[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Terremoto Biosciences Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379",false,"NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply","ALL","18 Years",{"count":18,"type":19},205,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[26,27,28,29,30,31,32,33],"Breast Cancer","Endometrial Cancer","Ovarian Cancer","Lung Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Solid Tumor","Cervical Cancer",[35,26,36,37],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-","RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-22","ACTUAL",{"date":44,"type":42},"2025-09-23",{"date":46,"type":19},"2029-02-28",{"name":48,"class":49},"Terremoto Biosciences Inc.","INDUSTRY",15,""]