[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535398":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":42,"centralContacts":47,"locations":53,"responsibleParty":197,"collaborators":37,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":37,"eligibilityCriteria":205,"healthyVolunteers":201,"sex":206,"minAge":207,"maxAge":37,"enrollmentInfo":208,"targetDuration":37,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":37,"overallStatus":56,"whyStopped":37,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Dose Escalation Cohorts Ranging in Dose","EXPERIMENTAL","Participants with advanced solid tumors with or without Hippo pathway mutations will receive SW-682 tablets administered orally in continuous 28-day cycles. SW-682 dosage and frequency of administration will vary by cohort.",[13],"Drug: SW-682",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2 Dose Expansion Cohort 1","Participants with mesothelioma with or without NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 2 Dose Expansion Cohort 2","Participants with advanced solid tumors with NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2 Dose Expansion Cohort 3","Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part 2 Dose Expansion Cohort 4","Participants will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data, with appropriate combination therapy, identified based on Part 1 data.",[13,30],"Drug: Combination Therapy",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","SW-682","SW-682 tablet administered orally",[15,19,23,27,9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Combination Therapy","Appropriate combination therapy",[27],[43],{"name":44,"affiliation":45,"role":46},"Medical Responsible","SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany","STUDY_DIRECTOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":37,"email":52},"US Medical Information","CONTACT","888-275-7376","eMediUSA@emdserono.com",[54,79,96,110,124,143,162,178],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"HonorHealth Research Institute","RECRUITING","Scottsdale","Arizona","85258","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-111.89903,33.50921,{"lat":66,"lon":65},[69,73,76],{"name":70,"role":50,"phone":71,"phoneExt":37,"email":72},"Nurse Navigation Team","480-323-1791","elisejohnson@honorhealth.com",{"name":70,"role":50,"phone":74,"phoneExt":37,"email":75},"833-354-6667","clinicaltrials@honorhealth.com",{"name":77,"role":78,"phone":37,"phoneExt":37,"email":37},"Muhammad R Khawaja, MD","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":56,"city":81,"state":82,"zip":83,"country":60,"countryCode":61,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"UC San Diego Moores Cancer Center","La Jolla","California","92093",{"type":63,"coordinates":85},[86,87],-117.2742,32.84727,{"lat":87,"lon":86},[90,94],{"name":91,"role":50,"phone":92,"phoneExt":37,"email":93},"Katherine Velasco","858-822-5677","kcvelasco@health.ucsd.edu",{"name":95,"role":78,"phone":37,"phoneExt":37,"email":37},"Sandip Patel, MD",{"facility":97,"status":56,"city":98,"state":82,"zip":99,"country":60,"countryCode":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"USC Norris Comprehensive Cancer Center and Hospital","Los Angeles","90033",{"type":63,"coordinates":101},[102,103],-118.24368,34.05223,{"lat":103,"lon":102},[106,109],{"name":107,"role":50,"phone":37,"phoneExt":37,"email":108},"Diana Hanna, MD","diana.hanna@med.usc.edu",{"name":107,"role":78,"phone":37,"phoneExt":37,"email":37},{"facility":111,"status":56,"city":98,"state":82,"zip":112,"country":60,"countryCode":61,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"UCLA Hematology-Oncology - Santa Monica","90095",{"type":63,"coordinates":114},[102,103],{"lat":103,"lon":102},[117,122],{"name":118,"role":50,"phone":119,"phoneExt":120,"email":121},"Jacqueline Banuelos Murillo","310-633-8400","16068","jbanuelosillo@mednet.ucla.edu",{"name":123,"role":78,"phone":37,"phoneExt":37,"email":37},"Arun S Singh, MD",{"facility":125,"status":56,"city":126,"state":127,"zip":128,"country":60,"countryCode":61,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"University Hospital of Cleveland","Cleveland","Ohio","44106",{"type":63,"coordinates":130},[131,132],-81.69541,41.4995,{"lat":132,"lon":131},[135,139,142],{"name":136,"role":50,"phone":137,"phoneExt":37,"email":138},"Afshin Dowlati, MD","216-844-3951","afshin.dowlati@uhhospitals.org",{"name":140,"role":50,"phone":37,"phoneExt":37,"email":141},"Amanda Pawlus","amanda.pawlus@uhhospitals.org",{"name":136,"role":78,"phone":37,"phoneExt":37,"email":37},{"facility":144,"status":56,"city":145,"state":146,"zip":147,"country":60,"countryCode":61,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Oregon Health and Science University, Knight Cancer Institute - Marquam Hill","Portland","Oregon","97239",{"type":63,"coordinates":149},[150,151],-122.67621,45.52345,{"lat":151,"lon":150},[154,157,160],{"name":37,"role":50,"phone":155,"phoneExt":37,"email":156},"503-494-1080","trials@ohsu.edu",{"name":158,"role":50,"phone":37,"phoneExt":37,"email":159},"Grace PArk","parkgr@ohsu.edu",{"name":161,"role":78,"phone":37,"phoneExt":37,"email":37},"Shivaani Kummar",{"facility":163,"status":56,"city":164,"state":165,"zip":166,"country":60,"countryCode":61,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Mary Crowley Research Center US Oncology","Dallas","Texas","75230",{"type":63,"coordinates":168},[169,170],-96.80667,32.78306,{"lat":170,"lon":169},[173,177],{"name":174,"role":50,"phone":175,"phoneExt":37,"email":176},"Douglas Orr, MD","972-566-3000","referral@marycrowley.org",{"name":174,"role":78,"phone":37,"phoneExt":37,"email":37},{"facility":179,"status":56,"city":180,"state":165,"zip":181,"country":60,"countryCode":61,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"U.T. MD Anderson Cancer Center","Houston","77030",{"type":63,"coordinates":183},[184,185],-95.36327,29.76328,{"lat":185,"lon":184},[188,192,195],{"name":189,"role":50,"phone":190,"phoneExt":37,"email":191},"Ileana Gutierrez","713-563-2158","ILGutierrez@mdanderson.org",{"name":193,"role":50,"phone":37,"phoneExt":37,"email":194},"Minh Nguyen","mqnguyen2@mdanderson.org",{"name":196,"role":78,"phone":37,"phoneExt":37,"email":37},"Timothy Yap, MD",{"type":198,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100535398","phase-1-sw-682-in-advanced-solid-tumors-100535398",false,"NCT06251310","SW-682 in Advanced Solid Tumors","A Phase 1a\u002F1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations","Key Inclusion Criteria:\n\n* Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for which there is no treatment available or prior SOC therapy was not tolerated and for which there is no further SOC treatment available\n* Part 1: must have one of the following:\n\n  * Mesothelioma with or without NF2 mutations\n  * Advanced solid tumors with NF2 mutations\n  * Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1\u002F2, YAP fusions; WWTR1-CAMTA1 in EHE).\n* Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:\n\n  * Cohort 1: Participants with mesothelioma with or without NF2 mutations\n  * Cohort 2: Participants with advanced solid tumors with NF2 mutations\n  * Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation\n  * Cohort 4: SW-682 with appropriate combination therapy.\n* In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay\n* Must have archival tumor tissue or agree to a fresh tumor biopsy at screening\n* Measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1\n* Adequate bone marrow, kidney, hepatic, and coagulation function\n\nKey Exclusion Criteria:\n\n* Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression\n* Clinically significant cardiac disease or abnormal cardiac parameters\n* Preexistence or inheritance of a familial renal syndrome\n* Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval\n* Concomitant medicines that are known strong\u002Fmoderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and\u002For CYP1A2 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and\u002For CYP2B6 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2\n* Clinically significant active infection (bacterial, fungal, or viral)","ALL","18 Years",{"count":209,"type":210},186,"ESTIMATED","INTERVENTIONAL",[213],"PHASE1","This is a first-in-human (FIH), Phase 1a\u002F1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.",[216,217],"Advanced Solid Tumor","Mesothelioma, Malignant","2026-06-17",{"date":220,"type":221},"2026-06-22","ACTUAL",{"date":223,"type":221},"2024-07-31",{"date":225,"type":210},"2027-01-18",{"name":45,"class":6},8]