[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624118":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":110,"centralContacts":115,"locations":124,"responsibleParty":165,"collaborators":168,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":109,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":109,"enrollmentInfo":181,"targetDuration":109,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":109,"overallStatus":127,"whyStopped":109,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Emory University","OTHER",[8,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 (zanidatamab, surgical resection)","EXPERIMENTAL","Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection on study followed by adjuvant chemotherapy as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT or MRI, and blood sample collection throughout the study. Patients also undergo archival tissue sample collection or biopsy during screening.",[13,14,15,16,17,18,19,20,21,22,23,24],"Biological: Zanidatamab","Procedure: Resection","Other: Patient Observation","Procedure: Echocardiography Test","Procedure: Multigated Acquisition Scan","Procedure: Endoscopic Procedure","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Procedure: Biospecimen Collection","Procedure: Biopsy Procedure","Procedure: Digital Rectal Examination","Other: Electronic Health Record Review",{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 2 (zanidatamab)","Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients then optionally undergo surgical resection or observation as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT, MRI, blood sample collection, and digital rectal exam throughout the study. Patients also undergo archival tissue sample collection or biopsy during screening.",[13,14,15,16,17,18,19,20,21,22,23,24],[30,38,45,51,57,64,70,78,87,93,99,105],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","Zanidatamab","Given IV",[9,26],[36,37],"2169946-15-8, Anti-HER2\u002FHER2 Bispecific Antibody ZW25,","HER2 x HER2 Bispecific Antibody ZW25, ZANIDATAMAB, Zanidatamab-hrii, Ziihera, ZW-25, ZW25",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"PROCEDURE","Resection","Undergo surgical resection",[9,26],[44],"Resection, resection, Surgical Resection, SURGICAL RESECTION, Surgical Resection, Surgical Resection, Surgical Resection",{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Patient Observation","Undergo observation",[9,26],[50],"active surveillance, Active Surveillance, deferred therapy, expectant management, observation, Observation, watchful waiting, Watchful Waiting",{"type":39,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Echocardiography Test","Undergo echocardiography",[9,26],[56],"EC, Echocardiography, Echocardiography, ECHOCARDIOGRAPHY, echocardiography, Echocardiography",{"type":39,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Multigated Acquisition Scan","Undergo MUGA scan",[9,26],[62,63],"Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide","Ventriculogram Scan, Radionuclide Ventriculography, Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning",{"type":39,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Endoscopic Procedure","Undergo sigmoidscopy",[9,26],[69],"Endoscopic Examination, Endoscopic Procedure, Endoscopy, ENDOSCOPY, Endoscopy, Endoscopy, endoscopy, Endoscopy, ES",{"type":39,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Computed Tomography","Undergo CT",[9,26],[75,76,77],"CAT, CAT Scan, Computed Axial Tomography, Computed Tomography, Computed Tomography,","Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography,","Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography",{"type":39,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Magnetic Resonance Imaging","Undergo MRI",[9,26],[83,84,85,86],"Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging,","Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging,","Magnetic Resonance \u002F Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI,","MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI",{"type":39,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Biospecimen Collection","Undergo blood and\u002For archival tissue sample collection",[9,26],[92],"Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection",{"type":39,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"Biopsy Procedure","Undergo biopsy",[9,26],[98],"Biopsy, BIOPSY, Biopsy, Biopsy, Biopsy, biopsy, Biopsy, Biopsy, Biopsy, Biopsy, Biopsy, BIOPSY_TYPE, BIOPSY_TYPE, BIOPSY_TYPE, Bx",{"type":39,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Digital Rectal Examination","Undergo digital rectal examination",[9,26],[104],"Digital Rectal Examination, digital rectal examination, DRE, DRE",{"type":6,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"Electronic Health Record Review","Ancillary studies",[9,26],null,[111],{"name":112,"affiliation":113,"role":114},"Olumide B. Gbolahan, MBBS, MSc","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[116,120],{"name":112,"role":117,"phone":118,"phoneExt":109,"email":119},"CONTACT","404-778-1900","ogbolah@emory.edu",{"name":121,"role":117,"phone":122,"phoneExt":109,"email":123},"Patrick Sullivan, MD, FACS","404-778-2656","patrick.s.sullivan@emory.edu",[125,139,150,156],{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":109},"Emory University Hospital Midtown","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-84.38798,33.749,{"lat":137,"lon":136},{"facility":140,"status":127,"city":128,"state":129,"zip":141,"country":131,"countryCode":132,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"Emory University Hospital","30322",{"type":134,"coordinates":143},[136,137],{"lat":137,"lon":136},[146,149],{"name":147,"role":117,"phone":109,"phoneExt":109,"email":148},"Kathleen Coleman","kathleen.marie.coleman@emory.edu",{"name":112,"role":114,"phone":109,"phoneExt":109,"email":109},{"facility":151,"status":127,"city":128,"state":129,"zip":152,"country":131,"countryCode":132,"cosmosGeoPoint":153,"geoPoint":155,"contacts":109},"Emory Saint Joseph's Hospital","30342",{"type":134,"coordinates":154},[136,137],{"lat":137,"lon":136},{"facility":157,"status":127,"city":158,"state":129,"zip":159,"country":131,"countryCode":132,"cosmosGeoPoint":160,"geoPoint":164,"contacts":109},"Emory Decatur Hospital","Decatur","30033",{"type":134,"coordinates":161},[162,163],-84.29631,33.77483,{"lat":163,"lon":162},{"type":114,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":109,"oldOrganization":109},"Olumide Gbolahan","Principal Investigator",[169],{"name":170,"class":171},"National Cancer Institute (NCI)","NIH","100624118","phase-2-zanidatamab-before-surgery-for-the-treatment-of-her2-positive-colon-and-rectal-cancer-in-patients-planned-for-curative-intent-treatment-100624118",false,"NCT07405476","Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment","A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed colon and\u002For rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers\n* Tumors must be HER2+ve (human epidermal growth factor receptor 2 \\[HER2\\] overexpression 3+ immunohistochemistry \\[IHC\\] or 2+ by IHC and positive fluorescence in situ hybridization \\[FISH\\] or HER2 amplification by next generation sequencing)\n* Tumors must have RAS wildtype genotype\n* Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Platelet count \\> 100,000 cells\u002F ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Hemoglobin \\> 9g\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Absolute neutrophil count \\> 1000 cells\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Alanine aminotransferase (ALT) ≤ 3 × ULN (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert's disease (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Glomerular filtration rate (GFR) \\> 60ml\u002Fmin (based on creatine, and Cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Adequate cardiac function with left ventricular ejection fraction of at least 50% (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n  \\* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n* Participants with stage IV colon and rectal cancer even if curative intent resection is planned\n* HER2 expression that does not meet documented inclusion criteria\n* RAS mutation\n* MSI-H or mismatch repair deficient rectal cancer\n* Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months prior to expected date of cycle 1 day 1 (C1D1) are also excluded. Previous anticancer therapy-related CHF must have been ≤ grade 1 at the time of occurrence and must have completely resolved\n* Participants receiving any other investigational agents or an investigational device within 28 days of administering the first dose of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study\n* Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","18 Years",{"count":182,"type":183},38,"ESTIMATED","INTERVENTIONAL",[186],"PHASE2","This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treatment. Zanidatamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).",[189,190,191,192,193,194,195,196,197,198,199,200],"Colon Carcinoma","Colorectal Carcinoma","Rectal Carcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","2026-04-16",{"date":203,"type":204},"2026-04-17","ACTUAL",{"date":206,"type":204},"2026-04-07",{"date":208,"type":183},"2029-12-18",{"name":5,"class":6},4]