[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rgenta Therapeutics Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},105,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC",[26,27],"Adenoid Cystic Carcinoma","Colorectal Cancer","RECRUITING","2025-11-12",{"date":31,"type":32},"2025-11-14","ACTUAL",{"date":34,"type":32},"2024-08-19",{"date":36,"type":20},"2027-06",{"name":38,"class":39},"Rgenta Therapeutics Inc","INDUSTRY",10,""]