[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ensem Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"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":25,"conditions":26,"keywords":29,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100592470","phase-1-phase-12-study-of-etx-636-in-participants-with-advanced-solid-tumors-100592470",false,"NCT06993844","Phase 1\u002F2 Study of ETX-636 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.\n* Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status score of 0 or 1.\n* Adequate organ function.\n\nAdditional key inclusion criterion for Parts B and C:\n\n\\- Confirmed metastatic or locally advanced HR+\u002FHER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4\u002F6 inhibitor and at least 1 prior anti-estrogen therapy.\n\nKey Exclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.\n* Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.","ALL","18 Years",{"count":19,"type":20},233,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Phase 1\u002F2, open-label study of ETX-636 in participants with advanced solid tumors",[27,28],"Advanced Solid Tumors","Advanced Breast Cancer",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"cancer","breast cancer","solid tumors","PIK3CA","PI3Kα inhibitor","Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","HER2-negative breast cancer","HR-positive breast cancer","Gynecologic cancer","Endometrial cancer","Ovarian cancer","Cervical cancer","Head and neck cancer","Head and neck squamous cell carcinoma","Fulvestrant","Antineoplastic Agents","PI3Kα","PI3K alpha","PI3Kα mutation","Alpelisib","Estrogen Receptor Antagonists","Estrogen Antagonists","Hormone Receptor Antagonists","Hormone Antagonists","Hormones, Hormone Substitutes, and Hormone Antagonists","Physiological Effects of Drugs","PIK3CA mutation","RECRUITING","2026-06-21",{"date":63,"type":64},"2026-06-23","ACTUAL",{"date":66,"type":64},"2025-06-10",{"date":68,"type":20},"2027-12-30",{"name":70,"class":71},"Ensem Therapeutics","INDUSTRY",15,""]