[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634506":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":200,"collaborators":32,"id":202,"slug":203,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":32,"eligibilityCriteria":208,"healthyVolunteers":204,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":32,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"IDEAYA Biosciences","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy Dose Escalation (Part 1A)","EXPERIMENTAL","Participants with the appropriate tumor types will be treated with escalating doses of IDE574",[13],"Drug: IDE574",{"label":15,"type":10,"description":16,"interventionNames":17},"Monotherapy Dose Expansion (Part 1B)","Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant","Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant",[13,22],"Drug: Fulvestrant injection",{"label":24,"type":10,"description":25,"interventionNames":26},"Combination Dose Expansion (Part 2B)","Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant",[13,22],[28,33],{"type":29,"name":30,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","IDE574",[19,24,9,15],null,{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Fulvestrant injection","Fulvestrant Injection",[19,24],[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"IDEAYA Clinical Trials","CONTACT","+1-855-433-224","IDEAYAClinicalTrials@ideayabio.com",[44,63,78,92,107,121,134,148,162,171,185],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Florida Clinical Trials Group","RECRUITING","Plantation","Florida","33322","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-80.23184,26.13421,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":32,"email":62},"Harshad Amin","954-915-9991","harshamin@floridactg.com",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"START Astera, LLC","East Brunswick","New Jersey","08816",{"type":53,"coordinates":69},[70,71],-74.41598,40.42788,{"lat":71,"lon":70},[74],{"name":75,"role":40,"phone":76,"phoneExt":32,"email":77},"Bruno S Fang","732-426-4750","info@startresearch.com",{"facility":79,"status":46,"city":80,"state":81,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"START New York Long Island, LLC","Lake Success","New York","11042",{"type":53,"coordinates":84},[85,86],-73.71763,40.77066,{"lat":86,"lon":85},[89],{"name":90,"role":40,"phone":91,"phoneExt":32,"email":77},"Geralinde O'Sullivan Coyne","363-207-5160",{"facility":93,"status":46,"city":94,"state":95,"zip":96,"country":50,"countryCode":51,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"NEXT Texas LLC - 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Houston","Houston","77054",{"type":53,"coordinates":139},[140,141],-95.36327,29.76328,{"lat":141,"lon":140},[144],{"name":145,"role":40,"phone":146,"phoneExt":32,"email":147},"Jennifer Segar","832-384-7900","jsegar@nextoncology.com",{"facility":149,"status":46,"city":150,"state":95,"zip":151,"country":50,"countryCode":51,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"NEXT Texas LLC - San Antonio","San Antonio","78229",{"type":53,"coordinates":153},[154,155],-98.49363,29.42412,{"lat":155,"lon":154},[158],{"name":159,"role":40,"phone":160,"phoneExt":32,"email":161},"David Sommerhalder","210-580-9500","dsommerhalder@nextoncology.com",{"facility":163,"status":46,"city":150,"state":95,"zip":151,"country":50,"countryCode":51,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"Start San Antonio, LLC",{"type":53,"coordinates":165},[154,155],{"lat":155,"lon":154},[168],{"name":169,"role":40,"phone":170,"phoneExt":32,"email":77},"Amita Patnaik","2105935250",{"facility":172,"status":46,"city":173,"state":174,"zip":175,"country":50,"countryCode":51,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"START Mountain Region, LLC","West Valley City","Utah","84119",{"type":53,"coordinates":177},[178,179],-112.00105,40.69161,{"lat":179,"lon":178},[182],{"name":183,"role":40,"phone":184,"phoneExt":32,"email":77},"William B McKean","1 (801) 907-4750",{"facility":186,"status":46,"city":187,"state":188,"zip":189,"country":50,"countryCode":51,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"NEXT Virginia","Fairfax","Virginia","22031",{"type":53,"coordinates":191},[192,193],-77.30637,38.84622,{"lat":193,"lon":192},[196],{"name":197,"role":40,"phone":198,"phoneExt":32,"email":199},"Mohamad A Salkeni","703-783-4510","msalkeni@nextoncology.com",{"type":201,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100634506","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-ide574-therapy-in-adult-participants-with-advanced-solid-tumors-100634506",false,"NCT07540572","A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors","An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer","Inclusion Criteria:\n\nArchival Tissue sample for testing\n\n* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.\n* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor\n* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)\n* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.\n* Have adequate bone marrow, renal and liver function.\n* Life expectancy of \\>3 months\n* Able to safely administer and retain orally administered study treatment\n* Able to comply with contraceptive\u002Fbarrier requirements\n\nKey Exclusion Criteria:\n\n* Known symptomatic brain metastases or leptomeningeal metastasis\n* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.\n* Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.\n* Have active liver or biliary disease.\n* Have active, uncontrolled bacterial, fungal, or viral infection\n* Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose\n* If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1\n* Prior irradiation to \\>25% of the bone marrow.\n* Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)","ALL","18 Years","99 Years",{"count":213,"type":214},160,"ESTIMATED","INTERVENTIONAL",[217],"PHASE1","IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.\n\nThe purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.",[220,221,222,223],"ER+, HER 2- Breast Cancer","Non-small Cell Lung Cancer (NSCLC)","Castration-resistant Prostate Cancer (CRPC)","Microsatellite Stable (MSS) Colorectal Carcinoma",[220,221,222,223,225,226],"KAT6A\u002FB","KAT7","2026-06-12",{"date":229,"type":230},"2026-06-16","ACTUAL",{"date":232,"type":230},"2026-03-17",{"date":234,"type":214},"2030-06-30",{"name":5,"class":6},11]