[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659070":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":58,"interventions":75,"overallOfficials":51,"centralContacts":51,"locations":51,"responsibleParty":89,"collaborators":51,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":51,"enrollmentInfo":101,"targetDuration":51,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":51,"overallStatus":113,"whyStopped":51,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":51},{"fullName":5,"class":6},"KymaThera, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":51},[9,13,17,21,24,27,30],{"measure":10,"description":11,"timeFrame":12},"Maximum Tolerated Dose (MTD)\u002FMaximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)","Determination of the MTD\u002FMED and RP2D of K-1728 administered as monotherapy and in combination","Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)",{"measure":14,"description":15,"timeFrame":16},"Incidence of Dose-Limiting Toxicities (DLTs)","Number and percentage of participants experiencing a dose-limiting toxicity during the DLT-evaluation period with of K-1728 administered as monotherapy and in combination","Initiation of study drug through Cycle 1 (28 days)",{"measure":18,"description":19,"timeFrame":20},"Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Number and percentage of participants with adverse events and serious adverse events with K-1728 administered as a monotherapy and in combination","From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)",{"measure":22,"description":23,"timeFrame":20},"Changes in laboratory parameters","Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination",{"measure":25,"description":26,"timeFrame":20},"Changes in vital signs","Compared to baseline, changes in vital signs with K-1728 administered as monotherapy and in combination",{"measure":28,"description":29,"timeFrame":20},"Changes in electrocardiogram (ECG) parameters","Compared to baseline, changes in ECG parameters (including QT interval, QTc interval, QRS complex, and PR interval)",{"measure":31,"description":32,"timeFrame":20},"Changes in physical examination","Compared to baseline, changes in physical examination",[34,38,41,44,47],{"measure":35,"description":36,"timeFrame":37},"Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728","Cmax of K-1728 when administered as monotherapy or in combination","Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months",{"measure":39,"description":40,"timeFrame":37},"Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728","Tmax of K-1728 when administered as monotherapy or in combination",{"measure":42,"description":43,"timeFrame":37},"Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728","AUC of K-1728 when administered as monotherapy or in combination",{"measure":45,"description":46,"timeFrame":37},"Pharmacokinetics - Half-life (t1\u002F2) of K-1728 when administered as monotherapy or in combination","t1\u002F2 of K-1728 when administered as monotherapy or in combination",{"measure":48,"description":49,"timeFrame":50},"Preliminary Efficacy - Overall Response Rate (ORR)","Objective Response Rate (ORR) as assessed by RECIST v1.1","Initiation of study drug until disease progression, assessed up to approximately 24 months",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE",[59,65,70],{"label":60,"type":61,"description":62,"interventionNames":63},"K-1728 Monotherapy","EXPERIMENTAL","Participants receive K-1728 orally as monotherapy",[64],"Drug: K-1728",{"label":66,"type":61,"description":67,"interventionNames":68},"K-1728 + Endocrine Therapy","Participants receive K-1728 orally in combination with endocrine therapy",[64,69],"Drug: Fulvestrant",{"label":71,"type":61,"description":72,"interventionNames":73},"K-1728 + Endocrine Therapy + CDK4\u002F6 Inhibitor","Participants receive K-1728 orally in combination with endocrine therapy and a CDK4\u002F6 inhibitor",[64,69,74],"Drug: Palbociclib",[76,81,85],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":51},"DRUG","K-1728","K-1728 will be administered orally once daily in 28-day cycles",[66,71,60],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":51},"Fulvestrant","Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle",[66,71],{"type":77,"name":86,"description":87,"armGroupLabels":88,"otherNames":51},"Palbociclib","Palbociclib will be administered orally on Days 1-21 in 28-day cycles",[71],{"type":90,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100659070","phase-1-a-phase-12a-study-of-k-1728-in-advanced-solid-tumors-100659070",false,"NCT07861932","A Phase 1\u002F2a Study of K-1728 in Advanced Solid Tumors","A First-in-Human Study of K-1728 Administered Alone and in Combination in Participants With Advanced or Metastatic Solid Tumors","PIKYMA-01","Key Inclusion Criteria:\n\n* Adults with advanced or metastatic solid tumors who are able to provide consent\n* Documented activating PIK3CA mutation\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nKey Exclusion Criteria:\n\n* Active or untreated central nervous system disease\n* Clinical significant or uncontrolled cardiovascular disease\n* Significant or uncontrolled intercurrent illness\n* Pregnant or breastfeeding\n* Other protocol-defined exclusion criteria","ALL","18 Years",{"count":102,"type":103},110,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE1","PHASE2","This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.",[110,111,112],"Breast Neoplasms","Solid Tumors","PIK3CA Gene Mutation","NOT_YET_RECRUITING","2026-10-01",{"date":116,"type":117},"2026-10-06","ACTUAL",{"date":119,"type":103},"2026-10",{"date":121,"type":103},"2029-03",{"name":5,"class":6}]