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L'Hospitalet","Barcelona","08908","Spain",{"type":68,"coordinates":722},[723,724],2.15899,41.38879,{"lat":724,"lon":723},{"facility":727,"status":62,"city":728,"state":42,"zip":729,"country":720,"cosmosGeoPoint":730,"geoPoint":734,"contacts":42},"Fundacion MD Anderson International Espana","Madrid","28033",{"type":68,"coordinates":731},[732,733],-3.70256,40.4165,{"lat":733,"lon":732},{"facility":736,"status":62,"city":728,"state":42,"zip":737,"country":720,"cosmosGeoPoint":738,"geoPoint":740,"contacts":42},"Hospital Universitario 12 de Octubre","28041",{"type":68,"coordinates":739},[732,733],{"lat":733,"lon":732},{"facility":742,"status":62,"city":728,"state":42,"zip":743,"country":720,"cosmosGeoPoint":744,"geoPoint":746,"contacts":42},"South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC","28050",{"type":68,"coordinates":745},[732,733],{"lat":733,"lon":732},{"facility":748,"status":62,"city":749,"state":42,"zip":750,"country":720,"cosmosGeoPoint":751,"geoPoint":755,"contacts":42},"Hospital Universitario Marques De Valdecilla","Santander","39008",{"type":68,"coordinates":752},[753,754],-3.80493,43.46589,{"lat":754,"lon":753},{"facility":757,"status":62,"city":758,"state":42,"zip":759,"country":760,"cosmosGeoPoint":761,"geoPoint":765,"contacts":42},"The Christie NHS Foundation Trust","Manchester","M20 4BX","United Kingdom",{"type":68,"coordinates":762},[763,764],-2.23743,53.48095,{"lat":764,"lon":763},{"facility":767,"status":62,"city":768,"state":42,"zip":769,"country":760,"cosmosGeoPoint":770,"geoPoint":774,"contacts":42},"Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield","S10 2SB",{"type":68,"coordinates":771},[772,773],-1.4659,53.38297,{"lat":773,"lon":772},{"type":776,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":787,"type":788},535,"ESTIMATED","INTERVENTIONAL",[791],"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.",[794,795,796],"Urinary Bladder Neoplasms","Neoplasm Metastasis","Ureteral Neoplasms",[798,799,800,801,802,803],"Bladder Cancer","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Renal Pelvis Cancer","Ureter Cancer","2026-06-17",{"date":806,"type":807},"2026-06-18","ACTUAL",{"date":809,"type":807},"2023-01-12",{"date":811,"type":788},"2027-06",{"name":5,"class":6},82]