[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476686":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":91,"collaborators":19,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":19,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":19,"enrollmentInfo":102,"targetDuration":19,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},{"fullName":5,"class":6},"Ranok Therapuetics Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RNK05047","EXPERIMENTAL","Dose-escalation of RNK05047 IV infusion",[13],"Drug: RNK05047",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Linda Grummer","Ranok Therapeutics","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Linda Grummer, RN, BSN","CONTACT","405-921-1605","lindagrummer@ranoktherapeutics.com",[32,46,56,65,82],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":19},"Emory University Winship Cancer Institute","COMPLETED","Atlanta","Georgia","30322","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-84.38798,33.749,{"lat":44,"lon":43},{"facility":47,"status":34,"city":48,"state":49,"zip":50,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":19},"Norton Cancer Institute","Louisville","Kentucky","40202",{"type":41,"coordinates":52},[53,54],-85.75941,38.25424,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":58,"zip":59,"country":38,"countryCode":39,"cosmosGeoPoint":60,"geoPoint":64,"contacts":19},"Weill Cornell - NY Presbyterian Hospital","New York","10065",{"type":41,"coordinates":61},[62,63],-74.00597,40.71427,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":41,"coordinates":74},[75,76],116.39723,39.9075,{"lat":76,"lon":75},[79],{"name":80,"role":81,"phone":19,"phoneExt":19,"email":19},"Ning Li, MD","PRINCIPAL_INVESTIGATOR",{"facility":83,"status":67,"city":68,"state":69,"zip":84,"country":71,"countryCode":72,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Beijing Cancer Hospital","100142",{"type":41,"coordinates":86},[75,76],{"lat":76,"lon":75},[89],{"name":90,"role":81,"phone":19,"phoneExt":19,"email":19},"Yuquin Song, MD PhD",{"type":92,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100476686","phase-1-a-study-of-rnk05047-in-subjects-with-advanced-solid-tumorsdiffuse-large-b-cell-lymphoma-champ-1-100476686",false,"NCT05487170","A Study of RNK05047 in Subjects With Advanced Solid Tumors\u002FDiffuse Large B-cell Lymphoma (CHAMP-1)","A Phase 1\u002F2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)","Inclusion Criteria:\n\n* Pathologically documented locally advanced or metastatic solid tumor\n* Refractory or intolerant to all available standard-of-care therapies for advanced disease\n* Measurable disease\n* Archived tumor tissue collected\n* ECOG Performance Status of 0 or 1\n* BMI ≥ 18 kg\u002Fm2\n* Adequate liver, renal, hematologic, and coagulation parameters\n* Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion\n* Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.\n* Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.\n\nExclusion Criteria:\n\n* Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1\n* Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia\n* Presence or suspicion of active central nervous system (CNS) metastases and\u002For leptomeningeal carcinomatosis\n* Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0\n* Known active infection with HIV, HTLV-1, hepatitis B or C\n* Women who are pregnant or breastfeeding\n* History of another malignancy unless the subject has been treated with curative intent for this malignancy","ALL","18 Years",{"count":103,"type":104},32,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE1","PHASE2","This is a first in human, Phase 1\u002F2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL).\n\nThis is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.",[111,112],"Advanced Solid Tumor","DLBCL",[114],"protein degrader","2025-02-27",{"date":117,"type":118},"2025-03-04","ACTUAL",{"date":120,"type":118},"2022-07-12",{"date":122,"type":104},"2025-09-01",{"name":124,"class":6},"Ranok Therapeutics (Hangzhou) Co., Ltd.",5]