[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610593":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":40,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":40,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":40,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":40,"overallStatus":60,"whyStopped":40,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Minghui Pharmaceutical (Hangzhou) Ltd","INDUSTRY",[8,15,20,25,28,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation: cohort 1","EXPERIMENTAL","Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration.",[13,14],"Drug: MHB036C for Injection","Drug: Furmonertinib",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose escalation: cohort 2","Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration",[13,19],"Drug: MHB039A for Injection",{"label":21,"type":10,"description":22,"interventionNames":23},"Dose escalation: cohort 3","Subjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg\u002FmL\u002Fmin by intravenous administration",[13,24],"Drug: Carboplatin",{"label":26,"type":10,"description":11,"interventionNames":27},"Dose expansion: cohort 4",[13,14],{"label":29,"type":10,"description":17,"interventionNames":30},"Dose expansion: cohort 5",[13,19],{"label":32,"type":10,"description":22,"interventionNames":33},"Dose expansion: cohort 6",[13,24],[35,41,44,48],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","MHB036C for Injection","IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.",[9,16,21,26,29,32],null,{"type":36,"name":42,"description":38,"armGroupLabels":43,"otherNames":40},"MHB039A for Injection",[16,29],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":40},"Furmonertinib","Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.",[9,26],{"type":36,"name":49,"description":38,"armGroupLabels":50,"otherNames":40},"Carboplatin",[21,32],[52],{"name":53,"role":54,"phone":55,"phoneExt":40,"email":56},"CMO\u002F Senior Vice President of R&D","CONTACT","86 0571-86963293","jwshi@minghuipharma.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":40,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Shanghai Chest Hospital","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":66,"coordinates":67},"Point",[68,69],121.45806,31.22222,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":74,"phoneExt":40,"email":75},"Ethics Committee","+86 021-22200000-5341","chestgcp@126.com",{"type":77,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100610593","phase-1-a-study-of-mhb036c-combined-with-anti-tumor-therapies-in-patients-with-advanced-lung-cancer-100610593",false,"NCT07229599","A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer","A Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years and≤75 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and\u002For radical concurrent\u002Fsequential radiotherapy and chemotherapy.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate bone marrow reserve and organ function.\n9. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.\n\n   \\-\n\nExclusion Criteria:\n\n1. Small cell lung cancer (SCLC) components in the histopathology.\n2. History of ≥2 primary malignancies within 5 years prior to informed consent.\n3. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n4. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n5. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n6. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.\n7. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.\n8. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.\n9. Vaccinated within 4 weeks before dosing.\n10. Treated with systemic corticosteroids within 14 days before dosing.\n11. Severe impairment of pulmonary function; interstitial lung disease or a history of pneumonia requiring steroid treatment; previous left or right pneumonectomy.\n12. Active systemic infection requiring treatment within 7 days before dosing.\n13. Uncontrolled third-space effusion.\n14. Serious cardiovascular or cerebrovascular diseases.\n15. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n16. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n17. Known alcohol or drug dependence.\n18. Pregnant or breastfeeding women, or individuals planning to conceive. -","ALL","18 Years","75 Years",{"count":89,"type":90},300,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.",[97],"Advanced Lung Cancer","2025-11-13",{"date":100,"type":101},"2025-11-17","ACTUAL",{"date":103,"type":101},"2025-05-09",{"date":105,"type":90},"2030-05",{"name":5,"class":6},1]