[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476792":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":140,"collaborators":38,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":38,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":38,"enrollmentInfo":151,"targetDuration":38,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":38,"overallStatus":43,"whyStopped":38,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Epigenetix, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1","EXPERIMENTAL","Patients will be assigned escalated dose according to BOIN design. The starting dose is 5 mg orally once a day for 7 consecutive days followed by 14 days of rest.",[13],"Drug: EP31670",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2","Patients will be assigned escalated dose according to BOIN design. The starting dose is 20 mg orally once a day for 14 consecutive days followed by 14 days of rest.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 3","Patients will be assigned escalated dose according to BOIN design. The starting dose is 10 mg orally once a day for 14 consecutive days in combination with ruxolitinib or momelotinib followed by 14 days of rest according to the traditional 3 + 3 design by the modified Fibonacci sequence",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","EP31670","EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP\u002Fp300 inhibitor.",[9,15,19],[29],"NEO2734",[31],{"name":32,"affiliation":5,"role":33},"Judy Chiao, MD","STUDY_DIRECTOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","(561) 865-6098",null,"studies@epigenetix.com",[41,62,76,93,107,124],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Mayo Clinic Arizona","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-112.07404,33.44838,{"lat":53,"lon":52},[56,59],{"name":57,"role":36,"phone":58,"phoneExt":38,"email":38},"Clinical Trials Referral Office","855-776-0015",{"name":60,"role":61,"phone":38,"phoneExt":38,"email":38},"Jeanne Palmer, MD","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":43,"city":64,"state":65,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"type":50,"coordinates":68},[69,70],-81.65565,30.33218,{"lat":70,"lon":69},[73,74],{"name":57,"role":36,"phone":58,"phoneExt":38,"email":38},{"name":75,"role":61,"phone":38,"phoneExt":38,"email":38},"James Foran, MD",{"facility":77,"status":43,"city":78,"state":79,"zip":80,"country":47,"countryCode":48,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":50,"coordinates":82},[83,84],-71.05977,42.35843,{"lat":84,"lon":83},[87,90,92],{"name":88,"role":36,"phone":89,"phoneExt":38,"email":38},"Atish Choudhury, MD","877-442-3324",{"name":91,"role":36,"phone":89,"phoneExt":38,"email":38},"Jia Luo, MD",{"name":88,"role":61,"phone":38,"phoneExt":38,"email":38},{"facility":94,"status":43,"city":95,"state":96,"zip":97,"country":47,"countryCode":48,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"type":50,"coordinates":99},[100,101],-92.4699,44.02163,{"lat":101,"lon":100},[104,105],{"name":57,"role":36,"phone":58,"phoneExt":38,"email":38},{"name":106,"role":61,"phone":38,"phoneExt":38,"email":38},"Mrinal Patnaik, MD",{"facility":108,"status":43,"city":109,"state":110,"zip":111,"country":47,"countryCode":48,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":50,"coordinates":113},[114,115],-95.36327,29.76328,{"lat":115,"lon":114},[118,122],{"name":119,"role":36,"phone":120,"phoneExt":38,"email":121},"Rabia Khan","713-563-4667","RKhan@MDAnderson.org",{"name":123,"role":61,"phone":38,"phoneExt":38,"email":38},"Sarina A Piha-Paul, MD",{"facility":125,"status":43,"city":126,"state":127,"zip":128,"country":47,"countryCode":48,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"University of Washington\u002FFred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":50,"coordinates":130},[131,132],-122.33207,47.60621,{"lat":132,"lon":131},[135,138],{"name":136,"role":36,"phone":38,"phoneExt":38,"email":137},"Harini Ramachandran","phase1clinicaltrial@seattlecca.org",{"name":139,"role":61,"phone":38,"phoneExt":38,"email":38},"Michael Schweizer, MD",{"type":141,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100476792","phase-1-dual-bet-and-cbpp300-inhibitor-in-patients-with-targeted-advanced-solid-tumors-and-hematological-malignancies-100476792",false,"NCT05488548","Dual BET and CBP\u002Fp300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies","A Phase 1 Study of EP31670, a Dual BET and CBP\u002Fp300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Relapse or refractory castration-resistant prostate cancer (CRPC) following at least one anti-androgen regimen and a docetaxel-containing regimen OR\n* metastatic or unresectable NUT midline carcinoma for which standard curative or palliative measures do not exist; OR\n\nPart 2\n\n* relapsed or refractory CMML following at least 4 cycles of hypomethylating agent-containing regimen or hydroxyurea unless demonstration of progression or intolerance;\n* advanced MF (intermediate or high-risk) following at least one JAK inhibitor-containing regimen or unsuitable candidates for JAK inhibitor treatments.\n\nPart 3: advanced MF (intermediate or high-risk) with ≤10% blasts in peripheral blood who have not achieved an adequate response or have lost the response to a JAK inhibitor-containing regimen after being on treatment for at least 3 months.\n\nPatients who have other types of relapsed or refractory solid tumors (Part 1) or hematological malignancies (Part 2) with pathological and\u002For biological features suggesting a potential benefit from dual BET and CBP\u002Fp300 inhibition may be enrolled after discussion with and approval from medical monitor and sponsor.\n\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 Life expectancy ≥ 3 months Evaluable disease\n\nAdequate bone marrow function:\n\n* Hemoglobin ≥ 9.0 g\u002FdL (Part 1)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FdL (Part 1)\n* Platelet count ≥100,000\u002FμL (Part 1) or ≥75,000\u002FμL (Part 3)\n\nAdequate renal function: Creatinine clearance (CLcr) ≥ 60 mL\u002Fmin\n\nAdequate liver function: total bilirubin ≤ 1.5 x ULN; alanine aminotransferase (ALT) or aspartate Aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases\n\nInternal normalized ratio for prothrombin time (INR) ≤ 1.2 in patients not receiving chronic anticoagulation\n\nFour weeks from prior anti-cancer therapy including chemotherapy, immunotherapy, investigational anti-cancer therapy or 5 half-lives from targeted agents, radiation and have recovered from prior treatment toxicities to grade 1 or less.\n\nFour weeks from major surgery.\n\nFor fertile men and women, agreement to use effective contraceptive methods duration of study participation and 4 weeks after the last dose of study drug.\n\nAbility to understand and willingness to sign the informed consent form.\n\nExclusion Criteria:\n\n* New and progressive central nervous system (CNS) metastasis; patients with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after CNS-directed therapy shows no evidence of progression and the patient is neurologically stable\n* Corrected QT interval ≥470 msec\n* Uncontrolled concurrent illnesses including, but not limited to, ongoing active infection requiring intravenous antibiotics or antifungal agents, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness\u002Fsocial situations that would affect compliance with study requirements; patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of EP31670 are eligible for this trial\n* Pregnant or lactating women\n* Known history of hepatitis B, hepatitis C requiring antiviral treatment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial","ALL","18 Years",{"count":152,"type":153},75,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","A Phase 1, first-in-human study of EP31670, a dual BET and CBP\u002Fp300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies",[159,160,161,162],"Castrate Resistant Prostate Cancer","NUT Carcinoma","Chronic Myelomonocytic Leukemia","Myelofibrosis","2025-01-12",{"date":165,"type":166},"2025-01-14","ACTUAL",{"date":168,"type":166},"2022-12-21",{"date":170,"type":153},"2025-05",{"name":5,"class":6},6]