[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ureteral-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ureteral-neoplasms":29},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100486489","phase-1-forager-1-a-study-of-loxo-435-ly3866288-in-participants-with-cancer-with-a-change-in-a-gene-called-fgfr3-100486489",false,"NCT05614739","FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3","FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations","FORAGER-1","Inclusion Criteria:\n\n* Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable\n\n  * Cohort A1: Presence of an alteration in FGFR3 or its ligands\n  * Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n  * Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic\n  * Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n* Measurability of disease:\n\n  * Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)\n  * Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1\n* Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5\n\n  * Less than or equal to 2 for Cohorts B1, B2, B4, and C1\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.\n  * Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting\n  * There is no restriction on number of prior therapies\n* Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC\n* FGFR inhibitor specific requirements:\n\n  * Cohort A1\u002FA2\u002FB3: Prior FGFR inhibitor treatment is permitted but not required\n  * Cohort B1\u002FB4: Participants must have been previously treated with erdafitinib\n  * Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) malignancy\n* Untreated or uncontrolled CNS metastases\n* Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)\n* Active uncontrolled systemic infection or other clinically significant medical conditions\n* Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled","ALL","18 Years",{"count":20,"type":21},535,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.",[27,28,29],"Urinary Bladder Neoplasms","Neoplasm Metastasis","Ureteral Neoplasms",[31,32,33,34,35,36],"Bladder Cancer","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Renal Pelvis Cancer","Ureter Cancer","RECRUITING","2026-06-17",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":41},"2023-01-12",{"date":45,"type":21},"2027-06",{"name":47,"class":48},"Eli Lilly and Company","INDUSTRY",82]