[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536106":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":112,"collaborators":19,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":19,"enrollmentInfo":124,"targetDuration":19,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Aprea Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"APR-1051","EXPERIMENTAL","Dose Escalation based on BOIN Design",[13],"Drug: APR-1051",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","WEE1 Inhibitor",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Senior Medical Advisor","CONTACT","215-948-4119","info@aprea.com",[27,50,63,79,95],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"MD Anderson Cancer Center (MDACC)","RECRUITING","Houston","Texas","77030","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-95.36327,29.76328,{"lat":39,"lon":38},[42,44,47],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},"Jessica Rhudy",{"name":19,"role":23,"phone":45,"phoneExt":19,"email":46},"713-745-5474","jrhudy@mdanderson.org",{"name":48,"role":49,"phone":19,"phoneExt":19,"email":19},"Timothy Yap, 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FRCPC",{"type":113,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100536106","phase-1-study-of-apr-1051-in-patients-with-advanced-solid-tumors-100536106",false,"NCT06260514","Study of APR-1051 in Patients With Advanced Solid Tumors","A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors","ACESOT-1051","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of advanced\u002Fmetastatic solid tumor\n* Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%\n* Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation\n* Adequate bone marrow and organ function\n* Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry\n\nExclusion Criteria:\n\n* Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1\n* Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs\n* Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051\n* Major surgery within 21 days prior to Day 1\n* Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy","ALL","18 Years",{"count":125,"type":126},90,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.",[132],"Advanced Solid Tumor","2026-08-14",{"date":135,"type":136},"2026-08-17","ACTUAL",{"date":138,"type":136},"2024-06-13",{"date":140,"type":126},"2028-06",{"name":5,"class":6},5]