[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-expression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-expression":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":41,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"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",false,"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.","ALL","18 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","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.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Solid Tumors","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","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)","Head and Neck Neoplasms","Cervical Neoplasms",[42,43,44],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor","NOT_YET_RECRUITING","2026-06-02",{"date":48,"type":49},"2026-06-08","ACTUAL",{"date":51,"type":19},"2026-06-15",{"date":53,"type":19},"2028-12-31",{"name":55,"class":56},"Haihua Yuan","OTHER",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":20,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100626532","phase-1-whole-body-her2-quantification-with-89zr-trastuzumab-petct-to-asses-zr-trastuzumab-accumulation-in-her2-mutated-and-her2-overexpressing-metastatic-non-small-cell-lung-cancer-100626532","NCT07436858","Whole Body HER2 Quantification With 89Zr-Trastuzumab PET\u002FCT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed written informed consent\n* Age≥ 18 years, willing and able to comply with the protocol as judged by the investigator\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at screening.\n* Patients with histologically or cytologically confirmed diagnosis of advanced stage:\n* HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation\n* HER2 activating (insertion) mutation diagnosed through RNA sequencing (RNAseq)\n* Disease progression after at least one line of platinum-based chemotherapy ± immunotherapy and starting (new) systemic treatment.\n* Be willing to provide a recent tumor tissue specimen after the last line of therapy. Samples must be of sufficient quantity and of adequate tumor tissue content.\n* Able to undergo PET imaging procedures.\n* Measurable disease according to RECIST 1.1.\n* At least two measurable lesions with a long axis diameter ≥2 cm.\n* Adequate organ and bone marrow function within 21 days prior to tracer injection, defines as:\n\nLaboratory Test Laboratory Value Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) Hemoglobin ≥9.0 g\u002FdL or 5.6 mmol\u002FL (transfusion and\u002For growth factor support is allowed) Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL Aspartate aminotransferase \u002Falanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 ×ULN) Total bilirubin ≤1.5 × ULN if no liver metastases (\\\u003C3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases Creatinine Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n\nInternational normalised ratio (INR)\u002FProthrombin time and activated partial thromboplastin time (aPTT) ≤1.5 × (ULN), except for subjects on coumarinderivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n\n* Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n* Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n* Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3. from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Highly Effective Methods of Contraception (\\\u003C1% failure rate) include:\n\n  * Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n  * Vasectomised sexual partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Bilateral tubal occlusion\n  * Intrauterine device (provided coils are copper banded)\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation i. Oral ii. Intravaginal iii. transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral\u002Finjectable\u002Fimplantable)\n  * Intrauterine hormone-releasing system (IUS)\n  * All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.\n\nExclusion Criteria:\n\n* Contraindications for systemic treatment (as will be assigned by the treating physician)\n* Pregnant or lactating women\n* Prior allergic reaction to immunoglobulins or immunoglobulin allergy\n* Inability to comply with study procedures\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the study results\n* Prior treatment with HER2-targeted therapies (except pan HER TKIs).",{"count":64,"type":19},20,[66],"PHASE1","The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.",[69,31,70],"Lung Cancer (NSCLC)","HER2 Gene Mutation","2026-02-23",{"date":73,"type":49},"2026-02-27",{"date":75,"type":19},"2026-08-01",{"date":77,"type":19},"2030-06-01",{"name":79,"class":56},"The Netherlands Cancer Institute",1,"HER2-expression"]