[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06789913":3,"trial-entities:NCT06789913":612,"trial-summary:NCT06789913":622},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":53,"secondary_outcomes":62,"sex":86,"minimum_age":87,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":88,"std_ages":100,"locations":104,"central_contacts":604,"overall_officials":609,"references":610,"see_also_links":611},"NCT06789913","RLY-2608-201","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation","RECRUITING","2031-10","2026-06","2026-08-25","2025-06-13","Relay Therapeutics, Inc.","INDUSTRY",false,"This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.",null,[19,20,21,22,23,24,25,26],"PIK3CA-Related Overgrowth Spectrum (PROS)","Lymphatic Malformations","Vascular Malformations","PIK3CA Mutation","CLOVES Syndrome","Klippel Trenaunay Syndrome","Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)","Vascular Anomalies",[],"INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},277,"ESTIMATED",[36,48],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","RLY-2608","RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.",[41,42,43,44,45,46,47],"Part 1, Group 1","Part 1, Group 2","Part 1, Group 3","Part 2, Group 1","Part 2, Group 2","Part 2, Group 3","Part 3, Arm 1",{"type":37,"name":49,"description":50,"armGroupLabels":51},"Placebo","RLY-2608 matched-placebo",[52],"Part 3, Arm 2",[54,57,59],{"measure":55,"timeFrame":56},"Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3","Cycle 1 of treatment and at the end of every cycle until study discontinuation",{"measure":58,"timeFrame":56},"Parts 1 and 2: Occurrence\u002Ffrequency of Adverse Events (AEs), changes in vital signs, ECGs, and safety laboratory tests and their relationship to the study drugs (safety and tolerability).",{"measure":60,"timeFrame":61},"Part 3: Percentage of participants with volumetric Response.","Baseline, Week 24",[63,65,68,71,74,77,80,82,84],{"measure":64,"timeFrame":61},"Part 1 and 2: Percent change from baseline in lesion volume",{"measure":66,"timeFrame":67},"Part 1 and 2: Duration of response, defined as the time of first documented response to the date of first documented disease progression or death due to any cause","Approximately every 3 months for approximately the first year, and then every 6 months during treatment",{"measure":69,"timeFrame":70},"Part 1 and 2: Percentage of participants with volumetric response","Baseline, week 12, week 24",{"measure":72,"timeFrame":73},"Part 1 and 2: Plasma concentrations and PK parameters of RLY-2608","Approximately every 2 weeks in Cycle 1, then again at Cycles 2, 4 and Cycle 7 depending on the participant's group",{"measure":75,"timeFrame":76},"Part 1 and 2: PIK3CA mutational status in lesional fluid and\u002For tissue","Prior to enrollment",{"measure":78,"timeFrame":79},"Part 3: Percentage of participants with improvement compared to baseline based on PGI-S, PGI-C and IGIC","Approximately once a month until end of treatment",{"measure":81,"timeFrame":79},"Part 3: Change from baseline by age-appropriate PROMIS Profile",{"measure":83,"timeFrame":79},"Part 3: Change from baseline in EQ-5D, EQ-5D-Y, or EQ-5D-Y Proxy",{"measure":85,"timeFrame":67},"Part 3: Percent change from baseline in lesion volume","ALL","2 Years",{"inclusion":89,"exclusion":94,"raw_text":99},[90,91,92,93],"The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.","One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and\u002For cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.","Lansky (\\\u003C16 yo) or Karnofsky (≥16 yo) performance status of ≥50.","Agree to provide archived lesional fluid and\u002For tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.",[95,96,97,98],"Known hypersensitivity to RLY-2608.","Any factors that increase the risk of QTc prolongation or risk of arrhythmic events","Clinically significant, uncontrolled cardiovascular disease","Received disease-directed therapy prior to the first dose of study drug:","Key Inclusion Criteria:\n\n* The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.\n* One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and\u002For cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.\n* Lansky (\\\u003C16 yo) or Karnofsky (≥16 yo) performance status of ≥50.\n* Agree to provide archived lesional fluid and\u002For tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to RLY-2608.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Clinically significant, uncontrolled cardiovascular disease\n* Received disease-directed therapy prior to the first dose of study drug:\n\n  1. Systemic therapy or antibody within 5 half-lives of the therapy.\n  2. Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.",[101,102,103],"CHILD","ADULT","OLDER_ADULT",[105,120,133,146,158,173,186,203,216,229,242,255,267,280,292,299,312,325,337,351,364,377,389,403,416,429,441,454,470,478,490,503,516,528,536,547,559,572,583,596],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":117},"Phoenix Children's Hospital","Phoenix","Arizona","85016","United States",[112],{"name":113,"role":114,"phone":115,"email":116},"Chris Oless","CONTACT","602-933-0188","dg_EDDT@phoenixchildrens.com",{"lat":118,"lon":119},33.44838,-112.07404,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":110,"contacts":125,"geoPoint":130},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",[126],{"name":127,"role":114,"phone":128,"email":129},"D'Ann Pierce","501-364-4440","PierceCarolD@uams.edu",{"lat":131,"lon":132},34.74648,-92.28959,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":110,"contacts":138,"geoPoint":143},"University of California, Los Angeles","Los Angeles","California","90095",[139],{"name":140,"role":114,"phone":141,"email":142},"Brianna Connors","310-825-6708","bconnors@mednet.ucla.edu",{"lat":144,"lon":145},34.05223,-118.24368,{"facility":147,"status":8,"city":148,"state":136,"zip":149,"country":110,"contacts":150,"geoPoint":155},"Stanford University","Palo Alto","94304",[151],{"name":152,"role":114,"phone":153,"email":154},"Ramrada Lekwuttikarn","650-313-8207","ramrada1@stanford.edu",{"lat":156,"lon":157},37.44188,-122.14302,{"facility":159,"status":8,"city":160,"state":136,"zip":161,"country":110,"contacts":162,"geoPoint":170},"University of California, San Francisco","San Francisco","94158",[163,166],{"name":164,"role":114,"email":165},"Beth Winger, MD","Beth.Winger@ucsf.edu",{"name":167,"role":114,"phone":168,"email":169},"Audrey Hernando","(415) 502-2425","Audrey.Hernando@ucsf.edu",{"lat":171,"lon":172},37.77493,-122.41942,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":110,"contacts":178,"geoPoint":183},"Children's Hospital Colorado","Aurora","Colorado","80045",[179],{"name":180,"role":114,"phone":181,"email":182},"Taizo Nakano, MD","720-777-6663","taizo.nakano@childrenscolorado.org",{"lat":184,"lon":185},39.72943,-104.83192,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":110,"contacts":191,"geoPoint":200},"Children's Hospital of Atlanta","Atlanta","Georgia","30329",[192,196],{"name":193,"role":114,"phone":194,"email":195},"Lauren Rogers","404-785-2727","Lauren.Rogers@choa.org",{"name":197,"role":114,"phone":198,"email":199},"Gabrielle Dean","404-785-8700","Gabrielle.Dean@choa.org",{"lat":201,"lon":202},33.749,-84.38798,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":110,"contacts":208,"geoPoint":213},"Riley Children's Hospital","Indianapolis","Indiana","46202",[209],{"name":210,"role":114,"phone":211,"email":212},"Riley PHOS Research Team","317-948-8540","rileyphosresearchteam@iuhealth.org",{"lat":214,"lon":215},39.76838,-86.15804,{"facility":217,"status":8,"city":218,"state":219,"zip":220,"country":110,"contacts":221,"geoPoint":226},"University of Iowa","Iowa City","Iowa","52242",[222],{"name":223,"role":114,"phone":224,"email":225},"Maureen Austin","319-356-0378","Maureen-Austin@uiowa.edu",{"lat":227,"lon":228},41.66113,-91.53017,{"facility":230,"status":8,"city":231,"state":232,"zip":233,"country":110,"contacts":234,"geoPoint":239},"Johns Hopkins Medical Institute","Baltimore","Maryland","21287",[235],{"name":236,"role":114,"phone":237,"email":238},"Alex Thompson","410-955-5734","athomp43@jhmi.edu",{"lat":240,"lon":241},39.29038,-76.61219,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":110,"contacts":247,"geoPoint":252},"Boston Children's Hospital","Boston","Massachusetts","02115",[248],{"name":249,"role":114,"phone":250,"email":251},"Vascular Anomalies Center","617-355-5226","vascular@childrens.harvard.edu",{"lat":253,"lon":254},42.35843,-71.05977,{"facility":256,"status":8,"city":257,"state":258,"zip":259,"country":110,"contacts":260,"geoPoint":264},"Corewell Health","Grand Rapids","Michigan","49503",[261],{"name":262,"role":114,"email":263},"Amanda Bartolovic","Amanda.bartolovic@corewellhealth.org",{"lat":265,"lon":266},42.96336,-85.66809,{"facility":268,"status":8,"city":269,"state":270,"zip":271,"country":110,"contacts":272,"geoPoint":277},"Mayo Clinic","Rochester","Minnesota","55905",[273],{"name":274,"role":114,"phone":275,"email":276},"Mary Manyara","507-266-3212","Manyara.mary@mayo.edu",{"lat":278,"lon":279},44.02163,-92.4699,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":110,"contacts":285,"geoPoint":289},"Washington University School of Medicine","St Louis","Missouri","63110",[286],{"name":287,"role":114,"email":288},"Allison Barnwell","pedshemonctrialreferral@wustl.edu",{"lat":290,"lon":291},38.62727,-90.19789,{"facility":293,"status":8,"city":294,"state":294,"zip":295,"country":110,"geoPoint":296},"NYU Langone Health","New York","10016",{"lat":297,"lon":298},40.71427,-74.00597,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":110,"contacts":304,"geoPoint":309},"UNC Chapel Hill","Chapel Hill","North Carolina","27599",[305],{"name":306,"role":114,"phone":307,"email":308},"Miriam Davis","919-966-2333","miriam.davis@unc.edu",{"lat":310,"lon":311},35.9132,-79.05584,{"facility":313,"status":8,"city":314,"state":315,"zip":316,"country":110,"contacts":317,"geoPoint":322},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[318],{"name":319,"role":114,"phone":320,"email":321},"Lexie Price","513- 803-0226","Sarah.price@cchmc.org",{"lat":323,"lon":324},39.12711,-84.51439,{"facility":326,"status":8,"city":327,"state":315,"zip":328,"country":110,"contacts":329,"geoPoint":334},"Cleveland Clinic Children's","Cleveland","44195",[330],{"name":331,"role":114,"phone":332,"email":333},"Ana Beatriz Ferreira Alves","216-636-1926","ferreia2@ccf.org",{"lat":335,"lon":336},41.4995,-81.69541,{"facility":338,"status":8,"city":339,"state":340,"zip":341,"country":110,"contacts":342,"geoPoint":348},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[343],{"name":344,"role":114,"phone":345,"phoneExt":346,"email":347},"Melissa Casey","267-426-9188","Option #4","caseyma@chop.edu",{"lat":349,"lon":350},39.95238,-75.16362,{"facility":352,"status":8,"city":353,"state":354,"zip":355,"country":110,"contacts":356,"geoPoint":361},"Texas Children's Hospital","Houston","Texas","77030",[357],{"name":358,"role":114,"phone":359,"email":360},"Gaylon Stevenson","832-824-1518","gnsteve1@texaschildrens.org",{"lat":362,"lon":363},29.76328,-95.36327,{"facility":365,"status":8,"city":366,"state":367,"zip":368,"country":110,"contacts":369,"geoPoint":374},"Seattle Children's Hospital","Seattle","Washington","98101",[370],{"name":371,"role":114,"phone":372,"email":373},"Whitney Eng","206-884-4626","Whitney.Eng@seattlechildrens.org",{"lat":375,"lon":376},47.60621,-122.33207,{"facility":378,"status":8,"city":379,"state":380,"zip":381,"country":110,"contacts":382,"geoPoint":386},"University of Wisconsin, Madison","Madison","Wisconsin","53715",[383],{"name":384,"role":114,"email":385},"Department of Dermatology","info@clinicaltrials.wisc.edu",{"lat":387,"lon":388},43.07305,-89.40123,{"facility":390,"status":8,"city":391,"state":392,"zip":393,"country":394,"contacts":395,"geoPoint":400},"Sydney Children's Hospital, Randwick","Randwick","New South Wales","2031","Australia",[396],{"name":397,"role":114,"phone":398,"email":399},"Sandra Montez","+610293821980","sandra.montez@health.nsw.gov.au",{"lat":401,"lon":402},-33.91439,151.24895,{"facility":404,"status":8,"city":405,"state":406,"zip":407,"country":394,"contacts":408,"geoPoint":413},"Children's Health Queensland Hospital and Health","South Brisbane","Queensland","4101",[409],{"name":410,"role":114,"phone":411,"email":412},"Melanie Jackson","+61730697631","oncology-research@health.qld.gov.au",{"lat":414,"lon":415},-27.48034,153.02049,{"facility":417,"status":8,"city":418,"state":419,"zip":420,"country":394,"contacts":421,"geoPoint":426},"Monash Health","Clayton","Victoria","3168",[422],{"name":423,"role":114,"phone":424,"email":425},"Maurizio Pacilli","+613857283828","maurizio.pacilli@monash.edu",{"lat":427,"lon":428},-37.91667,145.11667,{"facility":430,"status":8,"city":431,"state":419,"zip":432,"country":394,"contacts":433,"geoPoint":438},"Royal Melbourne Hospital","Parkville","3050",[434],{"name":435,"role":114,"phone":436,"email":437},"Dermatology Research","+61393424542","dermatologyresearch@mh.org.au",{"lat":439,"lon":440},-37.78333,144.95,{"facility":442,"status":8,"city":431,"state":419,"zip":443,"country":394,"contacts":444,"geoPoint":453},"Murdoch Children's Research Institute","3052",[445,449],{"name":446,"role":114,"phone":447,"email":448},"Anthony Penington","+61393454545","Tony.Penington@rch.org.au",{"name":450,"role":114,"phone":451,"email":452},"Trish Moreno","+61399366298","Trish.moreno@mcri.edu.au",{"lat":439,"lon":440},{"facility":455,"status":8,"city":456,"country":457,"contacts":458,"geoPoint":467},"UC Louvain","Ottignies-Louvain-la-Neuve","Belgium",[459,463],{"name":460,"role":114,"phone":461,"email":462},"Emmanuel Seront","+3227649475","emmanuel.seront@saintluc.uclouvain.be",{"name":464,"role":114,"phone":465,"email":466},"An Van Damme","+3227645106","an.vandamme@saintluc.uclouvain.be",{"lat":468,"lon":469},50.66714,4.55023,{"facility":471,"status":8,"city":472,"zip":473,"country":474,"geoPoint":475},"Necker Hospital","Paris","75015","France",{"lat":476,"lon":477},48.85341,2.3488,{"facility":479,"status":8,"city":480,"zip":481,"country":481,"contacts":482,"geoPoint":487},"University of Halle","Halle","Germany",[483],{"name":484,"role":114,"phone":485,"email":486},"Simone Hettmer","+493455572388","simone.hettmer@uk-halle.de",{"lat":488,"lon":489},51.48158,11.97947,{"facility":491,"status":8,"city":492,"zip":493,"country":494,"contacts":495,"geoPoint":500},"Children's Health Ireland at Crumlin","Dublin","D12 N512","Ireland",[496],{"name":497,"role":114,"phone":498,"email":499},"Breda Kane","014096100","Breda.kane@childrenshealthireland.ie",{"lat":501,"lon":502},53.33306,-6.24889,{"facility":504,"status":8,"city":505,"zip":506,"country":507,"contacts":508,"geoPoint":513},"Ospedale Maggiore Policlinico","Milan","20122","Italy",[509],{"name":510,"role":114,"phone":511,"email":512},"Dr. Riccardo Cavalli","0255035355","riccardo.cavalli@policlinico.mi.it",{"lat":514,"lon":515},45.46427,9.18951,{"facility":517,"status":8,"city":518,"zip":519,"country":507,"contacts":520,"geoPoint":525},"IRCCS Fondazione Policlinico Universitario A. Gemelli","Roma","00168",[521],{"name":522,"role":114,"phone":523,"email":524},"Dr. Chiara Leoni","+39 06 3015 4584","chiara.leoni@policlinicogemelli.it",{"lat":526,"lon":527},44.99364,11.10642,{"facility":529,"status":8,"city":518,"country":507,"contacts":530,"geoPoint":535},"Ospedale Pediatrico Bambino Gesù IRCCS",[531],{"name":532,"role":114,"phone":533,"email":534},"Andrea Diociaiuti","+390668592509","andrea.diociaiuti@opbg.net",{"lat":526,"lon":527},{"facility":537,"status":8,"city":538,"country":507,"contacts":539,"geoPoint":544},"A.O.U Città della Salute e della Scienza di Torino","Torino",[540],{"name":541,"role":114,"phone":542,"email":543},"Dr. Alessandro Mussa","+390113135689","alessandro.mussa@unito.it",{"lat":545,"lon":546},44.88856,11.99138,{"facility":548,"status":8,"city":549,"country":550,"contacts":551,"geoPoint":556},"Hospital Universitario A Coruña","A Coruña","Spain",[552],{"name":553,"role":114,"phone":554,"email":555},"Servicio Cirugía Pediátrica CHUAC","34981178128","cirugia.infantil.chuac@sergas.es",{"lat":557,"lon":558},43.37135,-8.396,{"facility":560,"status":8,"city":561,"country":550,"contacts":562,"geoPoint":569},"Hospital Sant Joan de Deu","Barcelona",[563,566],{"name":564,"role":114,"email":565},"Eulalia Baslega Torres","eulalia.baselga@sjd.es",{"name":567,"role":114,"email":568},"Raquel Masip","raquel.masip@sjd.es",{"lat":570,"lon":571},41.38879,2.15899,{"facility":573,"status":8,"city":574,"country":550,"contacts":575,"geoPoint":580},"Hospital Universitario La Paz","Madrid",[576],{"name":577,"role":114,"phone":578,"email":579},"Juan Carlos López Gutiérrez","+34917277019","juanc.lopez@salud.madrid.org",{"lat":581,"lon":582},40.4165,-3.70256,{"facility":584,"status":8,"city":585,"zip":586,"country":587,"contacts":588,"geoPoint":593},"Chelsea and Westminster Hospital","London","SW10 9NH","United Kingdom",[589],{"name":590,"role":114,"phone":591,"email":592},"Rhian Bull","+44 0203 3155295","Rhian.Bull@nhs.net",{"lat":594,"lon":595},51.50853,-0.12574,{"facility":597,"status":8,"city":585,"country":587,"contacts":598,"geoPoint":603},"Great Ormond Street Hospital for Children",[599],{"name":600,"role":114,"phone":601,"email":602},"Maanasa Polubothu","+4402074059200","maanasa.polubothu@gosh.nhs.uk",{"lat":594,"lon":595},[605],{"name":606,"role":114,"phone":607,"email":608},"Relay Therapeutics, Inc","617-322-0731","ClinicalTrials@relaytx.com",[],[],[],{"nct_id":4,"conditions":613,"biomarkers":620},[614,615,616,617,618,619],"Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, and Skeletal\u002FSpinal Abnormalities Syndrome","Klippel Trenaunay syndrome","Lymphatic malformation","Megalencephaly capillary malformation","PIK3CA-Related Overgrowth Spectrum","Vascular malformation",[621],"PIK3CA Gene",{"nct_id":4,"found":623,"summary":624,"prompt_version":634},true,{"design":625,"status":626,"heading":627,"summary":628,"follow_up":629,"word_count":630,"commitments":631,"compensation":632,"drugs_mentioned":633},"This is a Phase 2, randomized study with 277 planned participants. It has three parts: dose selection, exploring different groups, and a randomized, double-blinded comparison against a placebo.","completed","Phase 2 Study of RLY-2608 for PIK3CA-Related Overgrowth and Malformations","This Phase 2 study, called ReInspire, is testing a drug called RLY-2608 for adults and children with PIK3CA-Related Overgrowth Spectrum (PROS) and other malformations caused by a specific genetic change (PIK3CA mutation). RLY-2608 is designed to target this specific mutation. The study aims to find the best dose of RLY-2608 and see how safe and effective it is. Success will be measured by how much the affected areas shrink. To join, you must have a clinical diagnosis of PROS or a related malformation, and a documented PIK3CA mutation. The study plans to enroll 277 participants, but its current status is unclear.","The study measures safety and tolerability at the end of every treatment cycle until discontinuation, and volumetric response at Baseline and Week 24.",101,"Not specified in the trial record.","Not stated in the trial record.",[38],"v2"]