[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432163":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":36,"responsibleParty":231,"collaborators":26,"id":233,"slug":234,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":26,"eligibilityCriteria":239,"healthyVolunteers":240,"sex":241,"minAge":242,"maxAge":26,"enrollmentInfo":243,"targetDuration":26,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":259,"whyStopped":26,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},{"fullName":5,"class":6},"Redx Pharma Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: RXC004 monotherapy","EXPERIMENTAL","Patients will receive RXC004 (2 mg once daily \\[QD\\], orally).\n\nPatients in Arm A may crossover to Arm B treatment if they have progressive disease on the first Response Evaluation Criteria in Solid Tumours, (RECIST) scan (if Arm B is open at the time of progression).",[13,14],"Drug: RXC004","Biological: Denosumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm B: RXC004 + nivolumab","Patients will receive RXC004 (1.5 mg QD, orally) in combination with nivolumab (480 mg every 4 weeks \\[q4w\\], intravenous \\[IV\\] infusion).\n\nArm B will be opened once a RP2D for RXC004 in combination with nivolumab is established in the phase I dose escalation study (NCT03447470). RXC004 dose to be used in combination with nivolumab will be based on data from the phase 1 study (NCT03447470).",[13,19,14],"Biological: Nivolumab",[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","RXC004","RXC004 will be administered orally, 2 mg QD (Monotherapy); and 1.5 mg QD (Combination therapy)\n\nDose Formulation: 0.5 mg or 1 mg capsules.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BIOLOGICAL","Nivolumab","Nivolumab will be administered via IV infusion, 480 mg q4w.",[16],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Denosumab","Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.\n\nUse: Prophylactic",[9,16],[37,50,60,70,80,89,100,109,115,121,127,138,144,150,159,168,180,189,198,204,213,222],{"facility":38,"status":26,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"Providence Medical Foundation","Santa Rosa","California","95403","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.71443,38.44047,{"lat":48,"lon":47},{"facility":51,"status":26,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":26},"Community Health Network Cancer Center North - Community Hospital Network","Indianapolis","Indiana","46250",{"type":45,"coordinates":56},[57,58],-86.15804,39.76838,{"lat":58,"lon":57},{"facility":61,"status":26,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":26},"OptumCare Cancer Care","Las Vegas","Nevada","89102",{"type":45,"coordinates":66},[67,68],-115.13722,36.17497,{"lat":68,"lon":67},{"facility":71,"status":26,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":26},"UT MD Anderson Cancer Center","Houston","Texas","77030-4000",{"type":45,"coordinates":76},[77,78],-95.36327,29.76328,{"lat":78,"lon":77},{"facility":81,"status":26,"city":82,"state":73,"zip":83,"country":42,"countryCode":43,"cosmosGeoPoint":84,"geoPoint":88,"contacts":26},"Lumi Research","Kingswood","77339",{"type":45,"coordinates":85},[86,87],-96.97473,32.57153,{"lat":87,"lon":86},{"facility":90,"status":26,"city":91,"state":92,"zip":93,"country":94,"countryCode":26,"cosmosGeoPoint":95,"geoPoint":99,"contacts":26},"National Cancer Center","Goyang-si","Gyeonggido [Kyonggi-do]","10408","South Korea",{"type":45,"coordinates":96},[97,98],126.835,37.65639,{"lat":98,"lon":97},{"facility":101,"status":26,"city":102,"state":26,"zip":103,"country":94,"countryCode":26,"cosmosGeoPoint":104,"geoPoint":108,"contacts":26},"Seoul National University Hospital","Seoul","03080",{"type":45,"coordinates":105},[106,107],126.9784,37.566,{"lat":107,"lon":106},{"facility":110,"status":26,"city":102,"state":26,"zip":111,"country":94,"countryCode":26,"cosmosGeoPoint":112,"geoPoint":114,"contacts":26},"Severance Hospital, Yonsei University Health System - Medical Oncology","3722",{"type":45,"coordinates":113},[106,107],{"lat":107,"lon":106},{"facility":116,"status":26,"city":102,"state":26,"zip":117,"country":94,"countryCode":26,"cosmosGeoPoint":118,"geoPoint":120,"contacts":26},"Asan Medical Center - Oncology","5505",{"type":45,"coordinates":119},[106,107],{"lat":107,"lon":106},{"facility":122,"status":26,"city":102,"state":26,"zip":123,"country":94,"countryCode":26,"cosmosGeoPoint":124,"geoPoint":126,"contacts":26},"Samsung Medical Center - Hematology-Oncology","6351",{"type":45,"coordinates":125},[106,107],{"lat":107,"lon":106},{"facility":128,"status":26,"city":129,"state":26,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":26},"Hospital del Mar","Barcelona","08003","Spain","ES",{"type":45,"coordinates":134},[135,136],2.15899,41.38879,{"lat":136,"lon":135},{"facility":139,"status":26,"city":129,"state":26,"zip":140,"country":131,"countryCode":132,"cosmosGeoPoint":141,"geoPoint":143,"contacts":26},"Hospital Universitario Vall d'Hebrón","08035",{"type":45,"coordinates":142},[135,136],{"lat":136,"lon":135},{"facility":145,"status":26,"city":129,"state":26,"zip":146,"country":131,"countryCode":132,"cosmosGeoPoint":147,"geoPoint":149,"contacts":26},"Hospital Clìnic de Barcelona","08036",{"type":45,"coordinates":148},[135,136],{"lat":136,"lon":135},{"facility":151,"status":26,"city":152,"state":26,"zip":153,"country":131,"countryCode":132,"cosmosGeoPoint":154,"geoPoint":158,"contacts":26},"Hospital Universitario 12 de Octubre","Madrid","28041",{"type":45,"coordinates":155},[156,157],-3.70256,40.4165,{"lat":157,"lon":156},{"facility":160,"status":26,"city":161,"state":26,"zip":162,"country":131,"countryCode":132,"cosmosGeoPoint":163,"geoPoint":167,"contacts":26},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":45,"coordinates":164},[165,166],-5.97317,37.38283,{"lat":166,"lon":165},{"facility":169,"status":26,"city":170,"state":171,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":26},"Beatson West of Scotland Cancer Centre - Oncology","Glasgow","Scotland","G12 0YN","United Kingdom","UK",{"type":45,"coordinates":176},[177,178],-4.25763,55.86515,{"lat":178,"lon":177},{"facility":181,"status":26,"city":182,"state":26,"zip":183,"country":173,"countryCode":174,"cosmosGeoPoint":184,"geoPoint":188,"contacts":26},"Queen Elizabeth Hospital - Clinical Reasearch","Birmingham","B152TH",{"type":45,"coordinates":185},[186,187],-1.89983,52.48142,{"lat":187,"lon":186},{"facility":190,"status":26,"city":191,"state":26,"zip":192,"country":173,"countryCode":174,"cosmosGeoPoint":193,"geoPoint":197,"contacts":26},"University College of London (UCL)","London","NW1 2PG",{"type":45,"coordinates":194},[195,196],-0.12574,51.50853,{"lat":196,"lon":195},{"facility":199,"status":26,"city":191,"state":26,"zip":200,"country":173,"countryCode":174,"cosmosGeoPoint":201,"geoPoint":203,"contacts":26},"The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital","SW3 6JJ",{"type":45,"coordinates":202},[195,196],{"lat":196,"lon":195},{"facility":205,"status":26,"city":206,"state":26,"zip":207,"country":173,"countryCode":174,"cosmosGeoPoint":208,"geoPoint":212,"contacts":26},"Christie Hospital","Manchester","CB2 0QQ",{"type":45,"coordinates":209},[210,211],-2.23743,53.48095,{"lat":211,"lon":210},{"facility":214,"status":26,"city":215,"state":26,"zip":216,"country":173,"countryCode":174,"cosmosGeoPoint":217,"geoPoint":221,"contacts":26},"Oxford Cancer Centre","Oxford","OX3 7LJ",{"type":45,"coordinates":218},[219,220],-1.25596,51.75222,{"lat":220,"lon":219},{"facility":223,"status":26,"city":224,"state":26,"zip":225,"country":173,"countryCode":174,"cosmosGeoPoint":226,"geoPoint":230,"contacts":26},"The Royal Marsden Hospital (Surrey)","Surrey Quays","SM25PT",{"type":45,"coordinates":227},[228,229],-0.04802,51.49353,{"lat":229,"lon":228},{"type":232,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100432163","phase-2-a-study-to-assess-efficacy-of-rxc004---nivolumab-in-ring-finger-protein-43-rnf43-or-r-spondin-rspo-aberrated-metastatic-microsatellite-stable-colorectal-cancer-after-progression-on-standard-of-care-soc-100432163",true,"NCT04907539","A Study to Assess Efficacy of RXC004 +\u002F- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)","A Multi-arm, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy of RXC004 in Monotherapy and in Combination With Nivolumab, in Patients With Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer Who Have Progressed Following Therapy With Current Standard of Care (PORCUPINE)","Inclusion Criteria:\n\n* Histological documentation of metastatic (Stage IV) Colorectal cancer (CRC) and\n\n  1. Documented tumour tissue aberration in RNF43 and\u002For RSPO\n  2. Documented confirmation of microsatellite stable (MSS) status\n* Patients must have had documented radiological progression following a minimum of 1 prior SOC treatment regimen for metastatic disease\n* Eastern Cooperative Oncology Group performance status 0 or 1\n* At least one lesion that is measurable by RECIST 1.1 at baseline\n* Patients must have at least one lesion suitable for biopsy at screening and be willing to provide mandatory tumour biopsy samples\n* Patients with adequate organ functions\n* Female patients of childbearing potential must have a negative pregnancy test prior to start of dosing\n* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 5 months after the last dose of study drug.\n\nFor patients on RXC004 monotherapy treatment (Arm A) the following inclusion criteria will also apply to enter the RXC004 + nivolumab treatment phase:\n\n* Patients must have had documented RECIST1.1 defined radiological progression on RXC004 monotherapy treatment on the first scheduled scan (week 8 +\u002F- 1 week)\n* Patients must receive Cycle 1 Day 1 of combination study treatment within 28 days of the first scheduled scan (week 8 +\u002F- 1 week).\n\nExclusion Criteria:\n\n* Prior therapy with a compound of the same mechanism of action as RXC004\n* Patients at higher risk of bone fractures\n* Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment\n* Patients who have any history of an active (requiring treatment) other malignancy within 2 years of study entry\n* Patients with known or suspected brain metastases\n* Use of anti-neoplastic agents, immunosuppressants and other investigational drugs\n* Patients with a known hypersensitivity to any RXC004 excipients\n* Patients with a contra-indication for denosumab treatment\n* Patients who are pregnant or breast-feeding\n* Use of any live or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment\n* Patients with a mean resting corrected QTcF \\>470 ms, obtained from triplicate electrocardiograms performed at screening\n\nFor patients on RXC004 + nivolumab combination treatment (Arm B or Arm A RXC004 + nivolumab treatment phase):\n\n* Patients with any contraindication to the use of nivolumab\n* Patients with active or prior documented autoimmune or inflammatory disorders within the past 5 years\n* Patients with active infections, including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus\n* Patients with a history of allogeneic organ transplant or active primary immunodeficiency\n* Patients with a known hypersensitivity to nivolumab or any of the excipients of the product",false,"ALL","18 Years",{"count":244,"type":245},25,"ACTUAL","INTERVENTIONAL",[248],"PHASE2","This is a Phase II, open label, multicentre, multi-arm, study to evaluate the preliminary efficacy and safety of RXC004 as monotherapy and in combination with nivolumab in patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, microsatellite stable (MSS), colorectal cancer (CRC), that have progressed following current standard of care treatment.",[251],"Colorectal Cancer",[253,23,29,254,255,256,257,258],"Open label","Ring finger protein 43","R-spondin","Efficacy","Safety","Pharmacokinetics","COMPLETED","2025-03-26",{"date":262,"type":245},"2025-04-16",{"date":264,"type":245},"2021-11-08",{"date":266,"type":245},"2024-04-02",{"name":5,"class":6},22]