[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aston Sci. Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100498540","phase-2-therapeutic-cancer-vaccine-ast-301-pngvl3-hicd-in-gastric-cancer-100498540",false,"NCT05771584","Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer","A Phase 2 Study to Evaluate the Safety and Immunological Efficacy of Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Expressing Gastric Cancer (CORNERSTONE-003)","Conerstone3","Key Inclusion Criteria:\n\n* Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment\n* Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC)\n* HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)\u002FAmerican Society for Clinical Pathology (ASCP)\u002FAmerican Society of Clinical Oncology (ASCO) guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Demonstrates adequate organ function.\n\nKey Exclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhuGM-CSF\n* Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease.\n* Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP).\n* Has a history of autoimmune disease or inflammatory disease\n* Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children","ALL","18 Years","85 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this early proof-of-concept study to evaluate the safety and immunologic efficacy of AST-301 in gastric cancer patients with HER2 expression (including both HER2 low expression and overexpression) who have completed the standard adjuvant treatment (including those who discontinued the standard adjuvant treatment due to intolerance).\n\nParticipants will be randomized 1:1 to either Arm 1 (Q3W, 3 cycles), or Arm 2 (Q3W, 6 cycles) of the study.\n\nSafety Monitoring Committee (SMC) will oversee safety of study at 25% (6 participants), 50% (12 participants), and 75% (18 participants) of participants receive at least 1 dose of AST-301 and survival follow up will be performed to determine disease-free survival (DFS).",[28],"Gastric Cancer","RECRUITING","2024-07-08",{"date":32,"type":33},"2024-07-10","ACTUAL",{"date":35,"type":33},"2023-07-04",{"date":37,"type":22},"2026-06-15",{"name":39,"class":40},"Aston Sci. Inc.","INDUSTRY",6,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100500315","phase-2-adjuvant-therapeutic-cancer-vaccine-ast-201-pumvc3-higfbp-2-in-patients-with-advanced-ovarian-cancer-100500315","NCT05794659","Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer","A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)","Cornerstone4","Inclusion Criteria:\n\n* Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer\n* Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)\n* Can start adjuvant therapy within 6 weeks of debulking surgery\n* Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhuGM-CSF\n* Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease\n* Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs\n* Has active or prior autoimmune disease or inflammatory disease\n* Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study",{"count":51,"type":22},98,[25],"The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel\u002FCarboplatin).",[55],"Advanced Ovarian Cancer",[57,58,59,60],"cancer vaccine","phase 2 study","Advanced ovarian cancer","homologous-recombination proficient (HRP)","NOT_YET_RECRUITING","2023-07-18",{"date":64,"type":33},"2023-07-20",{"date":66,"type":22},"2023-11-15",{"date":68,"type":22},"2027-11-15",{"name":39,"class":40},1,""]