[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641312":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":43,"locations":42,"responsibleParty":49,"collaborators":42,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":42,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":42,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":42,"overallStatus":71,"whyStopped":42,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":42},{"fullName":5,"class":6},"Jiangxi Kvvit Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"DN022150+AG( Stage I ）","EXPERIMENTAL","Stage I，To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data. After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen",[13],"Drug: DN022150+AG( Stage I ）",{"label":15,"type":10,"description":16,"interventionNames":17},"DN022150+AG（ Stage II）","Stage II DN022150（ RP3D)+AG",[18],"Drug: DN022150+AG（Stage II）",{"label":20,"type":21,"description":22,"interventionNames":23},"DN022150 placebo+AG（ Stage II）","PLACEBO_COMPARATOR","Stage II DN022150 placebo+AG",[24],"Drug: placebo+AG（Stage II）",[26,32,37],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","28-day \u002Fcycle",[9],[31],"Dose-finding group",{"type":27,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"DN022150+AG（Stage II）",[15],[36],"Test group",{"type":27,"name":38,"description":28,"armGroupLabels":39,"otherNames":40},"placebo+AG（Stage II）",[20],[41],"Control group",null,[44],{"name":45,"role":46,"phone":47,"phoneExt":42,"email":48},"Man Xu","CONTACT","+86 19979703650","xuman@kvvit.com",{"type":50,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100641312","phase-2-clinical-trial-of-dn022150-combined-with-ag-chemotherapy-as-first-line-treatment-for-locally-advanced-or-metastatic-pancreatic-cancer-with-kras-g12d-mutation-100641312",false,"NCT07656376","Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form\n2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent\n3. Life expectancy ≥ 12 weeks\n4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer\n5. ECOG score of performance status 0 \\~ 1\n6. At least one measurable lesion by RECIST v1.1 criteria\n7. Adequate organ function\n8. Effective methods of contraception during the study\n\nExclusion Criteria:\n\n1. Progression or other malignancy requiring treatment within 5 years prior to enrollment\n2. Prior targeted therapy for KRAS G12D\n3. With central nervous system metastasis\n4. Uncontrolled fluid accumulation\n5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment\n6. Concomitant clinically significant cardiovascular disease\n7. Concurrent major acute or chronic infectious disease\n8. 4\\. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;\n9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse\n10. Other situations not suitable for the study judged by the investigator","ALL","18 Years","75 Years",{"count":61,"type":62},465,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE2","PHASE3","This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I ：explores the combination dose and the second phase; Stage II ：patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.",[69,70],"Pancreatic Cancer","Pancreatic Carcinoma","NOT_YET_RECRUITING","2026-06-15",{"date":74,"type":75},"2026-06-18","ACTUAL",{"date":77,"type":62},"2027-06-06",{"date":79,"type":62},"2029-05-08",{"name":5,"class":6}]