[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06220864":3,"trial-entities:NCT06220864":298,"trial-summary:NCT06220864":302},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":55,"secondary_outcomes":64,"sex":65,"minimum_age":66,"maximum_age":15,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":82,"locations":85,"central_contacts":290,"overall_officials":295,"references":296,"see_also_links":297},"NCT06220864","SNV1521-101","SNV1521 in Participants With Advanced Solid Tumors","A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors","RECRUITING","2027-12","2026-06","2026-06-25","2024-02-23","Synnovation Therapeutics, Inc.","INDUSTRY",null,"This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.",[18],"Advanced Solid Tumor",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE1",{"count":25,"type":26},400,"ESTIMATED",[28,41,45,50],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","SNV1521","SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.",[33,34,35,36,37,38,39,40],"Combination Dose Escalation","Dose Expansion for Breast Cancer","Dose Expansion for Metastatic Castration Resistant Prostate Cancer","Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer","Dose Expansion for Pancreatic Ductal Adenocarcinoma","Dose Expansion for Solid Tumors with Brain Metastases","Monotherapy Dose Escalation","Monotherapy Dose Expansion",{"type":29,"name":42,"description":43,"armGroupLabels":44},"DB-1310","DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.",[33],{"type":29,"name":46,"description":47,"armGroupLabels":48},"Abiraterone","Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.",[49],"Combination 1 Dose Expansion for mCRPC or mCSPC",{"type":29,"name":51,"description":52,"armGroupLabels":53},"Darolutamide","Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.",[54],"Combination 2 Dose Expansion for mCRPC or mCSPC",[56,60],{"measure":57,"description":58,"timeFrame":59},"Safety of SNV1521","Treatment emergent adverse events (TEAEs)","From first dose through last dose (up to 13 months)",{"measure":61,"description":62,"timeFrame":63},"Tolerability of SNV1521","Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)","DLTs: From first dose through completion of first cycle (28 days)",[],"ALL","18 Years",false,{"inclusion":69,"exclusion":74,"raw_text":81},[70,71,72,73],"Advanced or metastatic solid tumor malignancy","Evaluable or Measurable disease (RECIST 1.1 Criteria).","ECOG Performance Status 0 or 1.","Life expectancy \\> 3 months",[75,76,77,78,79,80],"History of other malignancy within the past 2 years","Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia","Significant cardiovascular disease within 6 months","Significant gastrointestinal disease","HIV infection with a CD4+ T-cell count \\\u003C 200 cells\u002FμL and\u002For a detectable viral load","Liver dysfunction","Inclusion Criteria:\n\n* Advanced or metastatic solid tumor malignancy\n* Evaluable or Measurable disease (RECIST 1.1 Criteria).\n* ECOG Performance Status 0 or 1.\n* Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* History of other malignancy within the past 2 years\n* Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia\n* Significant cardiovascular disease within 6 months\n* Significant gastrointestinal disease\n* HIV infection with a CD4+ T-cell count \\\u003C 200 cells\u002FμL and\u002For a detectable viral load\n* Liver dysfunction",[83,84],"ADULT","OLDER_ADULT",[86,95,103,111,119,127,136,144,152,159,167,181,193,205,216,225,233,241,248,255,263,267,275,279,286],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Smilow Cancer Hospital at Yale New Haven","New Haven","Connecticut","06511","United States",{"lat":93,"lon":94},41.30815,-72.92816,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":91,"geoPoint":100},"Thomas Jefferson University","Philadelphia","Pennsylvania","19144",{"lat":101,"lon":102},39.95238,-75.16362,{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":91,"geoPoint":108},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"lat":109,"lon":110},36.16589,-86.78444,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":91,"geoPoint":116},"The University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"lat":117,"lon":118},29.76328,-95.36327,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":91,"geoPoint":124},"START Center for Cancer Care","West Valley City","Utah","84119",{"lat":125,"lon":126},40.69161,-112.00105,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Scientia Clinical Research","Randwick","New South Wales","2031","Australia",{"lat":134,"lon":135},-33.91439,151.24895,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":132,"geoPoint":141},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",{"lat":142,"lon":143},-27.48855,153.03655,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":132,"geoPoint":149},"Monash Health","Clayton","Victoria","3168",{"lat":150,"lon":151},-37.91667,145.11667,{"facility":153,"status":8,"city":154,"state":147,"zip":155,"country":132,"geoPoint":156},"The Alfred Hospital","Melbourne","3004",{"lat":157,"lon":158},-37.814,144.96332,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":132,"geoPoint":164},"Linear Clinical Research","Crawley","Western Australia","6009",{"lat":165,"lon":166},-31.98418,115.81603,{"facility":168,"status":8,"city":169,"zip":170,"country":171,"contacts":172,"geoPoint":178},"The Institut Jules Bordet","Brussels","1070","Belgium",[173],{"name":174,"role":175,"phone":176,"email":177},"Nuria Kotecki","CONTACT","+32 2 541 31 11","nuria.kotecki@hubruxelles.be",{"lat":179,"lon":180},50.85045,4.34878,{"facility":182,"status":8,"city":183,"zip":184,"country":171,"contacts":185,"geoPoint":190},"University Center for Clinical Research Antwerp (UNICCRA)","Edegem","2650",[186],{"name":187,"role":175,"phone":188,"email":189},"Hans Prenen","32 3 821 46 67","research.oncologie@uza.be",{"lat":191,"lon":192},51.15662,4.44504,{"facility":194,"status":8,"city":195,"zip":196,"country":171,"contacts":197,"geoPoint":202},"AZ Maria Middelares","Ghent","9000",[198],{"name":199,"role":175,"phone":200,"email":201},"Christof Vulsteke","+32 9 2469522","christof.vulsteke@uantwerpen.be",{"lat":203,"lon":204},51.05,3.71667,{"facility":206,"status":8,"city":207,"zip":208,"country":171,"contacts":209,"geoPoint":213},"AZ Groeninge","Kortrijk","8500",[210],{"name":211,"role":175,"phone":212,"email":212},"Karl Lesage","urologie@azgroeninge.be",{"lat":214,"lon":215},50.82803,3.26487,{"facility":217,"status":8,"city":218,"state":219,"zip":220,"country":221,"geoPoint":222},"Arthur J.E. Child Comprehensive Cancer Centre","Calgary","Alberta","T2N 5G2","Canada",{"lat":223,"lon":224},51.05011,-114.08529,{"facility":226,"status":8,"city":227,"state":228,"zip":229,"country":221,"geoPoint":230},"Princess Margaret Hospital","Toronto","Ontario","M5G 2M9",{"lat":231,"lon":232},43.70643,-79.39864,{"facility":234,"status":8,"city":235,"zip":236,"country":237,"geoPoint":238},"Institut Bergonie","Bordeaux","33076","France",{"lat":239,"lon":240},44.84124,-0.58046,{"facility":242,"status":8,"city":243,"zip":244,"country":237,"geoPoint":245},"UNICANCER - Centre Leon-Berard (CLB)","Lyon","69008",{"lat":246,"lon":247},45.74906,4.84789,{"facility":249,"status":8,"city":250,"zip":251,"country":237,"geoPoint":252},"Gustave Roussy","Villejuif","94805",{"lat":253,"lon":254},48.7939,2.35992,{"facility":256,"status":8,"city":257,"zip":258,"country":259,"geoPoint":260},"Istituto Clinico Humanitas","Milan","20089","Italy",{"lat":261,"lon":262},45.46427,9.18951,{"facility":264,"status":8,"city":257,"zip":265,"country":259,"geoPoint":266},"Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)","20141",{"lat":261,"lon":262},{"facility":268,"status":8,"city":269,"zip":270,"country":271,"geoPoint":272},"NEXT Oncology - Barcelona","Barcelona","08023","Spain",{"lat":273,"lon":274},41.38879,2.15899,{"facility":276,"status":8,"city":269,"zip":277,"country":271,"geoPoint":278},"Vall d'Hebron University Hospital","08035",{"lat":273,"lon":274},{"facility":280,"status":8,"city":281,"zip":282,"country":271,"geoPoint":283},"The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro","Madrid","28050",{"lat":284,"lon":285},40.4165,-3.70256,{"facility":287,"status":8,"city":281,"zip":288,"country":271,"geoPoint":289},"NEXT Oncology - Hospital Quironsalud Madrid","28223",{"lat":284,"lon":285},[291],{"name":292,"role":175,"phone":293,"email":294},"Robert Casper","443-764-9527","rcasper@synnovationtx.com",[],[],[],{"nct_id":4,"conditions":299,"biomarkers":301},[300],"Solid Neoplasm",[],{"nct_id":4,"found":303,"summary":304,"prompt_version":15},true,{"design":305,"status":306,"heading":307,"summary":308,"follow_up":309,"word_count":310,"commitments":311,"compensation":312,"drugs_mentioned":313},"This is an interventional study with a planned enrollment of 400 participants. It is testing different doses of SNV1521, alone or in combination with other drugs.","completed","SNV1521 for Advanced Solid Tumors","This study is testing a new oral medication called SNV1521 for people with advanced solid tumors. Researchers want to see if SNV1521 is safe and well-tolerated, and if it can help treat these cancers. They are also exploring different doses and if SNV1521 can be combined with other treatments like DB-1310, Abiraterone, or Darolutamide. You might be able to join if you have an advanced or metastatic (spread to other parts of the body) solid tumor, a good performance status (ECOG 0 or 1), and a life expectancy of over 3 months. The study aims to enroll 400 participants.","Safety will be monitored from the first dose through the last dose, up to 13 months. Tolerability will be assessed during the first 28-day cycle.",99,"Not specified in the trial record.","Not stated in the trial record.",[30,42,46,51]]