[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-squamous-cell-carcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100614791","phase-1-first-in-human-study-of-plx-61639-in-locally-advanced-or-metastatic-solid-tumors-100614791",false,"NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval","ALL","18 Years",{"count":19,"type":20},155,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[26,27,28,29,30,31,32,33,34,35],"Esophageal Squamous Cell Carcinoma","Gastric Adenocarcinoma","Gastric Squamous Cell Carcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Metastatic Solid Tumor","Non-Small Cell Lung Carcinoma","Esophageal Adenocarcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","Advanced Solid Tumor","RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-12","ACTUAL",{"date":42,"type":40},"2025-12-01",{"date":44,"type":20},"2030-09",{"name":46,"class":47},"Plexium, Inc.","INDUSTRY",10]