[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535595":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":30,"armGroups":64,"interventions":71,"overallOfficials":77,"centralContacts":81,"locations":86,"responsibleParty":575,"collaborators":30,"id":577,"slug":578,"hasResults":579,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":30,"eligibilityCriteria":583,"healthyVolunteers":579,"sex":584,"minAge":585,"maxAge":30,"enrollmentInfo":586,"targetDuration":30,"studyType":589,"phases":590,"briefSummary":592,"conditions":593,"keywords":607,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":628},{"fullName":5,"class":6},"Iambic Therapeutics, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":30},[9,13,17,21,25,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)","Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1","21 days",{"measure":14,"description":15,"timeFrame":16},"Incidence and severity of adverse events (AEs)","Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)","Through 30 days after the last dose of study drug",{"measure":18,"description":19,"timeFrame":20},"Pharmacokinetic (PK) parameters","PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).","Up to 42 days",{"measure":22,"description":23,"timeFrame":24},"Confirmed objective response rate (cORR)","Percentage of participants who achieve a confirmed objective response (complete response \\[CR\\] + partial response \\[PR\\]) per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1","Through study completion, estimated as 46 months",{"measure":26,"description":27,"timeFrame":24},"Confirmed central nervous system ORR (CNS-cORR)","Percentage of participants who achieve a confirmed CNS-cORR (CNS-CR + CNS-PR) per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria",{"measure":29,"description":30,"timeFrame":16},"Frequency of IAM1363 dose modifications, including treatment discontinuations",null,{"measure":32,"description":30,"timeFrame":33},"Incidence and severity of clinical laboratory abnormalities","Through 30 days post last dose of study drug",{"measure":35,"description":36,"timeFrame":16},"Incidence of ECG abnormalities","As measured using standard ECG parameters, including pulse rate, QT intervals, and QRS duration.",[38,41,44,47,50,53],{"measure":39,"description":40,"timeFrame":24},"Best overall response (BoR) rate","BoR defined as the best response per RECIST v1.1 and RANO-BM across all assessments",{"measure":42,"description":43,"timeFrame":24},"Duration of response (DoR)","DoR defined as the time between the first confirmed objective response per RECIST v1.1 and RANO-BM and date of disease progression per RECIST v1.1 and RANO-BM or death due to any cause",{"measure":45,"description":46,"timeFrame":24},"Disease control rate (DCR)","DCR defined as the percentage of participants who achieve CR or PR, or stable disease (SD) per RECIST v1.1 and RANO-BM",{"measure":48,"description":49,"timeFrame":24},"Clinical benefit rate (CBR)","CBR defined as the percentage of participants who achieve CR, PR, or SD per RECIST v1.1 and RANO-BM consecutively for 3 months",{"measure":51,"description":52,"timeFrame":24},"Progression-free survival (PFS)","PFS defined as the number of months from the date of first study treatment administration to the earliest of documented progressive disease per RECIST v1.1 and RANO-BM or death without prior progression",{"measure":54,"description":55,"timeFrame":24},"Overall survival (OS)","OS defined as the number of months from the date of first study treatment administration to the date of death, irrespective of cause",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":30,"timePerspective":30,"maskingInfo":61},"NA","SEQUENTIAL","Dose-escalation and dose optimization","TREATMENT",{"masking":62,"maskingDescription":30,"whoMasked":30},"NONE","This is a Phase 1\u002F1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations.\n\nThis study consists of the following 4 parts:\n\n* Part 1 (Monotherapy Dose Escalation)\n* Part 2 (Dose Optimization)\n* Part 3 (Dose Expansion)\n* Part 4 (Combination Cohorts)\n\nPart 1 will enroll participants with a confirmed, relapsed\u002Frefractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)\u002Frecommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened to enroll tumor-specific cohorts utilizing a Simon 2-Stage Minimax Design to evaluate IAM1363 at the selected dose(s).\n\nPart 4 will enroll 4 cohorts of participants who will receive IAM1363 in combination with other anti-cancer agents.",[65],{"label":66,"type":67,"description":68,"interventionNames":69},"IAM1363 Monotherapy or Combination Therapy","EXPERIMENTAL","Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.",[70],"Drug: IAM1363",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":30},"DRUG","IAM1363","IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR IAM1363 in combination with pembrolizumab +\u002F- carboplatin and pemetrexed",[66],[78],{"name":79,"affiliation":5,"role":80},"Iambic Therapeutics, Inc., Senior Medical Director","STUDY_DIRECTOR",[82],{"name":79,"role":83,"phone":84,"phoneExt":30,"email":85},"CONTACT","619-330-5499","ClinicalTrials@Iambic.ai",[87,101,110,120,130,139,149,159,165,175,184,193,203,212,222,232,241,251,261,267,277,287,297,303,313,322,331,344,354,364,375,384,393,404,413,419,430,439,445,454,465,475,481,487,493,504,513,519,528,537,546,557,566],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":30},"UCSD Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-117.2742,32.84727,{"lat":99,"lon":98},{"facility":102,"status":89,"city":103,"state":91,"zip":104,"country":93,"countryCode":94,"cosmosGeoPoint":105,"geoPoint":109,"contacts":30},"USC Norris Comprehensive Cancer Center","Los Angeles","90089",{"type":96,"coordinates":106},[107,108],-118.24368,34.05223,{"lat":108,"lon":107},{"facility":111,"status":89,"city":112,"state":113,"zip":114,"country":93,"countryCode":94,"cosmosGeoPoint":115,"geoPoint":119,"contacts":30},"University of Colorado Cancer Center","Aurora","Colorado","80045",{"type":96,"coordinates":116},[117,118],-104.83192,39.72943,{"lat":118,"lon":117},{"facility":121,"status":89,"city":122,"state":123,"zip":124,"country":93,"countryCode":94,"cosmosGeoPoint":125,"geoPoint":129,"contacts":30},"University of Miami","Miami","Florida","33136",{"type":96,"coordinates":126},[127,128],-80.19366,25.77427,{"lat":128,"lon":127},{"facility":131,"status":89,"city":132,"state":123,"zip":133,"country":93,"countryCode":94,"cosmosGeoPoint":134,"geoPoint":138,"contacts":30},"Comprehensive Hematology Oncology","St. Petersburg","33709",{"type":96,"coordinates":135},[136,137],-82.67927,27.77086,{"lat":137,"lon":136},{"facility":140,"status":89,"city":141,"state":142,"zip":143,"country":93,"countryCode":94,"cosmosGeoPoint":144,"geoPoint":148,"contacts":30},"University of Chicago","Chicago","Illinois","60637",{"type":96,"coordinates":145},[146,147],-87.65005,41.85003,{"lat":147,"lon":146},{"facility":150,"status":89,"city":151,"state":152,"zip":153,"country":93,"countryCode":94,"cosmosGeoPoint":154,"geoPoint":158,"contacts":30},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":96,"coordinates":155},[156,157],-71.05977,42.35843,{"lat":157,"lon":156},{"facility":160,"status":89,"city":151,"state":152,"zip":161,"country":93,"countryCode":94,"cosmosGeoPoint":162,"geoPoint":164,"contacts":30},"Dana Farber Cancer Institute","02215",{"type":96,"coordinates":163},[156,157],{"lat":157,"lon":156},{"facility":166,"status":89,"city":167,"state":168,"zip":169,"country":93,"countryCode":94,"cosmosGeoPoint":170,"geoPoint":174,"contacts":30},"University of Michigan","Ann Arbor","Michigan","48109",{"type":96,"coordinates":171},[172,173],-83.74088,42.27756,{"lat":173,"lon":172},{"facility":176,"status":89,"city":177,"state":168,"zip":178,"country":93,"countryCode":94,"cosmosGeoPoint":179,"geoPoint":183,"contacts":30},"Henry Ford Cancer Institute","Detroit","48202",{"type":96,"coordinates":180},[181,182],-83.04575,42.33143,{"lat":182,"lon":181},{"facility":185,"status":89,"city":186,"state":168,"zip":187,"country":93,"countryCode":94,"cosmosGeoPoint":188,"geoPoint":192,"contacts":30},"START - Midwest Cancer Research Center","Grand Rapids","49546",{"type":96,"coordinates":189},[190,191],-85.66809,42.96336,{"lat":191,"lon":190},{"facility":194,"status":89,"city":195,"state":196,"zip":197,"country":93,"countryCode":94,"cosmosGeoPoint":198,"geoPoint":202,"contacts":30},"Saint Luke's Cancer Institute","Kansas City","Missouri","64111",{"type":96,"coordinates":199},[200,201],-94.57857,39.09973,{"lat":201,"lon":200},{"facility":204,"status":89,"city":205,"state":196,"zip":206,"country":93,"countryCode":94,"cosmosGeoPoint":207,"geoPoint":211,"contacts":30},"Washington University School of Medicine","St Louis","63110",{"type":96,"coordinates":208},[209,210],-90.19789,38.62727,{"lat":210,"lon":209},{"facility":213,"status":89,"city":214,"state":215,"zip":216,"country":93,"countryCode":94,"cosmosGeoPoint":217,"geoPoint":221,"contacts":30},"Dartmouth Hitchcock Medical","Lebanon","New Hampshire","03756",{"type":96,"coordinates":218},[219,220],-72.25176,43.64229,{"lat":220,"lon":219},{"facility":223,"status":89,"city":224,"state":225,"zip":226,"country":93,"countryCode":94,"cosmosGeoPoint":227,"geoPoint":231,"contacts":30},"Rutgers Cancer Institute","New Brunswick","New Jersey","08901",{"type":96,"coordinates":228},[229,230],-74.45182,40.48622,{"lat":230,"lon":229},{"facility":233,"status":89,"city":234,"state":234,"zip":235,"country":93,"countryCode":94,"cosmosGeoPoint":236,"geoPoint":240,"contacts":30},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":96,"coordinates":237},[238,239],-74.00597,40.71427,{"lat":239,"lon":238},{"facility":242,"status":89,"city":243,"state":244,"zip":245,"country":93,"countryCode":94,"cosmosGeoPoint":246,"geoPoint":250,"contacts":30},"Duke Cancer Institute","Durham","North Carolina","27710",{"type":96,"coordinates":247},[248,249],-78.89862,35.99403,{"lat":249,"lon":248},{"facility":252,"status":89,"city":253,"state":254,"zip":255,"country":93,"countryCode":94,"cosmosGeoPoint":256,"geoPoint":260,"contacts":30},"University Hospital Cleveland Medical Center","Cleveland","Ohio","44106",{"type":96,"coordinates":257},[258,259],-81.69541,41.4995,{"lat":259,"lon":258},{"facility":262,"status":89,"city":253,"state":254,"zip":263,"country":93,"countryCode":94,"cosmosGeoPoint":264,"geoPoint":266,"contacts":30},"Cleveland Clinic","44195",{"type":96,"coordinates":265},[258,259],{"lat":259,"lon":258},{"facility":268,"status":89,"city":269,"state":270,"zip":271,"country":93,"countryCode":94,"cosmosGeoPoint":272,"geoPoint":276,"contacts":30},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":96,"coordinates":273},[274,275],-97.51643,35.46756,{"lat":275,"lon":274},{"facility":278,"status":89,"city":279,"state":280,"zip":281,"country":93,"countryCode":94,"cosmosGeoPoint":282,"geoPoint":286,"contacts":30},"Providence Cancer Institute","Portland","Oregon","97213",{"type":96,"coordinates":283},[284,285],-122.67621,45.52345,{"lat":285,"lon":284},{"facility":288,"status":89,"city":289,"state":290,"zip":291,"country":93,"countryCode":94,"cosmosGeoPoint":292,"geoPoint":296,"contacts":30},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":96,"coordinates":293},[294,295],-86.78444,36.16589,{"lat":295,"lon":294},{"facility":298,"status":89,"city":289,"state":290,"zip":299,"country":93,"countryCode":94,"cosmosGeoPoint":300,"geoPoint":302,"contacts":30},"Vanderbilt Ingram Cancer Center","37232",{"type":96,"coordinates":301},[294,295],{"lat":295,"lon":294},{"facility":304,"status":89,"city":305,"state":306,"zip":307,"country":93,"countryCode":94,"cosmosGeoPoint":308,"geoPoint":312,"contacts":30},"NEXT Oncology - Austin","Austin","Texas","78758",{"type":96,"coordinates":309},[310,311],-97.74306,30.26715,{"lat":311,"lon":310},{"facility":314,"status":89,"city":315,"state":306,"zip":316,"country":93,"countryCode":94,"cosmosGeoPoint":317,"geoPoint":321,"contacts":30},"Mary Crowley Cancer Research","Dallas","75230",{"type":96,"coordinates":318},[319,320],-96.80667,32.78306,{"lat":320,"lon":319},{"facility":323,"status":89,"city":324,"state":306,"zip":325,"country":93,"countryCode":94,"cosmosGeoPoint":326,"geoPoint":330,"contacts":30},"MD Anderson Cancer Center - University of Texas","Houston","77030",{"type":96,"coordinates":327},[328,329],-95.36327,29.76328,{"lat":329,"lon":328},{"facility":332,"status":89,"city":333,"state":334,"zip":335,"country":93,"countryCode":94,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"START Mountain Region","West Valley City","Utah","84119",{"type":96,"coordinates":337},[338,339],-112.00105,40.69161,{"lat":339,"lon":338},[342],{"name":30,"role":83,"phone":30,"phoneExt":30,"email":343},"hopeteam@startresearch.com",{"facility":345,"status":89,"city":346,"state":347,"zip":348,"country":93,"countryCode":94,"cosmosGeoPoint":349,"geoPoint":353,"contacts":30},"NEXT Oncology - Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":96,"coordinates":350},[351,352],-77.30637,38.84622,{"lat":352,"lon":351},{"facility":355,"status":89,"city":356,"state":357,"zip":358,"country":93,"countryCode":94,"cosmosGeoPoint":359,"geoPoint":363,"contacts":30},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":96,"coordinates":360},[361,362],-122.33207,47.60621,{"lat":362,"lon":361},{"facility":365,"status":89,"city":366,"state":30,"zip":367,"country":368,"countryCode":369,"cosmosGeoPoint":370,"geoPoint":374,"contacts":30},"Centre Georges François Leclerc","Dijon","21079","France","FR",{"type":96,"coordinates":371},[372,373],5.01391,47.31344,{"lat":373,"lon":372},{"facility":376,"status":89,"city":377,"state":30,"zip":378,"country":368,"countryCode":369,"cosmosGeoPoint":379,"geoPoint":383,"contacts":30},"Institut de Cancerologie de l'Ouest","Saint-Herblain","44805",{"type":96,"coordinates":380},[381,382],-1.651,47.21154,{"lat":382,"lon":381},{"facility":385,"status":89,"city":386,"state":30,"zip":387,"country":368,"countryCode":369,"cosmosGeoPoint":388,"geoPoint":392,"contacts":30},"Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud \"","Toulouse","31059",{"type":96,"coordinates":389},[390,391],1.44367,43.60426,{"lat":391,"lon":390},{"facility":394,"status":89,"city":395,"state":395,"zip":396,"country":397,"countryCode":398,"cosmosGeoPoint":399,"geoPoint":403,"contacts":30},"The START center Dublin","Dublin","D07 R2WY","Ireland","IE",{"type":96,"coordinates":400},[401,402],-6.24889,53.33306,{"lat":402,"lon":401},{"facility":405,"status":89,"city":406,"state":30,"zip":407,"country":397,"countryCode":398,"cosmosGeoPoint":408,"geoPoint":412,"contacts":30},"Cork University Hospital, Wilton","Cork","T12DC4A",{"type":96,"coordinates":409},[410,411],-8.47061,51.89797,{"lat":411,"lon":410},{"facility":414,"status":89,"city":395,"state":30,"zip":415,"country":397,"countryCode":398,"cosmosGeoPoint":416,"geoPoint":418,"contacts":30},"St. Vincent's University Hospital","D04 T6F4",{"type":96,"coordinates":417},[401,402],{"lat":402,"lon":401},{"facility":420,"status":89,"city":421,"state":30,"zip":422,"country":423,"countryCode":424,"cosmosGeoPoint":425,"geoPoint":429,"contacts":30},"Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3","Florence","50134","Italy","IT",{"type":96,"coordinates":426},[427,428],11.24626,43.77925,{"lat":428,"lon":427},{"facility":431,"status":89,"city":432,"state":30,"zip":433,"country":423,"countryCode":424,"cosmosGeoPoint":434,"geoPoint":438,"contacts":30},"Istituto Europeo di Oncologia (IEO)","Milan","20141",{"type":96,"coordinates":435},[436,437],12.59836,42.78235,{"lat":437,"lon":436},{"facility":440,"status":89,"city":432,"state":30,"zip":441,"country":423,"countryCode":424,"cosmosGeoPoint":442,"geoPoint":444,"contacts":30},"Grande Ospedale Metropolitano Niguarda","20162",{"type":96,"coordinates":443},[436,437],{"lat":437,"lon":436},{"facility":446,"status":89,"city":447,"state":30,"zip":448,"country":423,"countryCode":424,"cosmosGeoPoint":449,"geoPoint":453,"contacts":30},"Azienda Ospedaliera Universitaria Luigi Vanvitelli","Naples","80131",{"type":96,"coordinates":450},[451,452],14.26811,40.85216,{"lat":452,"lon":451},{"facility":455,"status":89,"city":456,"state":30,"zip":457,"country":458,"countryCode":459,"cosmosGeoPoint":460,"geoPoint":464,"contacts":30},"Netherlands Cancer Institute-Antoni van Leeuwenhoek","Amsterdam","1066CX","Netherlands","NL",{"type":96,"coordinates":461},[462,463],4.88969,52.37403,{"lat":463,"lon":462},{"facility":466,"status":89,"city":467,"state":30,"zip":468,"country":469,"countryCode":30,"cosmosGeoPoint":470,"geoPoint":474,"contacts":30},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":96,"coordinates":471},[472,473],126.9784,37.566,{"lat":473,"lon":472},{"facility":476,"status":89,"city":467,"state":30,"zip":477,"country":469,"countryCode":30,"cosmosGeoPoint":478,"geoPoint":480,"contacts":30},"Severance Hospital - Yonsei Cancer Center","03722",{"type":96,"coordinates":479},[472,473],{"lat":473,"lon":472},{"facility":482,"status":89,"city":467,"state":30,"zip":483,"country":469,"countryCode":30,"cosmosGeoPoint":484,"geoPoint":486,"contacts":30},"Asan Medical Center","05505",{"type":96,"coordinates":485},[472,473],{"lat":473,"lon":472},{"facility":488,"status":89,"city":467,"state":30,"zip":489,"country":469,"countryCode":30,"cosmosGeoPoint":490,"geoPoint":492,"contacts":30},"Samsung Medical Center","06351",{"type":96,"coordinates":491},[472,473],{"lat":473,"lon":472},{"facility":494,"status":89,"city":495,"state":30,"zip":496,"country":497,"countryCode":498,"cosmosGeoPoint":499,"geoPoint":503,"contacts":30},"Hospital Universitario Vall dHebron","Barcelona","08035","Spain","ES",{"type":96,"coordinates":500},[501,502],2.15899,41.38879,{"lat":502,"lon":501},{"facility":505,"status":89,"city":506,"state":30,"zip":507,"country":497,"countryCode":498,"cosmosGeoPoint":508,"geoPoint":512,"contacts":30},"Hospital Universitario 12 de Octubre","Madrid","28041",{"type":96,"coordinates":509},[510,511],-3.70256,40.4165,{"lat":511,"lon":510},{"facility":514,"status":89,"city":506,"state":30,"zip":515,"country":497,"countryCode":498,"cosmosGeoPoint":516,"geoPoint":518,"contacts":30},"START Madrid CIOCC, Hospital Universitario HM Sanchinarro","28050",{"type":96,"coordinates":517},[510,511],{"lat":511,"lon":510},{"facility":520,"status":89,"city":521,"state":30,"zip":522,"country":497,"countryCode":498,"cosmosGeoPoint":523,"geoPoint":527,"contacts":30},"Hospital Universitario Regional Málaga","Málaga","29011",{"type":96,"coordinates":524},[525,526],-4.42034,36.72016,{"lat":526,"lon":525},{"facility":529,"status":89,"city":530,"state":30,"zip":531,"country":497,"countryCode":498,"cosmosGeoPoint":532,"geoPoint":536,"contacts":30},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":96,"coordinates":533},[534,535],-5.97317,37.38283,{"lat":535,"lon":534},{"facility":538,"status":89,"city":539,"state":30,"zip":540,"country":497,"countryCode":498,"cosmosGeoPoint":541,"geoPoint":545,"contacts":30},"Hospital Clinico Universitario de Valencia (INCLIVA)","Valencia","46010",{"type":96,"coordinates":542},[543,544],-0.37966,39.47391,{"lat":544,"lon":543},{"facility":547,"status":89,"city":548,"state":30,"zip":549,"country":550,"countryCode":551,"cosmosGeoPoint":552,"geoPoint":556,"contacts":30},"Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)\u002FChelsea)","Chelsea","SW3 6JJ","United Kingdom","UK",{"type":96,"coordinates":553},[554,555],-0.16936,51.48755,{"lat":555,"lon":554},{"facility":558,"status":89,"city":559,"state":30,"zip":560,"country":550,"countryCode":551,"cosmosGeoPoint":561,"geoPoint":565,"contacts":30},"Oxford University Hospitals NHS Foundation Trust Churchill Hospital","Oxford","OX3 7LE",{"type":96,"coordinates":562},[563,564],-1.25596,51.75222,{"lat":564,"lon":563},{"facility":567,"status":89,"city":568,"state":30,"zip":569,"country":550,"countryCode":551,"cosmosGeoPoint":570,"geoPoint":574,"contacts":30},"Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)\u002FSutton","Sutton","SM2 5PT",{"type":96,"coordinates":571},[572,573],-0.2,51.35,{"lat":573,"lon":572},{"type":576,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595",false,"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","ALL","18 Years",{"count":587,"type":588},383,"ESTIMATED","INTERVENTIONAL",[591],"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.",[594,595,596,597,598,599,600,601,602,603,604,605,606],"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 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[608,609,610,611,612,613,614,615,616,617,595,618],"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","2026-09-04",{"date":621,"type":622},"2026-09-09","ACTUAL",{"date":624,"type":622},"2024-03-25",{"date":626,"type":588},"2028-12",{"name":5,"class":6},53]