[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588624":3},{"organization":4,"armGroups":7,"interventions":58,"overallOfficials":64,"centralContacts":112,"locations":121,"responsibleParty":136,"collaborators":64,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":64,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":64,"studyType":151,"phases":152,"briefSummary":155,"conditions":156,"keywords":64,"overallStatus":124,"whyStopped":64,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,17,22,27,33,38,44,49,53],{"label":9,"type":10,"description":11,"interventionNames":12},"AK129(dose 1) + Chemotherapy(Phase Ib)","EXPERIMENTAL","Non-Squamous NSCLC:Subjects receive AK129 (dose 1) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) plus Pemetrexed until progression.\n\nSquamous NSCLC:Subjects receive AK129 (dose 1) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 1) until progression.",[13,14,15,16],"Drug: AK129(dose 1)","Drug: Pemetrexed","Drug: Paclitaxel","Drug: Carboplatin",{"label":18,"type":10,"description":19,"interventionNames":20},"AK129(dose 2) + Chemotherapy(Phase Ib)","Non-Squamous NSCLC:Subjects receive AK129 (dose 2) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) plus Pemetrexed until progression.\n\nSquamous NSCLC:Subjects receive AK129(dose 2) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(dose 2) until progression.",[14,15,16,21],"Drug: AK129(dose 2)",{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 1 PARTA Treatment Group 1(Phase II)","Non-Squamous NSCLC:Subjects receive AK129 (RP2D) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) plus Pemetrexed until progression.\n\nSquamous NSCLC:Subjects receive AK129(RP2D) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK129(RP2D) until progression.",[14,15,16,26],"Drug: AK129(RP2D)",{"label":28,"type":29,"description":30,"interventionNames":31},"Cohort 1 PARTA Treatment Group 2(Phase II)","ACTIVE_COMPARATOR","Non-Squamous NSCLC:Subjects receive Penpulimab plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab plus Pemetrexed until progression.\n\nSquamous NSCLC:Subjects receive Penpulimab plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab until progression.",[14,15,16,32],"Drug: Penpulimab",{"label":34,"type":10,"description":35,"interventionNames":36},"Cohort 1 PARTB(Phase II)","NSCLC:Subjects receive AK129(RP2D) plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.",[37,26],"Drug: Docetaxel",{"label":39,"type":10,"description":40,"interventionNames":41},"Cohort 2 PARTA(Phase II)","HNSCC:Subjects receive AK129(RP2D,Day1) plus Carboplatin\u002FCis-platinum(Day1) and 5-FU(Day1-4) every 3-week cycle (Q3W) for 6 cycles followed by AK129(RP2D) until progression.",[16,42,43,26],"Drug: Cis-platinum","Drug: 5-FU (5-fluorouracil)",{"label":45,"type":10,"description":46,"interventionNames":47},"Cohort 2 PARTB(Phase II)","HNSCC:Subjects receive AK129(RP2D) plus 1 investigator-selected treatment protocol(Cetuximab\u002FPaclitaxel\u002FDocetaxel) on Day 1 of every 3-week cycle (Q3W) until progression, and are not allowed to choose a treatment they had already received.",[48,15,37,26],"Drug: Cetuximab",{"label":50,"type":10,"description":51,"interventionNames":52},"Cohort 3(Phase II)","CRC:Subjects receive AK129(RP2D) until progression.",[26],{"label":54,"type":10,"description":55,"interventionNames":56},"Cohort 4(Phase II)","Advanced solid tumors:Subjects receive AK129(RP2D)± chemotherapy until progression.",[57,26],"Drug: Chemotherapy",[59,65,69,73,77,80,84,88,92,96,99,102,105,108],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DRUG","AK129(dose 1)","IV infusion",[9],null,{"type":60,"name":66,"description":67,"armGroupLabels":68,"otherNames":64},"Pemetrexed","IV infusion;500mg\u002Fm2",[9,18,23,28],{"type":60,"name":70,"description":71,"armGroupLabels":72,"otherNames":64},"Paclitaxel","IV infusion;175mg\u002Fm2",[9,18,23,28],{"type":60,"name":74,"description":75,"armGroupLabels":76,"otherNames":64},"Carboplatin","IV infusion;AUC 5",[9,18,23,28,39],{"type":60,"name":78,"description":62,"armGroupLabels":79,"otherNames":64},"AK129(dose 2)",[18],{"type":60,"name":81,"description":82,"armGroupLabels":83,"otherNames":64},"Docetaxel","IV infusion;75mg\u002Fm2",[34],{"type":60,"name":85,"description":86,"armGroupLabels":87,"otherNames":64},"Cis-platinum","IV infusion;100 mg\u002Fm2",[39],{"type":60,"name":89,"description":90,"armGroupLabels":91,"otherNames":64},"5-FU (5-fluorouracil)","IV infusion;1000 mg\u002Fm2",[39],{"type":60,"name":93,"description":94,"armGroupLabels":95,"otherNames":64},"Cetuximab","IV infusion;400mg\u002Fm2\u002F 250mg\u002Fm2",[45],{"type":60,"name":70,"description":97,"armGroupLabels":98,"otherNames":64},"IV infusion;80mg\u002Fm2",[45],{"type":60,"name":81,"description":100,"armGroupLabels":101,"otherNames":64},"IV infusion;35mg\u002Fm2",[45],{"type":60,"name":103,"description":62,"armGroupLabels":104,"otherNames":64},"Chemotherapy",[54],{"type":60,"name":106,"description":62,"armGroupLabels":107,"otherNames":64},"AK129(RP2D)",[23,34,39,45,50,54],{"type":60,"name":109,"description":110,"armGroupLabels":111,"otherNames":64},"Penpulimab","IV infusion;200mg",[28],[113,118],{"name":114,"role":115,"phone":116,"phoneExt":64,"email":117},"Wenting Li,M.D.","CONTACT","+86(0760)89873999","clinicaltrials@akesobio.com",{"name":119,"role":115,"phone":64,"phoneExt":64,"email":120},"Hongxu Liu,M.D.","Hongxuliu@qq.com",[122],{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":64},"Liaoning Cancer Hospital","RECRUITING","Shenyang","Liaoning","110801","China","CN",{"type":131,"coordinates":132},"Point",[133,134],123.43278,41.79222,{"lat":134,"lon":133},{"type":137,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100588624","phase-1-ak129-combination-therapy-for-advanced-solid-tumors-100588624",false,"NCT06943820","AK129 Combination Therapy for Advanced Solid Tumors","A Phase Ib\u002FII Study of Anti-PD-1\u002FLAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);\n2. ≥18 years old and ≤ 75 years (regardless of sex);\n3. ECOG performance status 0-1;\n4. Life expectancy longer than 3 months;\n5. 1)Histologically or cytologically confirmed diagnosis of Stage IIIB\u002FC or IV NSCLC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;\n6. 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;\n7. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;\n8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed the presence of small cell carcinoma components\u002FEGFR-sensitive mutations or ALK fusion positivite\u002Fknown ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;\n2. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable\u002Fmismatch repair gene expression defect (MSI-H\u002FdMMR)or histopathological examination confirmed other pathological types;\n3. Participating in another clinical research;\n4. Has known active central nervous system (CNS) metastases, brain stem\u002Fmeningeal metastasis, spinal cord metastasis or compression;\n5. Has an active autoimmune disease that has required systemic treatment in the past 2 years;\n6. Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;\n7. Past or currently has non-infectious pneumonia\u002Finterstitial lung disease that requires systemic glucocorticoid therapy;\n8. Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;\n9. Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;\n10. Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;\n11. Pregnant or lactating female.","ALL","18 Years","75 Years",{"count":149,"type":150},230,"ESTIMATED","INTERVENTIONAL",[153,154],"PHASE1","PHASE2","This is an open, multicenter phase Ib\u002FII clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.",[157,158,159,160],"Non-small Cell Lung Cancer Stage IIIB\u002FIV","Head and Neck Squamous Cell Carcinoma (HNSCC)","Colorectal Adenocarcinoma","Advanced Solid Tumors","2025-05-28",{"date":163,"type":164},"2025-06-03","ACTUAL",{"date":166,"type":164},"2025-05-21",{"date":168,"type":150},"2028-05",{"name":5,"class":6},1]