[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2--gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2--gastric-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100606496","phase-2-zanidatamab-in-combination-with-pembrolizumab-and-chemotherapy-in-her2-and-pd-l1-positive-metastatic-gastroesophageal-adenocarcinoma-gea-patients-100606496",false,"NCT07176312","Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients","- ZANGEA - Phase II Study of Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients","ZANGEA","Inclusion Criteria:\n\n* Patient\\* has signed and dated a written informed consent form in accordance with regulatory and institutional guidelines and approved by an institutional Review Board \u002F Independent Ethics Committee. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n* Patient is, in the investigator's judgement, willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\n* Patient is ≥ 18 years of age at time of signing the written informed consent.\n* Patient has been diagnosed with histologically confirmed unresectable advanced\u002Fmetastatic HER2-positive (defined as IHC 3+ or IHC 2+ with ISH+) and PD-L1-positive (combined positive score CPS ≥ 1) gastroesophageal adenocarcinoma per local standard assessment of new or archival tumor tissue. Results of local HER2 and PD-L1 assessment will be retrospectively confirmed by central pathological re-assessment.\n\nNote: In case of metachronous metastases, particularly in case of prior treatment with PD-(L)1-antibodies, a fresh re-biopsy should be performed for immunohistochemistry testing (local pathology), if feasible.\n\n* Patient has assessable disease (measurable or non-measurable) per RECIST v1.1.\n* Patient did not receive previous palliative treatment. Prior adjuvant or neoadjuvant chemotherapy, immunotherapy, radiotherapy and\u002For chemoradiotherapy (but not anti HER2-targeted treatment) are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to enrolment.\n* Patient has ECOG performance status ≤ 1.\n* Patient has adequate hepatic, renal and hematologic functions:\n\n  1. Absolute number of neutrophils (ANC) ≥ 1.5 x 10\\^9\u002FL\n  2. Platelets ≥ 100x10\\^3\u002FµL\n  3. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL\u002Fmin (i.e., if serum creatinine level is \\> 1.5 x upper limit of normal (ULN), then a 24-hour urine test must be performed to check the creatinine clearance to be determined.\n  4. AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present)\n  5. Total Bilirubin ≤ 1.5 x ULN (or \\\u003C 3.0 x ULN in case of prior liver involvement or Gilbert's Syndrome)\n* Patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotrophin \\[hCG\\]) within 7 days prior to the start of study drug. Women must not be breastfeeding. WOCBP must use a highly effective method(s) of contraception during the treatment period and for 4 months after last dose of zanidatamab and\u002For pembrolizumab, or 6 months after the last dose of chemotherapy, whichever occurs last. Males who are sexually active with WOCBP must agree to remain abstinent or follow instructions for method(s) of contraception during the treatment and for 4 months after the last dose of zanidatamab and\u002For pembrolizumab, or 6 months after the last dose of chemotherapy, whichever occurs last. In addition, male subjects must be willing to refrain from sperm donation during this time.\n\n  * There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.\n\nExclusion Criteria:\n\n* Patient has any known contraindication including allergy or hypersensitivity to the trial drugs or any constituent of the products as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies.\n* Patient received prior anti HER2-targeted treatment for GEA.\n* Patient has malignancies other than the disease under study within 5 years prior to inclusion, except for those with a negligible risk of metastasis or death (e.g., expected 5-year OS \\> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).\n* Patient has untreated known CNS metastases. Patient is eligible, if previous CNS metastases are adequately treated and patient has neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for ≥ 2 weeks prior to enrolment, and did not receive corticosteroids, or is on a stable or decreasing dose of \\\u003C 10 mg daily prednisone (or equivalent) for ≥ 2 weeks prior to inclusion.\n* Patient has abnormal baseline left ventricular ejection fraction (LVEF \\\u003C 50 %), assessed by echocardiogram, multigated acquisition (MUGA) scan, or cardiac magnetic resonance imaging (MRI) scan.\n* Patient has active, known, or suspected autoimmune disease. Exception: Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical expert\u002Fsponsor be consulted prior to signing informed consent.\n* Patient has a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of trial drug administration. Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patient has persisting toxicity related to prior therapy (NCI CTCAE v.5.0 Grade \\> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n* Patient has any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with trial participation, trial drug administration, or would impair the ability of the patient to receive trial drug.\n* Patient has significant acute or chronic infections including, among others:\n* Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.\n* Patient has history of allogeneic tissue \u002F solid organ transplant.\n* Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities \\[§ 40 Abs. 1 S. 3 Nr. 4 AMG\\].\n* Patient is unable to consent because he\u002Fshe does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \\[§ 40 Abs. 1 S. 3 Nr. 3a AMG\\].\n* Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the trial medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of trial results.\n* Patient currently participates in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the trial, unless it is an observational (non-interventional) study, or during the follow-up period of an interventional study with last dose of investigational product ≥28 days prior to enrolment in this trial.\n* Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity or use of any medications known to inhibit DPD (including brivudine, sorivudine and analogs) within 4 weeks prior to enrolment.\n* Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of trial treatment.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The ZANGEA trial is a open-label, single arm, multicenter phase II trial assessing the efficacy of zanidatamab in combination with pembrolizumab and chemotherapy in patients with metastatic gastroesophageal adenocarcinoma (GEA). The patients need to be previously untreated in the palliative setting and tested positive for HER2 and PD-L1.",[27,28,29,30,31],"Gastroesophageal Adenocarcinoma","First Line Therapy","HER2 + Gastric Cancer","PDL-1","Metastases",[33,34,35,36,37],"GEA","Gastroesophageal adenocarcinoma","first line therapy","HER2-positive","PD-L1 positive","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2026-01-16",{"date":46,"type":21},"2029-03",{"name":48,"class":49},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","OTHER",20,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":76,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":59,"type":21},383,[61],"PHASE1","This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[64,65,66,67,68,69,70,71,72,73,74,29,75],"HER2 Mutation-Related Tumors","HER2","HER2-positive Breast Cancer","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","NSCLC (Non-small Cell Lung Cancer)","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2-positive Gastroesophageal Cancer",[77,78,79,80,81,82,83,84,85,86,65,87],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","2026-06-02",{"date":90,"type":42},"2026-06-04",{"date":92,"type":42},"2024-03-25",{"date":94,"type":21},"2028-12",{"name":96,"class":97},"Iambic Therapeutics, Inc","INDUSTRY",53,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100583798","phase-2-establishment-of-precision-targeted-therapy-strategies-for-advanced-gastric-cancer-based-on-novel-molecular-subtyping-100583798","NCT06881017","Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping","Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;\n3. Advanced or metastatic disease with no prior systemic therapy for advanced-stage disease (Patients who relapsed \\>6 months after completing neoadjuvant\u002Fadjuvant therapy are eligible, with prior neoadjuvant\u002Fadjuvant regimens not counted as prior lines of therapy);\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1);\n5. Archival or fresh tumor tissue sample available for biomarker testing (HER2, CLDN18.2, and PD-L1 expression);\n6. ECOG performance status: 0-1;\n7. Life expectancy ≥12 weeks;\n8. Adequate organ and bone marrow function meeting the following criteria:\n\n   1. Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days);\n   2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   3. Platelet count ≥90×10⁹\u002FL;\n   4. Total bilirubin ≤1.5×upper limit of normal (ULN);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver metastases are present);\n   6. Serum creatinine ≤1.5×ULN;\n   7. Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; QTc interval \\\u003C450 ms for males and \\\u003C470 ms for females;\n9. Coagulation parameters:\n10. For patients not on anticoagulation therapy: INR ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n11. For patients receiving full-dose or parenteral anticoagulation: Stable anticoagulant dose for ≥2 weeks prior to enrollment, with coagulation tests within the therapeutic range;\n12. Contraception requirements:\n13. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and agree to use effective contraception during the study and for 3 months after the last dose;\n14. Men must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose;\n15. Recovery from prior therapy-related toxicities to ≤Grade 1 (surgical wounds must be fully healed if applicable);\n16. Voluntary participation with signed informed consent form and anticipated adherence to protocol requirements.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to treatment, or active gastrointestinal bleeding within 3 months;\n2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage;\n3. Known history of hypersensitivity to any component of the investigational drug(s) or excipients;\n4. Prior treatments meeting any of the following:\n\n   1. Received any investigational drug within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the last investigational agent (whichever is shorter);\n   2. Concurrent enrollment in another interventional clinical study (observational or follow-up studies are permitted);\n   3. Received antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologics, or tumor embolization) within 2 weeks prior to the first dose of the study drug;\n5. History of leptomeningeal metastasis or current active brain metastases;\n6. Severe infection (CTCAE v5.0 Grade \\>2) within 4 weeks prior to the first dose of the study drug (e.g., pneumonia requiring hospitalization, bacteremia, or septic complications); active pulmonary inflammation on baseline chest imaging, or signs\u002Fsymptoms of infection requiring oral\u002FIV antibiotics within 2 weeks prior to the first dose (prophylactic antibiotics excluded);\n7. History of interstitial lung disease (except radiation pneumonitis without steroid treatment or non-infectious pneumonitis);\n8. Active tuberculosis (TB) infection confirmed by medical history or CT scan, history of active TB within 1 year prior to enrollment, or untreated active TB diagnosed \\>1 year prior to enrollment;\n9. Diagnosis of another malignancy within 5 years prior to the first dose of the study drug, except malignancies with low metastatic\u002Flethal risk (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;\n10. Pregnant or lactating women;\n11. Other conditions deemed by the investigator to jeopardize subject safety or trial integrity, including severe comorbidities (e.g., psychiatric disorders), clinically significant laboratory abnormalities, or social\u002Ffamily factors that may compromise protocol adherence or data collection.",{"count":107,"type":21},140,[24],"This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.",[111,29,112,113],"Gastric Cancer","CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction","PD-L1 Positive",[115,65,116,117],"gastric cancer","CLDN18.2","PD-L1","NOT_YET_RECRUITING","2025-03-17",{"date":121,"type":42},"2025-03-18",{"date":123,"type":21},"2025-05-01",{"date":125,"type":21},"2029-11-01",{"name":127,"class":49},"China Medical University, China"]