[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543133":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":77,"collaborators":20,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":20,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Ractigen Therapeutics.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RAG-01 dose escalation and dose expansion","EXPERIMENTAL","The starting dose of RAG-01 is 30mg, and there are 4 dose cohorts, including 30mg, 100mg, 300mg, 600mg, respectively. Each eligible subject will be distributed into one cohort. Safety and pharmacokinetics are assessed at each dose level.",[13],"Drug: RAG-01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","RAG-01","RAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Laurence Krieger, MBCHB","GenesisCare, 7 Westbourne Street, St Leonards, NSW 2065, Australia","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Long-Cheng Li","CONTACT","+86 18051622388","lilc@ractigen.com",[33,51,66],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"GenesisCare North Shore","RECRUITING","St Leonards","New South Wales","2065","Australia","AU",{"type":42,"coordinates":43},"Point",[44,45],151.19836,-33.82344,{"lat":45,"lon":44},[48],{"name":23,"role":29,"phone":49,"phoneExt":20,"email":50},"+61 2 8037 4100","laurence_krieger@hotmail.com",{"facility":52,"status":35,"city":53,"state":54,"zip":55,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"The Royal Melbourne Hospital","Melbourne","Victoria","3050",{"type":42,"coordinates":57},[58,59],144.96332,-37.814,{"lat":59,"lon":58},[62],{"name":63,"role":29,"phone":64,"phoneExt":20,"email":65},"Paul Anderson, MBBS FRACS","0393427294","mr.paul.anderson@gmail.com",{"facility":67,"status":35,"city":53,"state":54,"zip":68,"country":39,"countryCode":40,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Peninsula & South Eastern Haematology and Oncology Group","3199",{"type":42,"coordinates":70},[58,59],{"lat":59,"lon":58},[73],{"name":74,"role":29,"phone":75,"phoneExt":20,"email":76},"Sanjeev Sewak, MBBS, ECFMG","0397815244","sewaks01@yahoo.com",{"type":78,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100543133","phase-1-a-study-of-rag-01-in-patients-with-non-muscle-invasive-bladder-cancer-nmibc-who-have-failed-bacillus-calmette-gurin-bcg-therapy-100543133",false,"NCT06351904","A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy","Inclusion Criteria:\n\n1. Ability to understand the study and have signed the informed consent form;\n2. Any adult ≥ 18 years old;\n3. Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;\n4. Expected survival ≥ 6 months;\n5. ECOG PS ≤2;\n6. Sufficient organ functions, as defined below:\n\n   Investigations Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 109\u002FL Hemoglobin: ≥ 90 g\u002FL Platelet: ≥ 100 x 109\u002FL Liver Function Serum bilirubin: ≤ 1.25×ULN or 2.5×ULN（with Gilbert syndrome） AST \\& ALT: ≤ 2.5×ULN Renal Function Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL\u002Fmin\n7. Subject must be able to tolerate catheterization;\n8. Female subject of childbearing potential and her spouse must use adopt effective contraception (non-pharmacological contraception required) from signing informed consent to within 6 months after the last instillation;\n\nExclusion Criteria:\n\n1. Subject who is allergy to RAG-01 or similar products;\n2. Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is shorter from the date of signing ICF;\n3. Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra;\n4. Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable;\n5. The following illnesses have not been relieved to CTCAE 0-1:\n\n   1. Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection;\n   2. Dyspnea;\n   3. Acute and chronic kidney injury, and inflammation;\n   4. Urinary incontinence;\n   5. Urinary frequency;\n   6. Urinary tract obstruction (except benign prostatic hypertrophy);\n6. Subject could not hold the urine for at least 90 mins due to any reason;\n7. New York Heart Association (NYHA) 3 or 4 grade;\n8. Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia;\n9. Subject with QTc \\>470 msec.\n10. Cerebrovascular accidents have not been relieved to CTCAE 0-1;\n11. HIV positive; Active hepatitis B or C. For active HBV, it's defined as HBsAg positive with HBV DNA ≥ ULN, for active HCV, it's defined as HCV antibody positive with HCV RNA ≥ ULN, respectively.\n12. Subject is pregnant or lactating during the treatment period;\n13. History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia;\n14. Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases;\n15. Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he\u002Fshe is not eligible.","ALL","18 Years","75 Years",{"count":90,"type":91},72,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.",[97],"Non-Muscle-Invasive Bladder Cancer (NMIBC)","2025-09-04",{"date":100,"type":101},"2025-09-11","ACTUAL",{"date":103,"type":101},"2024-04-03",{"date":105,"type":91},"2028-08-31",{"name":5,"class":6},3]