[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655862":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":56,"overallOfficials":11,"centralContacts":62,"locations":68,"responsibleParty":117,"collaborators":11,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":11,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":11,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Recursion Pharmaceuticals Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)",null,"28 days",{"measure":14,"description":11,"timeFrame":15},"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","Up to 2 years",{"measure":17,"description":11,"timeFrame":15},"Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",[19,21,23,25,27,29,31,33,35,37],{"measure":20,"description":11,"timeFrame":15},"Maximum (Peak) Drug Concentration (Cmax) of REC-7735",{"measure":22,"description":11,"timeFrame":15},"Time to Reach Cmax following drug administration (Tmax) of REC-7735",{"measure":24,"description":11,"timeFrame":15},"Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735",{"measure":26,"description":11,"timeFrame":15},"Phase 1A: ORR According to Standard RECIST 1.1",{"measure":28,"description":11,"timeFrame":15},"Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1",{"measure":30,"description":11,"timeFrame":15},"Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1",{"measure":32,"description":11,"timeFrame":15},"Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1",{"measure":34,"description":11,"timeFrame":15},"Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1",{"measure":36,"description":11,"timeFrame":15},"Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1",{"measure":38,"description":11,"timeFrame":15},"Phase 1B: Overall Survival",{"allocation":40,"interventionModel":41,"interventionModelDescription":11,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":11},"NONE",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Phase 1A Dose Finding: REC-7735","EXPERIMENTAL","Participants will receive REC-7735 twice daily (BID).",[51],"Drug: REC-7735",{"label":53,"type":48,"description":54,"interventionNames":55},"Phase 1B Dose Expansion\u002FOptimization: REC-7735","Participants will receive REC-7735 BID.",[51],[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","REC-7735","Oral",[47,53],[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Recursion Pharmaceuticals","CONTACT","385-374-1724","clinicaltrials@recursionpharma.com",[69,87,102],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"START Midwest","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-85.66809,42.96336,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":11,"phoneExt":11,"email":86},"Hope Team Distribution List","hopeteam@startresearch.com",{"facility":88,"status":71,"city":89,"state":90,"zip":91,"country":75,"countryCode":76,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"NEXT Oncology - Dallas","Irving","Texas","75039",{"type":78,"coordinates":93},[94,95],-96.94889,32.81402,{"lat":95,"lon":94},[98],{"name":99,"role":65,"phone":100,"phoneExt":11,"email":101},"Clinical Trial Navigator","972-893-8800","fakinwale@nextoncology.com",{"facility":103,"status":71,"city":104,"state":105,"zip":106,"country":75,"countryCode":76,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"NEXT Virginia","Fairfax","Virginia","22031",{"type":78,"coordinates":108},[109,110],-77.30637,38.84622,{"lat":110,"lon":109},[113],{"name":114,"role":65,"phone":115,"phoneExt":11,"email":116},"Referral Coordinator","703-783-4518","mdelarosa@nextoncology.com",{"type":118,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655862","phase-1-rec-7735-in-participants-with-solid-tumors-100655862",false,"NCT07819136","REC-7735 in Participants With Solid Tumors","A Phase 1 \u002F 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors","Key Inclusion Criteria:\n\n* Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and\u002For blood (circulating tumor deoxyribonucleic acid \\[ctDNA\\]).\n* For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy.\n* All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy.\n\nKey Exclusion Criteria:\n\n* Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.\n* Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.\n* Major surgery within 6 weeks from treatment initiation.\n* Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment.\n* Recent or ongoing serious infection.\n* Recent prior systemic anti-cancer treatment.\n* Known clinically significant UGT1A1 deficiency, including Gilbert's syndrome (for example, documented homozygous UGT1A1\\*28)\n* Has an established diagnosis of uncontrolled diabetes mellitus defined as meeting any one of the following:\n\nNOTE: This criterion is not applicable to those participants enrolling in the Phase 1B Dose Expansion cohort designated for hyperglycemia vulnerable participants\n\n* Glycated hemoglobin (HbA1c) ≥8%\n* Currently requiring insulin\n* Fasting blood glucose (FBG) ≥140 milligrams (mg)\u002Fdeciliter (dL) (7.8 millimoles \\[mmol\\]\u002Fliter \\[L\\]) in the past 30 days prior to dosing\n\nNOTE: Two FBG samples must be drawn at least seven days apart from each other.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":129,"type":130},90,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE1","PHASE2","The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.",[137],"Solid Tumors",[139,140],"PIK3CA-H1047R","Cancer","2026-09-25",{"date":143,"type":144},"2026-09-29","ACTUAL",{"date":146,"type":130},"2026-09",{"date":148,"type":130},"2031-01",{"name":5,"class":6},3]