[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551599":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":151,"collaborators":28,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":28,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":28,"enrollmentInfo":162,"targetDuration":28,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Rgenta Therapeutics Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation","EXPERIMENTAL","RGT-61159 in escalating doses",[13],"Drug: RGT-61159",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose expansion Cohort A","Dose optimization; RGT-61159, 2 doses, randomized allocation",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose expansion Cohort B","Simon's 2 stage, RGT-61150 at optimized dose from Part A",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","RGT-61159","Oral MYB inhibitor",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Clinical Operations","CONTACT","857-225-2840","Clinical-Operations@rgentatx.com",[36,55,65,75,84,90,100,115,125,137],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Dana-Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.05977,42.35843,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":28,"email":54},"Kailene Sullivan","617-632-3482","kailene_sullivan@dfci.harvard.edu",{"facility":56,"status":38,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":28},"University of Michigan","Ann Arbor","Michigan","48109",{"type":45,"coordinates":61},[62,63],-83.74088,42.27756,{"lat":63,"lon":62},{"facility":66,"status":38,"city":67,"state":68,"zip":69,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":74,"contacts":28},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":45,"coordinates":71},[72,73],-90.19789,38.62727,{"lat":73,"lon":72},{"facility":76,"status":38,"city":77,"state":77,"zip":78,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":28},"Laura & Isaac Perlmutter Cancer Center at NYU Langone Health","New York","10016",{"type":45,"coordinates":80},[81,82],-74.00597,40.71427,{"lat":82,"lon":81},{"facility":85,"status":38,"city":77,"state":77,"zip":86,"country":42,"countryCode":43,"cosmosGeoPoint":87,"geoPoint":89,"contacts":28},"Memorial Sloan Kettering Cancer Center","10065",{"type":45,"coordinates":88},[81,82],{"lat":82,"lon":81},{"facility":91,"status":38,"city":92,"state":93,"zip":94,"country":42,"countryCode":43,"cosmosGeoPoint":95,"geoPoint":99,"contacts":28},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":45,"coordinates":96},[97,98],-95.36327,29.76328,{"lat":98,"lon":97},{"facility":101,"status":38,"city":102,"state":103,"zip":104,"country":42,"countryCode":43,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Next Oncology VA","Fairfax","Virginia","22031",{"type":45,"coordinates":106},[107,108],-77.30637,38.84622,{"lat":108,"lon":107},[111],{"name":112,"role":32,"phone":113,"phoneExt":28,"email":114},"Carrie Friedman, RN, BSN, OCN","703-636-1473","carrie.friedman@usoncology.com",{"facility":116,"status":38,"city":117,"state":118,"zip":119,"country":42,"countryCode":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":28},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":45,"coordinates":121},[122,123],-122.33207,47.60621,{"lat":123,"lon":122},{"facility":126,"status":38,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":28},"Ottawa Hospital Cancer Centre","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":45,"coordinates":133},[134,135],-75.69812,45.41117,{"lat":135,"lon":134},{"facility":138,"status":38,"city":139,"state":128,"zip":140,"country":130,"countryCode":131,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Princess Margaret Cancer Center","Toronto","M5G 2M9",{"type":45,"coordinates":142},[143,144],-79.39864,43.70643,{"lat":144,"lon":143},[147],{"name":148,"role":32,"phone":149,"phoneExt":150,"email":28},"Enrique Sanz Garcia","416-946-4501","3617",{"type":152,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100551599","phase-1-study-of-safety-and-efficacy-of-rgt-61159-in-adults-with-relapsedrefractory-adenoid-cystic-carcinoma-acc-or-colorectal-carcinoma-crc-100551599",false,"NCT06462183","Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed\u002FRefractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)","A Phase 1a\u002F1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed\u002FRefractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)","Inclusion Criteria:\n\n* Histologically confirmed ACC or CRC\n* Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation\n* Patients with locally relapsed\u002Frefractory (R\u002FR) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry\n* Patients with CRC must have locally R\u002FR advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.\n* Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Resolved acute effects of any prior therapy to baseline\n\nExclusion Criteria:\n\n* Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1\n* Chemotherapy within 14 days prior to Cycle 1 Day 1\n* Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1\n* Radiation therapy within 21 days prior to Cycle 1 Day 1\n* Investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1\n* Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment\n* Active known second malignancy\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2 unless it's well-controlled HIV (eg, cluster of differentiation 4 \\[CD4\\] \\> 350\u002Fmm3 and undetectable viral load)\n* Current active liver disease including hepatitis A (hepatitis A \\[HepA\\] virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA)\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* Treatment with a long-acting hematopoietic growth factor within 14 days before Cycle 1 Day 1 or a short-acting hematopoietic growth factor within 7 days before Cycle 1 Day 1\n* Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days before Cycle 1 Day 1\n* Patients with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroid throughout this indication for at least 4 weeks before starting treatment in this study\n* History of solid organ transplantation\n* Coronavirus disease 2019 (COVID-19) vaccination within 14 days prior to first dose of study drug\n* Prior treatment with a MYB inhibitor","ALL","18 Years",{"count":163,"type":164},105,"ESTIMATED","INTERVENTIONAL",[167],"PHASE1","Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC",[170,171],"Adenoid Cystic Carcinoma","Colorectal Cancer","2025-11-12",{"date":174,"type":175},"2025-11-14","ACTUAL",{"date":177,"type":175},"2024-08-19",{"date":179,"type":164},"2027-06",{"name":5,"class":6},10]