[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603040":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":30,"responsibleParty":32,"collaborators":35,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":30,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":30,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":72,"whyStopped":30,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":30},{"fullName":5,"class":6},"National Cancer Center, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm: Iparomlimab and Tuvonralimab Combined with Chemotherapy","EXPERIMENTAL","Patients will receive Iparomlimab and Tuvonralimab (5 mg\u002Fkg) plus chemotherapy (pemetrexed and platinum drugs) every 3 weeks for 4-6 cycles, followed by maintenance therapy with Iparomlimab and Tuvonralimab for up to 2 years.",[13],"Drug: iparomlimab and tuvonralimab (Dual PD-1\u002FCTLA-4 blockade) + chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","iparomlimab and tuvonralimab (Dual PD-1\u002FCTLA-4 blockade) + chemotherapy","Novel Bispecific Checkpoint Inhibition:\n\nQL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions.\n\nChemotherapy for first-line treatment (pemetrexed plus cisplatin or carboplatin )\n\nChemotherapy for second-line treatment (pemetrexed, gemcitabine or vinorelbine)",[9],[21],"QL1706+chemotherapy",[23],{"name":24,"affiliation":5,"role":25},"Puyuan Xing, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","8618611417207",null,"xingpuyuan@cicams.ac.cn",{"type":25,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Puyuan Xing","Department of Medical Oncology, National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College",[36,39,42,44,46],{"name":37,"class":38},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"name":40,"class":41},"Affiliated Cancer Hospital of Zhengzhou University","UNKNOWN",{"name":43,"class":6},"Beijing Chest Hospital, Capital Medical University",{"name":45,"class":6},"The Affiliated Hospital of Inner Mongolia Medical University",{"name":47,"class":6},"Shaanxi Provincial Cancer Hospital","100603040","phase-1-study-of-iparomlimab-and-tuvonralimab-plus-chemotherapy-in-malignant-mesothelioma-100603040",false,"NCT07131345","Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma","A Single-Arm, Multicenter, Open-Label Phase Ib\u002FII Clinical Study Exploring the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy for the Treatment of Malignant Mesothelioma","Inclusion Criteria:\n\n* Subjects must provide informed consent prior to initiating any study-specific procedures.\n* Male or female subjects aged ≥18 and ≤75 years.\n* Histologically\u002Fcytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).\n* Subjects with MM unsuitable for radical resection and\u002For radiotherapy per AJCC 8th Edition.\n* Subjects who received neoadjuvant\u002Fadjuvant chemotherapy for radical surgery completed \\>6 months prior to current recurrent disease diagnosis, not counted in subsequent treatment lines.\n* Prior systemic anti-tumor therapy requirements:\n\n  * Safety run-in phase: ≥1 prior anti-tumor therapy line (maximum 3 lines)\n  * Phase II first-line cohort: No prior systemic anti-tumor therapy\n  * Phase II second-line cohort: Only 1 prior systemic anti-tumor therapy line\n* ECOG performance status 0-2.\n* Investigator-assessed life expectancy \\>3 months.\n* Adequate hematological parameters.\n\nExclusion Criteria:\n\n* Prior CTLA-4 inhibitors prohibited; prior PD-1\u002FPD-L1 allowed unless discontinued for immune toxicity\n* Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)\n* Significant cardiovascular history within 6 months","ALL","18 Years","75 Years",{"count":59,"type":60},55,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option.\n\nStudy Design:\n\nPhase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II.\n\nPhase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.",[67,68],"Malignant Mesothelioma","Mesothelioma",[67,70,71],"iparomlimab and tuvonralimab","immunotherapy","NOT_YET_RECRUITING","2025-08-19",{"date":75,"type":76},"2025-08-20","ACTUAL",{"date":78,"type":60},"2025-09-01",{"date":80,"type":60},"2027-07-01",{"name":5,"class":6}]