[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Minghui Pharmaceutical (Hangzhou) Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":283},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,40,56,75,100,118,133,150,167,186,207,224,245,264],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100637377","phase-3-treatment-of-active-thyroid-eye-disease-with-mhb018a-in-a-randomized-placebo-controlled-study-100637377",false,"NCT07622108","Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study","A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Active Moderate to Severe Thyroid Eye Disease.","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye\u002Ftarget eye at screening and baseline must be ≥3 points (7-point scale).\n4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.\n4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.\n6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops\u002Fointments for TED within 4 weeks before the first dose; subjects who received periorbital\u002Forbital steroid injections within 3 months before the first dose.\n7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).\n8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.\n9. Previous treatment targeting IGF-1R.\n10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed.\n11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.\n12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.\n13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal\u002Fsquamous cell carcinoma of the skin).\n14. Acute cardiovascular disease history or treatment within 6 months before the first dose.\n15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n16. Pregnant or lactating women.\n17. Drug or alcohol abuse during the screening period.\n18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.\n19. Biopsy-proven or clinically suspected inflammatory bowel disease.\n20. Positive results for serum virology tests (defined as pos\n21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.\n22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.\n23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.","ALL","18 Years","75 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED.",[27],"Thyroid Eye Disease, TED","NOT_YET_RECRUITING","2026-06-02",{"date":31,"type":32},"2026-06-04","ACTUAL",{"date":34,"type":21},"2026-12",{"date":36,"type":21},"2029-07",{"name":38,"class":39},"Minghui Pharmaceutical (Hangzhou) Ltd","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":55,"locationsCount":4},"100637838","phase-3-treatment-of-chronic-thyroid-eye-disease-with-mhb018a-100637838","NCT07622121","Treatment of Chronic Thyroid Eye Disease With MHB018A","A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.\n4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.\n4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.\n6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops\u002Fointments for TED within 4 weeks before the first dose; subjects who received periorbital\u002Forbital steroid injections within 3 months before the first dose.\n7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).\n8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.\n9. Previous treatment targeting IGF-1R.\n10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed.\n11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.\n12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.\n13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal\u002Fsquamous cell carcinoma of the skin).\n14. Acute cardiovascular disease history or treatment within 6 months before the first dose.\n15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n16. Pregnant or lactating women.\n17. Drug or alcohol abuse during the screening period.\n18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.\n19. Biopsy-proven or clinically suspected inflammatory bowel disease.\n20. Positive results for serum virology tests (defined as pos\n21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.\n22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.\n23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.\n\n    \\-",{"count":48,"type":21},135,[24],"The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.",[27],{"date":31,"type":32},{"date":34,"type":21},{"date":36,"type":21},{"name":38,"class":39},{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100637296","phase-3-open-label-extension-study-of-mhb018a-in-patients-with-thyroid-eye-disease-100637296","NCT07620405","Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease","A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).\n4. Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \\\u003C2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and\u002For who meet the retreatment criteria for relapse during the safety follow-up period.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n4. Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.\n5. Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.\n6. Acute cardiovascular disease history or treatment within 6 months before the first dose from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.\n7. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n8. Pregnant or lactating women.\n9. Tinnitus or other hearing impairment.\n10. Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.\n\n    \\-",{"count":64,"type":21},219,[24],"This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.",[68],"Thyroid Eye Disease (TED)",{"date":31,"type":32},{"date":71,"type":21},"2027-07",{"date":73,"type":21},"2031-01",{"name":38,"class":39},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100618043","phase-1-a-study-of-mhb009c-in-patients-with-advanced-solid-tumors-100618043","NCT07326488","A Study of MHB009C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. At least one measurable lesion per RECIST v1.1 criteria or one bone.\n7. Adequate bone marrow reserve and organ function. -\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.\n4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n5. Severe bone damage caused by bone metastasis of prostate cancer.\n6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.\n7. Severe lung disease affecting pulmonary function.\n8. Vaccinated within 4 weeks before dosing.\n9. Active systemic infection requiring treatment within 7 days before dosing.\n10. Serious cardiovascular or cerebrovascular diseases.\n11. Uncontrolled third-space effusions not suitable for enrollment.\n12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.\n13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n14. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n15. Known alcohol or drug dependence.\n16. Pregnant or breastfeeding women, or individuals planning to conceive. -",{"count":83,"type":21},200,[85,86],"PHASE1","PHASE2","This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C monotherapy.",[89],"Advanced Malignant Solid Tumor","RECRUITING","2026-04-08",{"date":93,"type":32},"2026-04-13",{"date":95,"type":32},"2026-03-17",{"date":97,"type":21},"2029-03",{"name":38,"class":39},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":99},"100607712","phase-1-a-study-of-mhb048c-in-patients-with-advanced-solid-tumors-100607712","NCT07192120","A Study of MHB048C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors",{"count":83,"type":21},[85,86],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.",[110,89],"mCRPC (Metastatic Castration-resistant Prostate Cancer)",{"date":112,"type":32},"2026-04-09",{"date":114,"type":32},"2026-01-16",{"date":116,"type":21},"2029-10",{"name":38,"class":39},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":99},"100607711","phase-1-a-study-of-mhb042c-in-patients-with-advanced-solid-tumors-100607711","NCT07192107","A Study of MHB042C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors",{"count":83,"type":21},[85,86],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.",[89],{"date":112,"type":32},{"date":130,"type":32},"2025-11-27",{"date":116,"type":21},{"name":38,"class":39},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":66,"conditions":141,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":99},"100613122","phase-3-open-label-extension-study-of-mhb018a-in-subjects-with-thyroid-eye-disease-100613122","NCT07262476","Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease",{"count":139,"type":21},258,[24],[68],"2026-03-27",{"date":144,"type":32},"2026-03-30",{"date":146,"type":32},"2026-01-09",{"date":148,"type":21},"2030-01-31",{"name":38,"class":39},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":99},"100612715","phase-3-mhb018a-treatment-in-patients-with-chronic-thyroid-eye-disease-100612715","NCT07257185","MHB018A Treatment in Patients With Chronic Thyroid Eye Disease","A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease.","Interventional",{"count":158,"type":21},150,[24],"The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED.",[68],{"date":144,"type":32},{"date":95,"type":32},{"date":165,"type":21},"2028-08-31",{"name":38,"class":39},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":99},"100592168","phase-3-mhb018a-treatment-in-patients-with-active-thyroid-eye-disease-100592168","NCT06989918","MHB018A Treatment in Patients With Active Thyroid Eye Disease","A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease.",{"count":174,"type":21},108,[24],"The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.",[178],"Thyroid Associated Ophthalmopathies",{"date":180,"type":32},"2026-04-02",{"date":182,"type":32},"2025-07-22",{"date":184,"type":21},"2027-07-31",{"name":38,"class":39},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":99},"100602966","phase-2-a-study-of-mhb036c-combined-with-mhb039a-in-patients-with-advanced-breast-cancer-or-other-advanced-malignant-solid-tumors-100602966","NCT07130383","A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 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. Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors.\n6. At least one measurable lesion per RECIST v1.1 criteria.\n7. Adequate bone marrow reserve and organ function.\n8. 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. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n4. Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.\n5. Vaccinated with attenuated live vaccines within 4 weeks before dosing.\n6. Treated with with systemic corticosteroids within 14 days before dosing.\n7. Central nervous system metastasis.\n8. Uncontrolled third-space effusion.\n9. Serious cardiovascular or cerebrovascular diseases.\n10. Severe lung disease affecting pulmonary function.\n11. Active infection requiring systemic therapy.\n12. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n13. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n14. Known alcohol or drug dependence.\n15. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":194,"type":21},210,[86],"This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.",[198,89],"Advanced Breast Cancer","2025-11-16",{"date":201,"type":32},"2025-11-18",{"date":203,"type":32},"2025-09-30",{"date":205,"type":21},"2031-08",{"name":38,"class":39},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":223,"locationsCount":99},"100602680","phase-1-a-study-of-mhb088c-combined-with-mhb039a-in-patients-with-advanced-malignant-solid-tumors-100602680","NCT07126665","A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors","An Open-label Phase I\u002FII Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 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\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before dosing.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n4. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n5. 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.\n6. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.\n7. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.\n8. Vaccinated within 4 weeks before dosing.\n9. Treated with systemic corticosteroids within 14 days before dosing.\n10. Severe lung disease affecting pulmonary function.\n11. Active systemic infection requiring treatment within 7 days before dosing.\n12. Uncontrolled third-space effusion.\n13. Serious cardiovascular or cerebrovascular diseases.\n14. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n15. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n16. Known alcohol or drug dependence.\n17. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":215,"type":21},116,[85,86],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.",[89],{"date":201,"type":32},{"date":221,"type":32},"2025-09-18",{"date":205,"type":21},{"name":38,"class":39},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":99},"100610593","phase-1-a-study-of-mhb036c-combined-with-anti-tumor-therapies-in-patients-with-advanced-lung-cancer-100610593","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. -",{"count":232,"type":21},300,[85,86],"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.",[236],"Advanced Lung Cancer","2025-11-13",{"date":239,"type":32},"2025-11-17",{"date":241,"type":32},"2025-05-09",{"date":243,"type":21},"2030-05",{"name":38,"class":39},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":99},"100591817","phase-1-a-study-of-mhb046c-injection-in-patients-with-advanced-solid-tumors-100591817","NCT06985355","A Study of MHB046C Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Able to understand and comply with the study protocol and follow-up procedures.\n6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.\n4. Severe lung disease affecting pulmonary function.\n5. Active systemic infection requiring treatment within 7 days before dosing.\n6. Serious cardiovascular or cerebrovascular diseases\n7. Uncontrolled third-space effusions not suitable for enrollment:\n8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.\n9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.\n10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n11. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n12. Known alcohol or drug dependence.\n13. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":83,"type":21},[85,86],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.",[256],"Advanced Solid Cancer","2025-09-16",{"date":221,"type":32},{"date":260,"type":32},"2025-07-17",{"date":262,"type":21},"2031-05",{"name":38,"class":39},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":99},"100596438","phase-1-a-study-of-mhb118c-injection-in-patients-with-advanced-solid-tumors-100596438","NCT07045454","A Study of MHB118C Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Able to understand and comply with the study protocol and follow-up procedures.\n6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n4. Severe lung disease affecting pulmonary function.\n5. Active systemic infection requiring treatment within 7 days before dosing.\n6. Serious cardiovascular or cerebrovascular diseases\n7. Uncontrolled third-space effusions not suitable for enrollment.\n8. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n9. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n10. Known alcohol or drug dependence.\n11. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":83,"type":21},[85],"This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C monotherapy.",[89],"2025-06-22",{"date":277,"type":32},"2025-07-01",{"date":279,"type":32},"2025-03-31",{"date":281,"type":21},"2031-03",{"name":38,"class":39},""]