[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645104":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":64,"locations":74,"responsibleParty":120,"collaborators":35,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":35,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":35,"enrollmentInfo":131,"targetDuration":35,"studyType":134,"phases":135,"briefSummary":126,"conditions":138,"keywords":142,"overallStatus":145,"whyStopped":35,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Genfleet Therapeutics (Shanghai) Inc.","INDUSTRY",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: GFH276 + Cetuximab","EXPERIMENTAL","GFH276 once daily; cetuximab 500 mg\u002Fm² intravenous infusion every 2 weeks.",[13,14],"Drug: GFH276","Drug: Cetuximab",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm B: GFH276 + AG","GFH276 once daily; nab-paclitaxel 125 mg\u002Fm² + gemcitabine 1000 mg\u002Fm² (AG regimen); 4-week cycle (D1, D8, D15) or 3-week cycle (D1, D8) in China",[13,19,20],"Drug: Nab paclitaxel","Drug: Gemcitabine",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm C: GFH276 + mFOLFIRINOX","GFH276 once daily; mFOLFIRINOX :Fluorouracil 2400 mg\u002Fm²(46 h), Leucovorin 400 mg\u002Fm², Irinotecan 150 mg\u002Fm², Oxaliplatin 85 mg\u002Fm², IV D1, every 2 weeks .\n\nThe mFOLFIRINOX regimen may be administered per the above dosage, or in accordance with national or institutional guidelines.",[13,25,26,27,28],"Drug: Fluorouracil","Drug: Leucovorin","Drug: Irinotecan","Drug: Oxaliplatin",[30,36,40,44,48,52,56,60],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","GFH276","Oral GFH276 administered once daily in combination with other study drugs.",[9,16,22],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Cetuximab","Intravenous cetuximab at a dose of 500 mg\u002Fm²",[9],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Nab paclitaxel","Intravenous nab-paclitaxel at a dose of 125 mg\u002Fm².",[16],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Gemcitabine","Intravenous Gemcitabine at a dose of 1000 mg\u002Fm².",[16],{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":35},"Fluorouracil","Intravenous Fluorouracil at a dose of 2400 mg\u002Fm² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.",[22],{"type":31,"name":53,"description":54,"armGroupLabels":55,"otherNames":35},"Leucovorin","Intravenous leucovorin at a dose of 400 mg\u002Fm².Dosing may follow the above regimen or local institutional standards.",[22],{"type":31,"name":57,"description":58,"armGroupLabels":59,"otherNames":35},"Irinotecan","Intravenous irinotecan at a dose of 150 mg\u002Fm².Dosing may follow the above regimen or local institutional standards.",[22],{"type":31,"name":61,"description":62,"armGroupLabels":63,"otherNames":35},"Oxaliplatin","Intravenous oxaliplatin at a dose of 85 mg\u002Fm².Dosing may follow the above regimen or local institutional standards.",[22],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":35,"email":69},"Bai Li","CONTACT","18201333260","lbai@genfleet.com",{"name":71,"role":67,"phone":72,"phoneExt":35,"email":73},"Zhang Pingping","18758558734","ppzhang@genfleet.com",[75,93,103],{"facility":76,"status":35,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Macquarie University \u002F Clinical Trials Unit","North Ryde","New South Wales","2109","Australia","AU",{"type":83,"coordinates":84},"Point",[85,86],151.12436,-33.79677,{"lat":86,"lon":85},[89,91],{"name":90,"role":67,"phone":35,"phoneExt":35,"email":35},"Andrew Parsonson, PhD",{"name":92,"role":67,"phone":35,"phoneExt":35,"email":35},"PhD",{"facility":94,"status":35,"city":95,"state":96,"zip":97,"country":80,"countryCode":81,"cosmosGeoPoint":98,"geoPoint":102,"contacts":35},"Monash Health (Monash Medical Centre)","Clayton","Victoria","3168",{"type":83,"coordinates":99},[100,101],145.11667,-37.91667,{"lat":101,"lon":100},{"facility":104,"status":35,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":83,"coordinates":111},[112,113],121.45806,31.22222,{"lat":113,"lon":112},[116],{"name":117,"role":67,"phone":118,"phoneExt":35,"email":119},"Xianjun Yu, MD","13801669875","yuxianjun@fudanpci.org",{"type":121,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100645104","phase-1-a-study-of-gfh276-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-and-pancreatic-ductal-adenocarcinoma-pdac-harboring-ras-mutation-100645104",false,"NCT07678593","A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","A Multi-center, Open-label Phase Ib\u002FII Study Exploring the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification\n3. At least one measurable lesion according to RECIST v1.1\n4. ECOG performance status 0 or 1\n5. Life expectancy \\> 3 months\n6. Adequate organ function\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.\n5. With active infection (HIV, HBV, HCV, syphilis)\n6. The presence of clinical or radiological evidence of intestinal obstruction.\n7. Prior anticancer therapy within 28 days or 5 half-lives\n8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months\n9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n10. History of central nervous system (CNS)disease\n11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.","ALL","18 Years",{"count":132,"type":133},222,"ESTIMATED","INTERVENTIONAL",[136,137],"PHASE1","PHASE2",[139,140,141],"Advanced Solid Tumors Cancer","Pancreatic Ductal Adenocarcinoma","RAS Mutation",[32,143,141,144],"PDAC","solid tumors","NOT_YET_RECRUITING","2026-06-24",{"date":148,"type":149},"2026-07-01","ACTUAL",{"date":151,"type":133},"2026-09",{"date":153,"type":133},"2028-09",{"name":5,"class":6},3]