[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551599":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":149,"collaborators":28,"id":151,"slug":28,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":28,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":28,"enrollmentInfo":159,"targetDuration":28,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"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",[36,54,64,74,83,89,99,114,124,135],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Dana-Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215","United States",{"type":44,"coordinates":45},"Point",[46,47],-71.05977,42.35843,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":28,"email":53},"Kailene Sullivan","617-632-3482","kailene_sullivan@dfci.harvard.edu",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":28},"University of Michigan","Ann Arbor","Michigan","48109",{"type":44,"coordinates":60},[61,62],-83.74088,42.27756,{"lat":62,"lon":61},{"facility":65,"status":38,"city":66,"state":67,"zip":68,"country":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":28},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":44,"coordinates":70},[71,72],-90.19789,38.62727,{"lat":72,"lon":71},{"facility":75,"status":38,"city":76,"state":76,"zip":77,"country":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":28},"Laura & Isaac Perlmutter Cancer Center at NYU Langone Health","New York","10016",{"type":44,"coordinates":79},[80,81],-74.00597,40.71427,{"lat":81,"lon":80},{"facility":84,"status":38,"city":76,"state":76,"zip":85,"country":42,"cosmosGeoPoint":86,"geoPoint":88,"contacts":28},"Memorial Sloan Kettering Cancer Center","10065",{"type":44,"coordinates":87},[80,81],{"lat":81,"lon":80},{"facility":90,"status":38,"city":91,"state":92,"zip":93,"country":42,"cosmosGeoPoint":94,"geoPoint":98,"contacts":28},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":44,"coordinates":95},[96,97],-95.36327,29.76328,{"lat":97,"lon":96},{"facility":100,"status":38,"city":101,"state":102,"zip":103,"country":42,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Next Oncology VA","Fairfax","Virginia","22031",{"type":44,"coordinates":105},[106,107],-77.30637,38.84622,{"lat":107,"lon":106},[110],{"name":111,"role":32,"phone":112,"phoneExt":28,"email":113},"Carrie Friedman, RN, BSN, OCN","703-636-1473","carrie.friedman@usoncology.com",{"facility":115,"status":38,"city":116,"state":117,"zip":118,"country":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":28},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":44,"coordinates":120},[121,122],-122.33207,47.60621,{"lat":122,"lon":121},{"facility":125,"status":38,"city":126,"state":127,"zip":128,"country":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":28},"Ottawa Hospital Cancer Centre","Ottawa","Ontario","K1H 8L6","Canada",{"type":44,"coordinates":131},[132,133],-75.69812,45.41117,{"lat":133,"lon":132},{"facility":136,"status":38,"city":137,"state":127,"zip":138,"country":129,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Princess Margaret Cancer Center","Toronto","M5G 2M9",{"type":44,"coordinates":140},[141,142],-79.39864,43.70643,{"lat":142,"lon":141},[145],{"name":146,"role":32,"phone":147,"phoneExt":148,"email":28},"Enrique Sanz Garcia","416-946-4501","3617",{"type":150,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","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":160,"type":161},105,"ESTIMATED","INTERVENTIONAL",[164],"PHASE1","Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC",[167,168],"Adenoid Cystic Carcinoma","Colorectal Cancer","2025-11-12",{"date":171,"type":172},"2025-11-14","ACTUAL",{"date":174,"type":172},"2024-08-19",{"date":176,"type":161},"2027-06",{"name":5,"class":6},10]