitis C\n* Systemic steroid therapy\n* Autoimmune disease","ALL","18 Years",{"count":19,"type":20},147,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.",[27],"HER2-Positive Solid Tumor",[29,30,31,32,33,34,35],"YH32367","HER2\u002F4-1BB bispecific antibody","Solid tumor","Breast cancer","Gastric cancer","HER2-positive","Biliary tract cancer","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2022-08-26",{"date":44,"type":20},"2028-04-30",{"name":46,"class":47},"Yuhan Corporation","INDUSTRY",19,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":70,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560","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.",{"count":56,"type":20},10,[24],"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.",[60,61,62,63,64,65,66,67,68,69],"Neoplasms","Solid Tumors","HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms","Ovarian Neoplasms",[62,71,72],"Zanidatamab","Basket Study","NOT_YET_RECRUITING","2026-06-02",{"date":76,"type":40},"2026-06-08",{"date":78,"type":20},"2026-06-15",{"date":80,"type":20},"2029-12-31",{"name":82,"class":83},"Haihua Yuan","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100593649","early-phase-1-tgw211-for-click-cleavable-imaging-in-her2-positive-cancers-100593649","NCT07009184","TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.","TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers, a Phase 0\u002FI Study.","CleavHER","Inclusion Criteria:\n\n1. Signed, written informed consent and willing and able to comply with study requirements.\n2. Male or Female aged ≥ 18 years.\n3. Histologically confirmed HER2-positive cancer (IHC 3+ or IHC 2+ AND FISH+) with at least 1 measurable target lesion of at least 10 mm on CT or MRI based on RECIST v1.1, assessed by the investigator to enable adequate SPECT\u002FCT imaging.\n4. WHO performance status (ECOG) of 0 or 1.\n5. Adequate organ and bone marrow function, evidenced by the following laboratory results:\n\n   1. Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002Fl;\n   2. Platelet count ≥ 100 x 10\\^9 \u002Fl;\n   3. Hemoglobin ≥ 9.0 g\u002Fdl or 5.6 mmol\u002Fl;\n   4. Total bilirubin ≤ 1.5 x the upper limit of normal (ULN);\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases);\n   6. Serum creatinine ≤ 1.5 x ULN; - Estimated Glomerular Filtration Rate (eGFR)\\* ≥ 60 ml\u002Fmin\u002F1.73 m2 ; \\*preferably calculated with CKD-EPI formula.\n\nExclusion Criteria:\n\n1. Medical history of myocardial infarction within 6 months before participation or symptomatic CHF (New York Heart Association Class III to IV).\n2. QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec on screening ECG or congenital long QT syndrome.\n3. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids or has current or suspected ILD\u002Fpneumonitis.\n4. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g, pulmonary embolism within 3 months of trial participation, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.).\n5. Has an uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals.\n6. Participation in another clinical study with an investigational product during the past 6 weeks.\n7. Concurrent enrolment in another clinical study unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.\n8. Pregnant or breastfeeding women, where pregnancy is defined as the time between conception and termination of gestation, confirmed by a positive urinary or serum pregnancy test.\n9. Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant and no evidence of post-menopausal status, unless they use highly effective methods of contraception or abstain from sexual activity for 30 days after investigational drug administration. Male partners of female patients should also use a condom during intercourse for 30 days after investigational drug administration to the partner to prevent them from fathering a child.\n10. Male patients in the reproductive age, not willing or able to use a condom or abstain from sexual activity for 30 days after investigational drug administration. WOCBP partners of sexually active male patients should also use a highly effective contraception method during intercourse for 30 days after investigational drug administration of the partner.\n11. Known allergy or hypersensitivity to any of the investigational drugs or its excipients.\n12. Any condition which, in the opinion of the investigator, would preclude participation in the study.\n13. Second active malignancy.",{"count":48,"type":20},[94],"EARLY_PHASE1","In recent years, there is increasing interest in antibodies for imaging, antibody-drug conjugates (ADC) and targeted radionuclide therapy (TRT). With these techniques, antibodies are used as a vector to deliver a cytotoxic drug or radionuclide for therapy or nuclear medicine imaging. One such antibody-based vector suitable for delivering a cytotoxic drug or radionuclide is trastuzumab, which targets HER2 that is overexpressed in cancers such as breast, gastric and gastroesophageal junction carcinomas. Unfortunately, antibodies generally have a very long circulation time (\\>20-30 days) that often result in unfavorable background noise in the healthy organs in imaging or toxicity when trastuzumab is bound to a therapeutic radionuclide for radioimmunotherapy. There is thus a need to increase the speed of excretion of antibodies or release the antibody from its payload. Ideally, the clinician would like to appropriately time the elimination of radioactivity to achieve an optimal tumor to non-tumor ratio. To this aim, Tagworks Pharmaceuticals developed a new class of chemically cleavable radiolabeled conjugates that release the radiolabel on demand upon reaction with a small molecule \"the trigger\" (TRG001).",[62],"2025-11-14",{"date":99,"type":40},"2025-11-18",{"date":101,"type":20},"2025-12-10",{"date":103,"type":20},"2026-12",{"name":105,"class":83},"Radboud University Medical Center",1,"HER2-positive Solid Tumor"]