[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CSPC Megalith Biopharmaceutical Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":522},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,41,62,84,104,126,148,168,189,210,231,252,273,294,315,337,356,377,398,418,439,460,481,501],{"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":40},"100587407","phase-3-phase-iii-trial-of-sys6010-versus-platinum-based-chemotherapy-for-egfr-mutated-nsclcsynstar01-100587407",false,"NCT06927986","Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）","A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Patients with pathologically confirmed locally advanced or metastatic NSCLC, including those with stage IIIB or IIIC based on 8th edition of the AJCC staging system who are not suitable for surgical resection or radical chemoradiotherapy, or those with stage IV NSCLC. Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy，whereas patients progressed on first- or second-generation EGFR-TKIs must have also progressed on third-generation EGFR-TKIs if T790M mutation was detected as postive status.\n3. Presence of at least one EGFR-sensitive mutation;\n4. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria;\n5. ECOG performance status of 0-1;\n6. Life expectancy ≥ 3 months;\n7. Major organ function must meet the following criteria within 7 days prior to randomizationn (No component transfusion, G-CSF, TPO, IL-11, or EPO within 2 weeks prior to randomization):\n\n   Hematology： Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL; Hemoglobin (HGB) ≥100g\u002FL. Renal function Cr：≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL\u002Fmin; Liver function Serum total bilirubin (TBIL) ：≤ 1.5 × ULN, ≤ 3 × ULN for patients with Gilbert syndrome\u002Fmetastases to liver Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)：≤ 2.5 × ULN, ≤ 5 × ULN for patients with metastases to liver Coagulation function Coagulation function Activated partial thromboplastin time (APTT) and international normalised ratio (INR)： ≤1.5×ULN\n8. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n9. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed combined small cell lung cancer,squamous cell carcinoma, neuroendocrine carcinoma,or carcinosarcoma\n2. Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to randomization (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n3. Patients with a history of other malignant tumors within 3 years prior to randomization, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n4. Patients who are known to be allergic to any component of SYS6010 or to humanized monoclonal antibody products; allergic to carboplatin, cisplatin, or pemetrexed, or have contraindications for their use;\n5. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;\n6. Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included;\n7. Patients who have not met the corresponding washout period requirements for the following medications or treatments should be excluded:\n\n   1. Major surgery (excluding needle biopsy)：At least 4 weeks\n   2. Small molecule targeted drugs, traditional Chinese medicines with anti-tumor indications, palliative radiation or local therapy：At least 2 weeks\n   3. intravenous injection of antibiotics, antifungals, or antivirals：At least 2 weeks\n   4. Investigational product and Live attenuated vaccine：At least 4 weeks\n   5. Strong CYP3A4 inducers or inhibitors ,OATP1B1 and OATP1B3 inhibitors：At least 2 weeks\n8. History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to:\n\n   1. Presence of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, third-degree atrioventricular block, Fridericia-corrected QT interval \\> 470 ms (Fridericia formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate);\n   2. History of myocardial infarction, unstable angina pectoris, aortic dissection, angioplasty, or coronary artery bypass;\n   3. NYHA class II or higher cardiac failure, LVEF\\\u003C50% at screening;\n   4. Stroke or other Grade 3 or higher cardiovascular and cerebrovascular events;\n   5. Pulmonary embolism;\n9. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to randomization, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to randomization;\n12. Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;\n13. History of ulcerative colitis or Crohn's disease;\n14. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;\n15. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before randomization, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n16. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n17. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus).","ALL","18 Years","75 Years",{"count":20,"type":21},380,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)",[27],"EGFR-mutated Locally Advanced or Metastatic NSCLC","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2025-03-30",{"date":36,"type":21},"2026-08-30",{"name":38,"class":39},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100644485","phase-3-a-study-of-sys6010-plus-anti-pd-l-1-monoclonal-antibody-as-adjuvant-therapy-in-non-small-cell-lung-cancer-nsclc-100644485","NCT07672223","A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)","A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.","Inclusion Criteria:\n\n1. Able to understand and willingness to voluntarily provide written informed consent.\n2. Age 18 to 75 years, males or females.\n3. Histologically confirmed squamous or non-squamous NSCLC.\n4. Ability to provide qualified tumor samples.\n5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.\n6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).\n7. The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).\n\nExclusion Criteria:\n\n1. Participants with a condition requiring further surgical resection, in the investigator's opinion.\n2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.\n3. Eligible only for incomplete resection.\n4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.\n5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.\n6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":49,"type":21},570,[24],"The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).",[53],"Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-25",{"date":57,"type":32},"2026-06-26",{"date":55,"type":21},{"date":60,"type":21},"2031-11-30",{"name":38,"class":39},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100642456","phase-2-a-clinical-study-of-sys6023-combination-therapy-for-advanced-breast-cancer-100642456","NCT07597629","A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer","A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old;\n* 2\\. Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer:\n* 3\\. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;\n* 4\\. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;\n* 5\\. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);\n* 6\\. ECOG PS score 0-1;\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Adequate organ function with laboratory tests meeting criteria (no blood transfusion or hematopoietic growth factor therapy within 14 days before testing): ANC ≥ 1.5 × 10\\^9\u002FL PLT ≥ 100 × 10\\^9\u002FL Hb ≥ 90 g\u002FL TBIL ≤ 1.5 × ULN ALT, AST ≤ 2.5 × ULN; for participants with liver metastasis, ALT and AST ≤ 5 × ULN Creatinine clearance rate (Ccr) \\> 35 mL\u002Fmin (calculated according to Cockcroft-Gault formula) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 55% (only applicable to Cohort 2)\n* 9\\. Eligible individuals with reproductive potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 7 months after the last dose; Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment;\n* 10\\. Fully understand this clinical trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with HER3-targeted ADC therapy;\n* 2\\. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and\u002For other life-threatening complications;\n* 3\\. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg\u002Fm\\^2doxorubicin equivalent; b. LVEF once dropped to \\\u003C 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;\n* 4\\. History of other malignancies within 3 years before randomization\u002Ffirst dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);\n* 5\\. Untreated (including those detected during screening period) or unstable brain parenchymal metastasis, spinal cord metastasis or compression, carcinomatous meningitis. Subjects with treated stable brain metastases may be considered for enrollment (Note: refers to participants who have received local brain treatment, whose symptoms are stable, imaging tests show stability for at least 28 days before randomization\u002Ffirst dose, no evidence of progressive brain edema, and no need for glucocorticoids or other symptom control measures);\n* 6\\. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk);\n* 7\\. Major surgery within 28 days before randomization\u002Ffirst dose, or planned to undergo systemic or local tumor resection during the study period;\n* 8\\. History of severe bleeding risk (e.g., gastrointestinal varices) or bleeding diathesis, any gastrointestinal bleeding or other bleeding of ≥ CTCAE grade 2 within 28 days before randomization\u002Ffirst dose; Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before randomization\u002Ffirst dose;\n* 9\\. History of severe cardiovascular disease, including but not limited to:\n\n  1. Acute coronary syndrome within 6 months before randomization\u002Ffirst dose;\n  2. Stroke or transient ischemic attack within 6 months before randomization\u002Ffirst dose;\n  3. Pulmonary embolism or deep vein thrombosis within 3 months before randomization\u002Ffirst dose (intermuscular vein thrombosis may be enrolled if assessed as low risk by researchers);\n  4. CHF with NYHA functional classification ≥ II;\n  5. Documented history of cardiomyopathy that has not currently recovered;\n  6. Pericarditis;\n  7. Severe arrhythmia, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.;\n  8. Baseline average QTcF \\> 450 ms (calculated using Fridericia formula), or history or family history of long QT syndrome;\n  9. Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication);\n* 10\\. Presence of non-infectious lung disease\u002Fpneumonia requiring treatment at randomization\u002Ffirst dose, or history of interstitial lung disease\u002Fpneumonia requiring glucocorticoid treatment during prior anti-tumor therapy;\n* 11\\. Active bacterial, fungal or viral infection within 14 days before randomization\u002Ffirst dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy). Individuals receiving prophylactic anti-infective therapy without clinical manifestations of active infection may be considered for enrollment;\n* 12\\. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \\> 2000 IU\u002FmL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \\> ULN for active hepatitis C;\n* 13\\. History of immunodeficiency or positive HIV antibody test during screening;\n* 14\\. Use of strong CYP3A4 inducers or inhibitors, OATP1B1 or OATP1B3 inhibitors before randomization\u002Ffirst dose (within 5 half-lives of inducer or inhibitor) or need to use such drugs during study treatment;\n* 15\\. Known or suspected hypersensitivity to the study drug or its components;\n* 16\\. Lactating women;\n* 17\\. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.",{"count":70,"type":21},36,[72],"PHASE2","This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.",[75],"Advanced Breast Cancer","2026-06-15",{"date":78,"type":32},"2026-06-16",{"date":80,"type":32},"2026-05-25",{"date":82,"type":21},"2029-05-30",{"name":38,"class":39},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":4},"100642904","phase-3-sys6010-combined-with-enlonstobart-versus-immunotherapy-platinum-based-chemotherapy-for-patients-with-pd-l1-positive-locally-advanced-or-metastatic-nsclcsynstar-04-100642904","NCT07633873","SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04）","An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Participants with pathologically confirmed locally advanced or metastatic NSCLC. Including participants with stage IIIB or IIIC according to the 9th edition of AJCC staging who are not suitable for surgical resection or radical chemoradiotherapy, or participants with stage IV NSCLC\n3. Participants who have not previously received systemic anti-tumor treatment. Those who have previously received adjuvant\u002Fneoadjuvant therapy will be allowed for inclusion if disease progression occurs 12 months after the end of treatment.\n4. EGFR mutation negative and ALK fusion negative\n5. Participants with PD-L1 TPS≥1% according to centralized laboratory test\n6. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria\n7. ECOG performance status of 0-1;\n8. Life expectancy ≥ 3 months;\n9. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention\n10. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n11. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;\n2. Participants with ROS1\u002FRET\u002FNTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.\n3. Participants with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n4. Participants with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n5. Participants who are known to be allergic to any component of SYS6010, Enlonstobart, Tislelizumab or to humanized monoclonal antibody products or ; Paclitaxel\u002FCarboplatin\u002F Pemetrexed\u002FCisplatin.\n6. Previously treated with topoisomerase I inhibitor toxin ADC therapy\n7. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v6.0; Participants who experienced ≥ grade 3 irAEs during previous treatment, or who permanently discontinued medication due to irAEs\n8. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded；\n9. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\\\\\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;\n12. Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.\n13. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;\n14. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×10\\^4 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n15. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n16. Other conditions that the investigator deem unsuitable for participation in this clinical study. Such as mental illness, uncontrolled or poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥95 mmHg after standardized antihypertensive treatment), and diabetes, etc.",{"count":92,"type":21},500,[24],"This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.",[96],"Non-Small Cell Lung Cancer","2026-06-09",{"date":99,"type":32},"2026-06-11",{"date":101,"type":21},"2026-06-02",{"date":82,"type":21},{"name":38,"class":39},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100638092","phase-1-sys6006-in-combination-with-enlonstobart-injection-versus-enlonstobart-injection-in-participants-with-advanced-solid-tumors-100638092","NCT07622225","SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the written informed consent form (ICF);\n* 2\\. Male or female subjects aged over 18 years old (inclusive).\n* 3\\. Patients with solid tumor who have unresectable locally advanced or metastatic disease;\n* 4\\. At least one measurable lesion, as defined by RECIST 1.1 criteria;\n* 5\\. ECOG performance status of 0-2;\n* 6\\. Expected survival ≥ 3 months;\n* 7\\. Adequate function of major organs and bone marrow;\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;\n* 2\\. Patients with a history of autoimmune diseases;\n* 3\\. Presence of active infection (e.g., subjects are receiving anti-infection therapy);\n* 4\\. Severe or uncontrolled cardiovascular disorder requiring treatment;\n* 5\\. Women who are pregnant or breastfeeding.",{"count":112,"type":21},264,[114,72],"PHASE1","This study is a Phase Ib\u002FII clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.",[117],"Advanced Solid Tumors","2026-05-30",{"date":120,"type":32},"2026-06-03",{"date":122,"type":21},"2026-05-29",{"date":124,"type":21},"2030-01-31",{"name":38,"class":39},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100621881","phase-3-a-phase--clinical-study-of-sys6010-in-combination-with-osimertinib-in-patients-with-locally-advanced-or-metastatic-nsclc-100621881","NCT07376382","A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC","A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","SYNSTAR-02","Inclusion Criteria:\n\n1. Age 18 \\~ 75 (inclusive) years old, regardless of gender;\n2. Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC. For the dose escalation phase, patients must have EGFR-mutant locally advanced or metastatic NSCLC that has failed previous standard therapy, and for the dose selection phase and phase III study, patients must have EGFR-mutant locally advanced or metastatic NSCLC, which has not received EGFR-TKIs or other systemic therapy before. Patients who have received adjuvant\u002Fneoadjuvant chemotherapy may be included if disease progression occurred at least 6 months after completing treatment;\n3. Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations). EGFR mutation: Stage Ib: can be enrolled based on previous test results. Phase III: Take the test results of the central laboratory as the admission group;\n4. At least one measurable lesion confirmed by CT or MRI, as defined by RECIST v1.1 criteria;\n5. ECOG performance status score 0-1;\n6. Expected survival ≥ 3 months;\n7. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n8. Women of childbearing age had a negative blood pregnancy test within 7 days prior to the first use of study drug. Participants must agree to take effective contraceptive measures from signing the informed consent form to 7 months after the last dose, during which women are non-breastfeeding and men avoid sperm donation;\n9. Volunteer to participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, or active CNS metastases;\n2. History of other malignant tumors within 3 years prior to the first use of study drug, except for the following conditions: cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, or cervical carcinoma in situ, etc.;\n3. Known allergies to SYS6010 or any ingredient of Osimertinib, or to humanized monoclonal antibodies;\n4. Adverse events caused by prior anti-tumor therapy that have not resolved to ≤ Grade 1 (as per NCI-CTCAE v6.0), except for Grade 2 alopecia or peripheral neuropathy deemed by the investigator not to pose a safety risk;\n5. Use of any of the medications or treatments within the specified washout period (prior to first dose of study drug)\n6. History of serious cardiovascular or cerebrovascular conditions within 6 months prior to the first dose, including but not limited to:Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF \\> 470 ms) (Fridericia formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF \\\u003C 50%.Stroke or other grade ≥ 3 cardiovascular\u002Fcerebrovascular events. pulmonary embolism.\n7. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n8. Severe infection within 4 weeks prior to the first dose, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis; Active systemic infections requiring antibiotics within 2 weeks prior to administration;\n9. Currently suffering from a skin condition requiring oral or vein administration;\n10. Participants with active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis or Crohn's disease) are excluded from the study. However, participants with the following conditions may be considered eligible for further screening: those with well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases unlikely to relapse even when exposed to external triggers;\n11. Pleural or peritoneal effusion or pericardial effusion requiring clinical intervention;\n12. Conditions that seriously affect gastrointestinal absorption as judged by the investigator (such as Persistent nausea, vomiting, chronic gastrointestinal diseases, gastrointestinal surgery, etc.);\n13. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copy number ≥ 1 × 104 copy number\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA higher than the lower detection limit of the analytical method), Note: For HBsAg positive, it is recommended to start antiviral therapy before the first use of study drug, and Nucleosides analogs such as Entecavir and Tenofovir disoproxil are recommended);\n14. History of immunodeficiency (including positive HIV test, other acquired, congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplantation;\n15. Other conditions (e.g. mental illness, macular cystic edema, severe corneal diseases, uncontrolled or poorly controlled hypertension and diabetes, active bleeding, etc.) that the investigator considers inappropriate to participate in this clinical trial.",{"count":135,"type":21},680,[24],"This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups:\n\nTest group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）",[139],"NSCLC","2026-05-11",{"date":142,"type":32},"2026-05-13",{"date":144,"type":21},"2026-06-01",{"date":146,"type":21},"2029-06-06",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100640375","phase-1-a-study-of-sys6051-in-subjects-with-advanced-solid-tumors-100640375","NCT07591285","A Study of SYS6051 in Subjects With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Fully understand the clinical study and voluntarily sign the written ICF;\n2. Age ≥ 18 years;\n3. Have at least one measurable lesion according to RECIST 1.1;\n4. ECOG performance status score of 0 to 1;\n5. Have adequate organ function;\n6. Expected survival of at least 3 months;\n7. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;\n8. Histologically or cytologically confirmed diagnosis of advanced solid tumors. -\n\nExclusion Criteria:\n\n1\\. Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease\u002Fpneumonitis requiring steroid hormone therapy or current interstitial lung disease\u002Fpneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.\n\n\\-",{"count":156,"type":21},114,[114],"This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.",[117],"2026-05-09",{"date":162,"type":32},"2026-05-15",{"date":164,"type":21},"2026-05-12",{"date":166,"type":21},"2028-06-30",{"name":38,"class":39},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100633446","phase-3-sys6002-vs-chemotherapy-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-100633446","NCT07526792","SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial of SYS6002 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure of Platinum-based Chemotherapy andPD-(L)1 Inhibitors","Inclusion Criteria:\n\n* 1.Participantss aged 18-75 years (inclusive);\n* 2\\. Pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma\n* 3 Participants havefailed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant\u002Fneoadjuvant setting, disease recurrence or progression must have occurred within 12 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;\n* 4 Participants must have measurable disease according to RECIST (version 1.1);\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 6 Life expectancy of ≥ 3 months;\n* 7 Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to treatment;\n* 8 Sexually active fertile participants must agree to use methods of contraception during the study and at least 6 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 9 Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system metastases or leptomeningeal metastasis;\n* 2\\. Prior Nectin-4-targeted therapy;\n* 3\\. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v5.0；\n* 4\\. Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's participation in the study:\n\n  1. History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate);\n     2. With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery;\n     3. New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period;\n     4. Ischemic or Hemorrhagic Stroke;\n     5. Pulmonary Embolism Accident;\n  2. Other clinically significant diseases:\n\n     1. HbA1c \\> 8%;\n     2. Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness;\n     3. Grade ≥2 neuropathy prior to randomization;\n     4. Severe infection within 4 weeks prior to randomization; Active infection of Grade ≥2 (CTCAE v5.0) requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to randomization;\n     5. Active HBV or HCV infection;\n     6. History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation;\n     7. History of another malignancy within 3 years prior to randomization;\n     8. History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor;\n     9. Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n* 5\\. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy, or targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization; or major surgery within 4 weeks prior to randomization;\n* 6\\. Allergy to any component of SYS6002 or to humanized monoclonal antibodies;\n* 7\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":176,"type":21},406,[24],"This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma.\n\nThis study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).",[180],"Urothelial Carcinoma","2026-04-07",{"date":183,"type":32},"2026-04-13",{"date":185,"type":21},"2026-06-20",{"date":187,"type":21},"2029-12-01",{"name":38,"class":39},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100626971","phase-3-sys6010-versus-docetaxel-for-previously-treated-egfr-wild-type-nsclc-phase--100626971","NCT07442565","SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ","A Randomized, Open-label, Multicenter Phase III Study Comparing SYS6010 With Docetaxel in Patients With Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Who Have Failed Standard Therapy","SYNSTAR03","Inclusion Criteria:\n\n1\\. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the written ICF (Informed Consent Form); 2. Age ≥18 years, with no restriction on sex; 3. Patients with pathologically confirmed locally advanced or metastatic EGFR wild-type non-squamous non-small cell lung cancer (nsq-NSCLC). Stage IIIB or IIIC patients unsuitable for surgical resection or radical chemoradiotherapy, or Stage IV NSCLC patients. EGFR mutations (currently approved by regulatory authorities for targeted therapy) must be confirmed negative. If test results are unavailable, participants need to provide tumor tissue to undergo genetic testing.\n\n4\\. Meet either of the following requirements regarding prior treatment for locally advanced or metastatic EGFR wild-type nsq-NSCLC:\n\n1. Driver gene-negative population must have failed only immune therapy and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).\n2. Other driver gene-positive populations must have received and failed only targeted therapy for the driver gene and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).\n\n   5\\. Have at least one measurable lesion confirmed by CT or MRI according to RECIST v1.1 criteria; 6. ECOG performance status score 0-1; 7. Expected survival ≥3 months as judged by the investigator. 8. Within 7 days before the first administration, the body organs and bone marrow function meet the requirements, defined as follows (Note: For hematological tests, participants must not have received blood component transfusion, G-CSF, TPO, TPO-RA, IL-11, or EPO within 2 weeks prior to randomization):\n   1. ANC ≥1.5×10⁹\u002FL\n   2. Platelets (PLT) ≥100×10⁹\u002FL\n   3. Hemoglobin (HGB) ≥100 g\u002FL\n   4. Serum creatinine (Cr) ≤1.5×ULN AND creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n   5. Total bilirubin (TBIL): ≤1.5×ULN for patients without liver metastases; ≤3×ULN for patients with Gilbert's syndrome or liver metastases\n   6. ALT\u002FAST: ≤2.5×ULN for patients without liver metastases; ≤5×ULN for patients with liver metastases\n   7. APTT and INR ≤1.5×ULN 9. Female participants of childbearing potential must have a negative pregnancy test within 7 days before randomization. All participants must agree to use effective contraception from the time of signing the ICF until 7 months after the last dose. During this period, female participants must not be breastfeeding, and male participants must refrain from sperm donation.\n\n   Exclusion Criteria:\n   1. Histologically or cytologically confirmed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma\n   2. Patients with: Leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastases.\n\n      Exception: Supratentorial and\u002For cerebellar metastases (excluding midbrain, pons, or medulla) are allowed if: Received local therapy (e.g., radiation\u002Fsurgery) Stable for ≥2 weeks before randomization (no new lesions\u002Fenlargement on imaging, stable\u002Fimproved neurological symptoms). No corticosteroids or ≤10 mg prednisone (or equivalent) daily.\n   3. Other malignancies within 3 years before randomization, except: Cured basal\u002Fsquamous cell skin cancer, superficial bladder cancer, prostate\u002Fcervical carcinoma in situ.\n   4. Known allergies: To any component of SYS6010 or humanized monoclonal antibodies. Contraindications\u002Fhypersensitivity to docetaxel.\n   5. Residual toxicities from prior antitumor therapy \\> Grade 1 (per NCI-CTCAE v6.0), except: Grade 2 alopecia or other toxicities deemed non-risky by investigators.\n   6. Prior treatment with topoisomerase I inhibitors (including ADCs).\n   7. Inadequate washout periods:\n\n   \u003C!-- -->\n\n   1. Major surgery (excluding biopsies) within 4 weeks before first dose.\n   2. Last antitumor therapy before first dose:\n\n      Chemotherapy\u002Fradical radiotherapy\u002Ftargeted\u002Fimmunotherapy: ≥4 weeks. Small-molecule targeted drugs\u002FTCM with antitumor claims\u002Fpalliative radiotherapy\u002Flocal therapy: ≥2 weeks.\n   3. Within 2 weeks before first dose: IV antibiotics\u002Fantifungals\u002Fantivirals for the purpose of anti-infective therapy; strong CYP3A4 inducers\u002Finhibitors; OATP1B1\u002F1B3 inhibitors.\n   4. Investigational drugs\u002Flive vaccines within 4 weeks before first dose. 8. Severe cardiovascular diseases within 6 months before randomization, including: Clinically significant arrhythmias (e.g., ventricular arrhythmia, AV block ≥ Grade III); QTcF \\>470 ms (Fridericia's formula) Myocardial infarction, unstable angina, aortic dissection, angioplasty, CABG. Heart failure ≥ NYHA Class II or LVEF \\\u003C50%. Stroke or Grade ≥3 cardiovascular events. Pulmonary embolism. 9. History of ILD\u002Fnon-infectious pneumonitis requiring steroids; current ILD; or suspected ILD on imaging\u002Fpulmonary function tests (severe ventilation\u002Fdiffusion impairment).\n\n   10\\. Severe infections within 4 weeks before randomization (e.g., bacteremia, severe pneumonia, active TB); active infections requiring IV antibiotics within 2 weeks.\n\n   11\\. History of ulcerative colitis or Crohn's disease. 12. Pleural\u002Fpericardial effusion requiring intervention within 2 weeks. 13. Active HBV\u002FHCV infection: HBV: HBsAg+ and\u002For HBcAb+ with HBV DNA ≥10⁴ copies\u002FmL (or ≥2000 IU\u002FmL).\n\n   HCV: HCV Ab+ with HCV RNA above detection limit. Note: Antiviral therapy (e.g., entecavir\u002Ftenofovir) is recommended for HBsAg+ patients before randomization.\n\n   14\\. Immunodeficiency (HIV+, congenital\u002Facquired immune disorders) or allogeneic transplant history.\n\n   15\\. Other conditions deemed ineligible by investigators (e.g., uncontrolled psychiatric disorders, hypertension\u002Fdiabetes).",{"count":198,"type":21},506,[24],"This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.",[96],"2026-03-02",{"date":204,"type":32},"2026-03-04",{"date":206,"type":21},"2026-03-10",{"date":208,"type":21},"2031-05-30",{"name":38,"class":39},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100625061","phase-3-sys6010-versus-chemotherapy-in-locally-advanced-or-metastaticrecurrent-esophageal-squamous-cell-carcinoma-100625061","NCT07417735","SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic\u002FRecurrent Esophageal Squamous Cell Carcinoma","A Randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SYS6010 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic\u002FRecurrent Esophageal Squamous Cell Carcinoma Who Have Failed at Least One Line of Systemic Therapy.","Inclusion Criteria:\n\n1. Voluntarily sign the Informed Consent Form (ICF);\n2. Aged ≥18 years at the time of ICF signing, regardless of gender;\n3. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) with unresectable locally advanced disease, local recurrence, or distant metastasis;\n4. Subjects with disease progression or intolerance after at least one line of systemic therapy.\n5. At least one evaluable lesion meeting the criteria of RECIST 1.1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. Expected survival≥3 months;\n8. Major organ functions meeting the prespecified criteria within 3 days prior to randomization\n9. Male participants and female participants of childbearing potential must agree to adopt effective contraceptive measures from the time of signing the ICF until 7 months after the last dose; during this period, female participants must not be breastfeeding and male participants must refrain from sperm donation. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization.\n\nExclusion Criteria:\n\n1. A past pathological diagnosis of esophageal cancer with adenocarcinoma, adenosquamous carcinoma, or other pathological types.\n2. Active central nervous system (CNS) metastasis and\u002For meningeal metastasis. Subjects with supratentorial and\u002For cerebellar (i.e., no midbrain, pons, or medulla oblongata) metastasis who achieve stable disease for at least 4 weeks prior to randomization after local therapy (imaging shows no new brain metastases or no enlargement of existing brain metastatic lesions, and all neurological symptoms are stable or return to normal), and who do not require glucocorticoid therapy or are receiving a daily prednisone dose of ≤10 mg or an equivalent dose of other glucocorticoids, are eligible for the study.\n3. Receipt of any anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks prior to randomization, with the exception of the following:\n\n   1. Receipt of oral chemotherapeutic agents or small-molecule targeted therapy agents within 2 weeks prior to randomization or within 5 half-lives of the drug (whichever is shorter);\n   2. Receipt of traditional Chinese medicine (TCM) or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to randomization;\n   3. Receipt of local palliative radiotherapy for the purpose of relieving bone metastasis pain within 2 weeks prior to randomization;\n   4. Receipt of major surgical treatment (excluding needle biopsy), participation in other clinical trials with study drug administration, or vaccination with live-attenuated vaccines within 4 weeks prior to randomization, or anticipated need for live-attenuated vaccine vaccination during the study period.\n4. Known hypersensitivity to any component of SYS6010, or to humanized monoclonal antibody products; hypersensitivity or contraindication to irinotecan, paclitaxel, or docetaxel.\n5. Prior receipt of treatment with irinotecan-containing drugs or topoisomerase Ⅰ inhibitor-toxin antibody-drug conjugate (ADC) products.\n6. Body mass index (BMI) \\\u003C 16.0 kg\u002Fm\\^2 or body weight \\\u003C 40 kg.\n7. A history of any other active malignant tumor within 5 years (except for radically resected and non-recurrent basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, or other carcinomas in situ).\n8. Presence of bleeding diathesis; active bleeding, hemoptysis, or a history of major bleeding within the past 6 months; imaging (CT or MRI) showing tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major blood vessels during the subsequent study period leading to fatal massive bleeding.\n9. Presence of any severe and\u002For uncontrolled disease prior to randomization, including but not limited to:\n\n   1. Myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ Ⅱ), unstable angina pectoris, coronary angioplasty, or bypass surgery within 6 months prior to randomization;\n   2. Left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography during screening;\n   3. Arterial\u002Fdeep venous thrombosis\u002Fcancer-associated thrombosis events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, pulmonary embolism, etc.) within 6 months prior to randomization;\n   4. Uncontrolled serous cavity effusions requiring repeated drainage (e.g., pleural effusion, ascites, pericardial effusion, etc.);\n   5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg with medical management) or a history of hypertensive crisis\u002Fhypertensive encephalopathy;\n   6. Corrected QT interval using Fridericia's formula (QTcF) ≥ 450 ms in males and QTcF ≥ 470 ms in females; or a diagnosis of congenital long QT syndrome, and\u002For known concomitant use of drugs that prolong the QT interval;\n   7. Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.);\n   8. Clinically significant severe electrolyte abnormalities requiring medical treatment as judged by the investigator;\n   9. Poorly controlled diabetes mellitus (fasting blood glucose \\> 10.0 mmol\u002FL).\n10. Active viral hepatitis (positive HBsAg with HBV-DNA ≥ 10\\^4 cps\u002FmL or ≥ 2000 IU\u002FmL; positive HCV antibody with positive HCV viral titer); human immunodeficiency virus antibody (HIV-Ab) positive subjects; active syphilis infection (positive Treponema pallidum antibody with positive Rapid Plasma Reagin \\[RPR\\] or Toluidine Red Unheated Serum Test \\[TRUST\\]).\n11. A past history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or inability to rule out ILD\u002Fnon-infectious pneumonia by imaging examination during screening.\n12. A history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization; or obvious ulceration of the esophageal lesion, tumor invasion of adjacent tissues, or imaging evidence of a risk of tracheoesophageal fistula, and the investigator judges the subject to be unsuitable for anti-angiogenic drug therapy.\n13. A past or current history of mental disorders or epilepsy requiring treatment.\n14. Infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (except for uncomplicated urinary tract infection or upper respiratory tract infection).\n15. Presence of clinically significant gastrointestinal diseases during screening, including bleeding, inflammation, obstruction, intractable vomiting (defined as ≥ 3 episodes of vomiting within 24 hours), and diarrhea of grade \\> 1.\n16. Ingestion of strong CYP3A4 inducers or inhibitors, or OATP1B1\u002FOATP1B3 inhibitors within 2 weeks prior to randomization, or anticipated need for the above drugs during the trial period.\n17. Failure of adverse reactions from prior chemotherapy, surgery, radiotherapy, or other anti-tumor therapies to resolve to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 or baseline levels (except for toxicities with no safety risk as judged by the investigator, such as alopecia).\n18. Presence of skin diseases requiring oral or intravenous drug therapy during screening, and the investigator judges the subject to be unsuitable for study drug administration.\n19. Other conditions that the investigator deems unsuitable for participation in this clinical trial.",{"count":218,"type":21},436,[24],"This study is a randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Study of SYS6010 vs Investigator's Choice Single-Agent Chemotherapy in Locally Advanced\u002FMetastatic\u002FRecurrent ESCC Patients with Failure of At Least One Line of Systemic Therapy",[222],"Locally Advanced\u002FMetastatic\u002FRecurrent ESCC","2026-02-11",{"date":225,"type":32},"2026-02-18",{"date":227,"type":21},"2026-03-18",{"date":229,"type":21},"2029-12-31",{"name":38,"class":39},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":238,"minAge":17,"maxAge":18,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":40},"100624917","phase-1-phase-1ii-clinical-study-of-sys6043-in-the-treatment-of-advancedmetastatic-solid-tumors-100624917","NCT07415863","Phase 1\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Dose-Escalation, PK Expansion and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years inclusive (based on the date of signing the informed consent form). For Cohort 2 and Cohort 10, subjects over 75 years of age are eligible for enrollment.\n2. Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumors with disease recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or no available standard therapy.\n3. At least one extracranial measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For participants with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases only, eligibility for enrollment will be determined following a discussion and assessment with the sponsor's medical monitor on a case-by-case basis.\n4. Expected survival of the participant is ≥ 3 months.\n5. ECOG performance status of 0 or 1 with no deterioration in status identified within 28 days prior to enrollment. For Cohort 2 and Cohort 10, subjects with an ECOG performance status of 2 are eligible for enrollment.\n6. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or radionuclide ventriculography (MUGA) within 28 days prior to enrollment.\n7. Adequate function of major organs meeting the following requirements within 7 days prior to enrollment:\n\n   1. Hematology (no receipt of whole blood, red blood cell or platelet transfusion, and no administration of hematopoietic stimulating factors \\[G-CSF or GM-CSF\\], erythropoietin \\[EPO\\] or thrombopoietin \\[TPO\\] for cytorection within 7 days prior to sample collection):Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL;Platelet count (PLT) ≥ 100×10⁹\u002FL;Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Blood biochemistry:Serum creatinine ≤ 1.5×upper limit of normal (ULN);Serum total bilirubin (TBIL) ≤ 1.5×ULN (may be relaxed to 3×ULN for participants with Gilbert's syndrome);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for participants with hepatocellular carcinoma or liver metastases);Serum albumin ≥ 30 g\u002FL.\n   3. Coagulation function:Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (for participants not receiving anticoagulant therapy); for participants receiving anticoagulant therapy, indices shall be within the therapeutic target range with a stable dosage.\n8. Toxic reactions caused by any prior therapy have recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or baseline levels (except for alopecia, fatigue, peripheral neuropathy and other toxicities that the investigator deems to pose no safety risk to the participant).\n9. Sufficient washout period for prior anti-tumor therapies before the first study drug administration.\n10. Be willing to provide previously resected tumor samples or undergo a fresh tumor biopsy for the detection of B7-H3 expression levels and other biomarkers (if there are no contraindications).\n11. For female participants of childbearing potential, the serum pregnancy test result within 7 days prior to randomization must be negative. Male and female participants with reproductive potential must agree to adopt adequate contraceptive measures during the study period and for at least 7 months after the last administration of the study drug; during this period, female participants must not be breastfeeding, male participants must not freeze or donate sperm, and female participants must not donate or retrieve oocytes for personal use.\n12. Have a full understanding of this clinical trial and voluntarily sign a written informed consent form\n13. Advanced or metastatic solid tumors with failure of standard systemic therapy\n\nExclusion Criteria:\n\n1. Prior receipt of B7-H3-targeted therapy.\n2. Prior receipt of irinotecan, topotecan, any other topoisomerase I inhibitors (including investigational TOP1 inhibitors), or topoisomerase inhibitor antibody-drug conjugates (e.g., trastuzumab deruxtecan). This criterion applies only to the Phase I PK expansion and Phase II cohort expansion stages.\n3. A history of symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV) or severe cardiac arrhythmias requiring treatment.\n4. A history of myocardial infarction or unstable angina within 6 months prior to enrollment.\n5. A prolonged corrected mean QT interval (QTcF) using the Fredericia formula of \\>470 milliseconds (ms) on three 12-lead electrocardiogram (ECG) assessments, for both male and female participants.\n6. Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.\n7. A history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or suspected such disease on imaging during screening.\n8. A history of underlying pulmonary disease, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other clinically significant pulmonary impairment within 3 months prior to the start of study treatment, or the need for supplemental oxygen.\n9. Any autoimmune, connective tissue, or inflammatory disease involving the lungs that is documented or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n10. Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.\n11. Known human immunodeficiency virus (HIV) infection, or currently active syphilis infection (i.e., positive Treponema pallidum antibody \\[RPR or TRUST\\] or syphilis requiring systemic therapy).\n12. Participants with active viral hepatitis (positive hepatitis B surface antigen \\[HBsAg\\] and\u002For positive hepatitis B core antibody \\[anti-HBc\\] with HBV DNA ≥1000 copies\u002FmL or 2000 IU\u002FmL; positive hepatitis C virus \\[HCV\\] with HCV RNA above the lower limit of quantification \\[LLOQ\\] of the assay).\n13. Lactating women (women willing to temporarily discontinue breastfeeding are also excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.\n14. Presence of spinal cord compression, or clinically active brain or meningeal metastases. Participants with central nervous system (CNS) metastases are eligible if: they have received prior CNS-directed therapy and have had radiological and neurological stability for at least 4 weeks before the first dose (i.e., no new or enlarging metastatic lesions on imaging, no requirement for corticosteroid therapy or maintenance of a stable or tapering dose of corticosteroids \\[equivalent to ≤10 mg\u002Fday prednisone\\], and no symptoms); or they have untreated asymptomatic CNS metastases that the investigator assesses as not requiring immediate treatment.\n15. A history of multiple primary malignant neoplasms within 3 years prior to enrollment, except for: adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer); in situ disease treated with curative intent (e.g., cervical or breast carcinoma in situ); and other solid tumors treated with curative intent (e.g., superficial bladder cancer).\n16. A history of substance abuse, or any other medical condition that the investigator deems may increase the safety risk to the participant or interfere with the participant's participation in or evaluation of the clinical study.\n17. Receipt of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of the study drug, or the need for continued use of such medications during the study period.\n18. Known hypersensitivity to the active ingredient or excipients of the study drug.\n19. Presence of pleural, pericardial, or peritoneal effusion with clinical symptoms or requiring repeated drainage.\n20. Any other reason that the investigator deems the participant unsuitable for enrollment in the study","FEMALE",{"count":240,"type":21},820,[114,72],"Phase I\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors This study is a first-in-human phase I\u002FII, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced\u002Fmetastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.",[244],"Advanced\u002FMetastatic Solid Tumors","2026-02-10",{"date":247,"type":32},"2026-02-17",{"date":249,"type":32},"2024-12-30",{"date":166,"type":21},{"name":38,"class":39},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100624200","phase-3-a-phase-iii-study-of-sys6010-versus-chemotherapy-in-her2-negative-egfr-positive-recurrent-or-metastatic-breast-cancer-100624200","NCT07406542","A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer","A Randomized, Open-Label, Parallel-Control, Multicenter Phase III Clinical Study of SYS6010 Versus Investigator's Choice Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Age 18 to 75 years inclusive, no gender restrictions.\n2. Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.\n3. Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.\n4. At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Expected survival ≥3 months.\n7. Adequate major organ function status within 7 days prior to first study drug administration.\n8. Subjects must agree to use effective contraception from informed consent signing until the protocol-specified time after last dose; females must not be lactating and males must refrain from sperm donation during this period. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration. Female subjects must not be lactating.\n9. Voluntarily participate in this clinical study, understand the research procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids\u002Fanticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids\u002Fanticonvulsants for \\>2 weeks.\n2. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).\n3. History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ\n4. Prior treatment with topoisomerase I inhibitors (including ADCs)\n5. Prior treatment with EGFR-targeted ADCs or monoclonal antibodies\n6. Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products\n7. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (excluding Grade 2 alopecia, asymptomatic laboratory abnormalities, etc., deemed safe by the investigator).\n8. Patients with inadequate washout periods for prior medications or treatments, as specified in the protocol, prior to the first administration of the study drug. 9. History of severe cardiovascular or cerebrovascular disease.\n\n10\\. Clinically significant pulmonary impairment due to pulmonary complications. 11. History of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or inability to exclude ILD\u002Fnon-infectious pneumonia based on imaging at screening.\n\n12\\. Subjects with active inflammatory bowel disease, gastrointestinal obstruction, active peptic ulcer, recent (within 4 weeks) gastrointestinal bleeding, gastrointestinal perforation, or severe gastrointestinal conditions such as abdominal abscess (excluding those with a history of resolved conditions).\n\n13\\. Severe infection within 4 weeks prior to first use of the investigational drug, including but not limited to: bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, or requiring oral or intravenous antibiotic, antifungal, or antiviral therapy due to infection within 2 weeks prior to first dosing (except for prophylactic use).\n\n14\\. Uncontrolled diabetes (fasting blood glucose ≥10 mmol\u002FL and\u002For HbA1c ≥8%). 15. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.\n\n16\\. Human immunodeficiency virus (HIV) infection diagnosed as acquired immunodeficiency syndrome (AIDS).\n\n17.Other conditions deemed unsuitable for participation in this clinical trial by the investigator (e.g., uncontrolled psychiatric disorders or anticipated poor compliance).",{"count":260,"type":21},400,[24],"This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent\u002Fmetastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).",[264],"Recurrent or Metastatic Breast Cancer","2026-02-05",{"date":267,"type":32},"2026-02-12",{"date":269,"type":21},"2026-04-01",{"date":271,"type":21},"2030-04-01",{"name":38,"class":39},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":40},"100612515","phase-2-sys6010-combined-with-enlonstobart-in-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100612515","NCT07254585","SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma","An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy.\n3. For SYS6010 combined with Enlonstobart group: Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.\n4. For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone systemic antitumor treatment, baseline PD-L1 positivity (CPS≥1) must be confirmed by the central laboratory; for participants who have previously received systemic antitumor treatment, there is no restriction on baseline PD-L1 expression.\n5. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria\n6. ECOG performance status of 0-1;\n7. Life expectancy ≥ 3 months;\n8. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention\n9. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n10. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or cytologically confirmed combined neuroendocrine carcinoma, mesenchymal tumors or carcinosarcoma.\n2. Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n3. Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n4. Patients who are known to be allergic to any component of SYS6010, Enlonstobart or to humanized monoclonal antibody products;\n5. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;\n6. Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included;\n7. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded:\n8. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\n9. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels;\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;\n12. Previous interruption of EGFR-targeted therapy for ≥1 month or permanent discontinuation due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;\n13. Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.\n14. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;\n15. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n16. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n17. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus)",{"count":281,"type":21},70,[72],"This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.",[285],"Head and Neck Squamous Cell Carcinoma","2026-01-23",{"date":288,"type":32},"2026-01-26",{"date":290,"type":32},"2025-12-18",{"date":292,"type":21},"2027-12-31",{"name":38,"class":39},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100621740","phase-2-sys6002-vs-padcev-in-patients-with-advanced-urothelial-carcinoma-100621740","NCT07374549","SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma","A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* 1\\. Patients aged 18-80 years (inclusive);\n* 2\\. Pathologically confirmed patients with advanced urothelial carcinoma who have received a platinum-based chemotherapy with anti-PD-(L)1 agent. For those who received these therapies in the adjuvant or neoadjuvant setting, disease progression must have occurred during treatment or within 12 months of treatment completion;\n* 3 An archival tumor tissue sample or a fresh tissue sample should be provided;\n* 4 Subjects must have measurable disease according to RECIST (version 1.1);\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 6 Life expectancy of ≥ 3 months;\n* 7 Major organ function must meet the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n* 8Sexually active fertile subjects must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 9.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Active central nervous system metastases or leptomeningeal metastasis;\n* 2.Adverse events from prior anti-tumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；\n* 3.Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's participation in the study:\n\n  1. Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period; cerebrovascular accidents; pulmonary embolisms;\n  2. Other clinically significant diseases:\n\nHbA1c \\> 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifungal therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these conditions, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; Pleural effusion, ascites or pericardial effusion with symptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n\n* 4.Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;\n* 5.Allergy to any component of SYS6002, or humanized monoclonal antibodies; investigator-determined ineligibility for enfortumab vedotin therapy.\n* 6\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.","80 Years",{"count":303,"type":21},100,[72],"This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.\n\nThis study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.",[307],"Advanced Urothelial Carcinoma","2026-01-21",{"date":310,"type":32},"2026-01-29",{"date":185,"type":21},{"date":313,"type":21},"2028-12-01",{"name":38,"class":39},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":322,"sex":16,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100620210","phase-2-immunogenicity-and-safety-of-sys6017-in-the-participants-aged-40-years-and-above-100620210","NCT07354659","Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above","A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above","Inclusion Criteria:\n\n* 1\\. Individuals aged 40 years or older;\n* 2\\. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;\n* 3\\. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);\n* 4\\. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.\n\nExclusion Criteria:\n\n* 1\\. History of zoster;\n* 2\\. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);\n* 3\\. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;\n* 4\\. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);\n* 5\\. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis\n* 6\\. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.;\n* 7\\. Current epilepsy or convulsion, severe neurological or psychiatric disorders;\n* 8\\. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or ongoing treatment with anticoagulants, etc.;\n* 9\\. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;\n* 10\\. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;\n* 11\\. History of diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy before enrollment;\n* 12\\. Long-term (defined as more than 14 consecutive days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids at a dose of ≥ 20 mg\u002Fday prednisone or equivalent) within 6 months prior to enrollment; however, inhaled and topical corticosteroids are permitted; or planned administration of the aforementioned agents during the study period;\n* 13\\. Administration of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned administration of the aforementioned products during the study period;\n* 14\\. Blood donation or blood loss ≥ 450 mL within one month before enrollment, or planning to donate blood during the study;\n* 15\\. Vaccination with any other vaccines within 30 days prior to enrollment, or planned vaccination with any other vaccines within 30 days after the last dose of the study vaccine;\n* 16\\. Current participation in or planned participation in other clinical trials during the study period;\n* 17\\. For female participants of childbearing potential: positive pregnancy test result prior to enrollment, current pregnancy or lactation, or planned pregnancy within 8 months after enrollment;\n* 18\\. Unable to comply with the study procedures and requirements, or presence of other conditions that make the participant inappropriate for this clinical trial, as judged by the investigators.",true,"40 Years",{"count":325,"type":21},800,[72],"Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled \"A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above\".",[329],"Herpes Zoster","2026-01-12",{"date":308,"type":32},{"date":333,"type":21},"2026-01-10",{"date":335,"type":21},"2027-05-31",{"name":38,"class":39},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100612663","phase-2-a-study-of-sys6010-combined-with-osimertinib-versus-osimertinib-alone-as-neoadjuvant-therapy-for-patients-with-egfr-mutation-positive-resectable-non-squamous-non-small-cell-lung-cancer-100612663","NCT07256509","A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer","A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form (ICF);\n2. Age 18-75 years, regardless of sex;\n3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;\n4. Must be eligible for complete surgical resection of the primary tumor;\n5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;\n6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;\n7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);\n8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n10. Life expectancy ≥6 months;\n11. Adequate major organ and bone marrow function;\n12. Women or men of childbearing potential must use highly effective contraception.\n\n1\\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;\n2. Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;\n3. T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and\u002For bulky N2 disease;\n4. Eligible only for segmentectomy or wedge resection;\n5. Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;\n6. Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;\n7. History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);\n8. History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);\n9. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;\n10. Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);\n11. Active or prior history of interstitial lung disease (ILD)\u002Fpneumonitis;\n12. Expected to receive live vaccine therapy within 30 days after randomization;\n13. History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;\n14. Pregnant or lactating women;",{"count":345,"type":21},120,[72],"To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.",[96],"2025-11-30",{"date":351,"type":32},"2025-12-05",{"date":349,"type":21},{"date":354,"type":21},"2032-06-30",{"name":38,"class":39},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":4},"100612244","phase-2-a-study-of-sys6010-enlonstobart-and-chemotherapy-for-first-line-treatment-of-esophageal-squamous-cell-carcinoma-100612244","NCT07251062","A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.","A Phase II\u002FIII Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU\u002FCapecitabine in Subjects With First-Line Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written ICF;\n2. Age 18-75 (inclusive) years, male or female;\n3. With histologically\u002Fcytologically confirmed esophageal squamous cell carcinoma that is either locally advanced unresectable or metastatic, with no prior systemic antitumor therapy administered for the recurrent\u002Fmetastatic disease setting. Have at least one measurable lesion that meets the RECIST v 1.1 criteria at baseline;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;\n5. Life expectancy ≥ 3 months;\n\nExclusion Criteria:\n\n1. Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);\n2. Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory\u002Fco-inhibitory pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 antibodies)\n3. With a history of ≥Grade 3 allergic reactions to monoclonal antibodies, or with known hypersensitivity or intolerance to SYS6010, SG001, paclitaxel, carboplatin, cisplatin, fluorouracil, or any of their excipients;\n4. With dihydropyrimidine dehydrogenase (DPD) deficiency.",{"count":364,"type":21},737,[72,24],"This is a multicenter phase 2\u002F3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU\u002FCapecitabine as first-line treatment, in patients with advanced\u002Fmetastatic esophageal squamous cell carcinoma.",[368],"Esophageal Squamous Cell Carcinoma","2025-11-18",{"date":371,"type":32},"2025-11-26",{"date":373,"type":21},"2025-12-30",{"date":375,"type":21},"2030-12-30",{"name":38,"class":39},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":238,"minAge":17,"maxAge":18,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":4},"100610672","phase-3-sys6002-vs-chemotherapy-in-recurrent-or-metastatic-cervical-cancer-100610672","NCT07230626","SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer","A Randomized, Open-Label, Controlled, Multicenter Phase 3 Trial of SYS6002 Versus Chemotherapy of Physician's Choice in Recurrent or Metastatic Cervical Cancer After Platinum-containing Chemotherapy and Anti-PD-(L)1 Agent Therapy","Inclusion Criteria:\n\n* 1\\. Patients aged 18-75 years (inclusive);\n* 2\\. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent;\n* 3\\. Subject must have received a platinum-based chemotherapy with anti-PD-(L)1 agent and if was received administered in the adjuvant\u002Fneoadjuvant setting subject must have progressed during treatment or within 6 months of treatment completion；received no more than 2 prior systemic therapy in the metastatic\u002Frecurrent setting; must have experienced radiographic progression during or after the last treatment regimen;\n* 4\\. An archival tumor tissue sample or a fresh tissue sample should be provided;\n* 5\\. Subjects must have measurable disease according to RECIST (version 1.1);\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 7\\. Life expectancy of ≥ 3 months;\n* 8\\. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n* 9.Sexually active fertile subjects must agree to use methods of contraception during the study and at least7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 10.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Has other histologies not mentioned as part of the inclusion criteria 2;\n* 2\\. Active central nervous system metastases or leptomeningeal metastasis;\n* 3\\. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；\n* 4\\. Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's particiation in the study:\n\n  1. Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period; Cerebrovascular Accident; Participants with poorly controlled hypertension on medication, with systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg;\n  2. Other clinically significant diseases:\n\nHbA1c \\> 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifunga therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; History of genital tract fistula, except for whose perforations or fistulas that have been treated with resection or repair, and are considered by the investigator to be healed or in remission; Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n\n* 5\\. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;\n* 6\\. Allergy to any component of SYS6002, or humanized monoclonal antibodies;\n* 7\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":385,"type":21},412,[24],"This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1\u002FL1 inhibitor therapy",[389],"Cervical Cancer","2025-11-13",{"date":392,"type":32},"2025-11-17",{"date":394,"type":21},"2025-11-20",{"date":396,"type":21},"2028-07-01",{"name":38,"class":39},{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100592149","phase-2-sys6002-plus-jmt101-and-enlonstobart-injection-in-participants-with-hnscc-100592149","NCT06989671","SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC","A Phase 2 Study of SYS6002 in Combination With JMT101 and Enlonstobart Injection in Participants With Recurrent and\u002For Metastatic Head and Neck Squamous Cell Cancer (HNSCC)","Inclusion Criteria:\n\n* Aged 18 years or older, regardless of gender.\n* Able to understand and voluntarily sign a written informed consent form (ICF).\n* Confirmed recurrent or metastatic HNSCC that is not curable with local treatments. Primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.\n* Able to provide well-preserved or fresh tumor tissue.\n* According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, at least one measurable lesion confirmed by CT or MRI.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy ≥ 3 months.\n* Normal major organ function within 7 days prior to treatment.\n\nExclusion Criteria:\n\n* Primary tumor located in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or squamous cell carcinoma with an unknown primary site.\n* Presence of leptomeningeal metastasis, spinal cord compression, symptomatic or progressive brain metastases.\n* (Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.\n* Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.\n* Participants who have previously received MMAE toxin ADC treatment (only for Part 1 and Stage 2 in Part 2).\n* Adverse events related to prior anti-tumor treatment that have not resolved to ≤ Grade 1 according to NCI-CTCAE v5.0 (except for toxicities deemed low-risk by the investigator, such as Grade 2 alopecia).\n* Washout period not met for anti-tumor medications or treatments.\n* Any serious and\u002For uncontrolled comorbid conditions that may interfere with the participant's ability to participate in the study\n* Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test within 7 days before enrollment. Breastfeeding women may participate if they stop breastfeeding, but they cannot resume breastfeeding during the treatment and after the study ends.\n* Any male or female participants of childbearing potential who refuse to use highly effective contraception during the study and for 6 months after the last dose of study drug.\n* Unwilling or unable to comply with the study procedures and requirements, or deemed unsuitable for participation by the investigator.",{"count":406,"type":21},430,[72],"This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.",[285],"2025-08-20",{"date":412,"type":32},"2025-08-27",{"date":414,"type":21},"2025-08-30",{"date":416,"type":21},"2028-07-30",{"name":38,"class":39},{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100601468","phase-1-a-clinical-study-of-sys6023-in-patients-with-advanced-solid-tumors-100601468","NCT07110883","A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically and\u002For cytologically confirmed locally advanced unresectable or metastatic malignant solid tumor;\n3. Sufficient archived or fresh tumor tissue samples must be provided for HER3 testing, among others;\n4. Medical documentation must be provided before the first dose to clarify the following molecular typing information: HER2, HR receptor (including estrogen receptor (ER) and progesterone receptor (PR) ) expression for breast cancer participants, and Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, serine\u002Fthreonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, Neurotrophic Tyrosine Receptor Kinase (RET) rearrangement, HER2 mutation, MET Proto-Oncogene（Met）exon14 skipping mutation, Met amplification, KRAS Proto-Oncogene, GTPase G12C（KRAS G12c） mutation status for non-small cell lung cancer (NSCLC) participants;\n5. Depending on the trial phase, the following requirements must be met:\n\n   * \\*\\*Cohort Expansion Phase:\\*\\*\n   * \\*\\*Cohort A:\\*\\* HER3+ (by central lab), HR+\u002FHER2- (HR+ defined as expressing estrogen receptor (ER), with or without progesterone receptor (PR) co-expression), locally advanced or metastatic breast cancer, previously treated with at least one line of systemic therapy including endocrine and CDK4\u002F6 inhibitor treatment.\n   * \\*\\*Cohort B:\\*\\* EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer, previously treated with at least one line of systemic therapy, including EGFR Tyrosine Kinase Inhibitor (TKI) and platinum-based chemotherapy.\n   * \\*\\*Cohort C:\\*\\* HER3+ (by central lab), HER2+, locally advanced or metastatic breast cancer, previously treated with at least two lines of anti-HER2 systemic therapy including trastuzumab, taxane, and T-DM1 or TKI.\n   * \\*\\*Cohort D:\\*\\* HER3+ (by central lab), platinum-resistant recurrent ovarian cancer (defined as disease progression within \\>3 months and ≤6 months after last platinum-based chemotherapy for first-line, or within 6 months for second-line or higher lines of platinum-based chemotherapy), and non-platinum refractory (defined as disease progression within 4 weeks after last platinum-based chemotherapy).\n   * \\*\\*Cohort E:\\*\\* Other driver gene-positive (e.g., ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, RET rearrangement, HER2 mutation, Met exon 14 skipping mutation, Met amplification, KRAS G12c mutation, etc.), locally advanced or metastatic non-small cell lung cancer, previously treated with corresponding targeted TKI therapy.\n   * \\*\\*Cohort F:\\*\\* other HER3+ (by central lab) tumor types (including but not limited to triple negative breast cancer (TNBC), driver gene mutation-negative NSCLC, prostate cancer, etc.) which may potentially benefit from this treatment, or known NRG1 fusion tumors, both of which have previously treated with at least one line of systemic therapy.\n6. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST)1.1 criteria;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n8. Expected survival of at least 3 months;\n9. Adequate organ function, with laboratory test results meeting the following criteria (no blood transfusions, Erythropoietin, Erythropoietin, or other medical support treatments within 14 days before testing):\n\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   * Platelet ≥ 100 × 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Total Bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or TBIL ≤ 3 × ULN for participants with liver metastasis, liver cancer, or Gilbert's syndrome\n   * Aspartate Aminotransferase (ALT) and Alanine Aminotransferase (AST) ≤ 2.5 × ULN, or ALT and AST ≤ 5 × ULN for participants with liver metastasis or liver cancer\n   * Creatinine clearance (Ccr) \\> 50 mL\u002Fmin (calculated using Cockcroft-Gault formula)\n   * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN\n   * Left ventricular ejection fraction (LVEF) ≥ 50%\n10. Fertile participants (both male and female) must agree to use reliable contraceptive methods (hormonal contraception, barrier methods, or abstinence) during the trial and for at least 6 months after the last dose; female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment;\n11. Fully understand the clinical trial and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Known symptomatic central nervous system or meningeal metastases, or other evidence of uncontrolled central nervous system or meningeal metastases as judged by the investigator; stable central nervous system or meningeal metastases are allowed; 2. Previous treatment with HER3-targeting ADC; 3. Adverse reactions from previous anti-tumor treatments that have not recovered to ≤ Grade 1 according to CTCAE 5.0 (excluding toxicities deemed not a safety risk by the investigator, such as alopecia); 4. Receipt of antibody-based macromolecule therapy, definitive radiotherapy, immunotherapy within 28 days before the first dose, or chemotherapy, small molecule targeted therapy, palliative radiotherapy, hormone therapy, or traditional Chinese medicine with anti-tumor indication effects within 14 days or 5 half-lives (whichever is longer) before the first dose; 5. Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial or in the follow-up period of an interventional trial; 6. Receipt of major surgery or invasive intervention within 28 days before the first dose; 7. Known severe allergic reactions to the investigational intervention or any of its components or excipients; 8. Active bacterial, fungal, or viral infection requiring intravenous antibacterial, antifungal, or antiviral treatment before the first dose. Participants receiving prophylactic infection treatment without active infection symptoms may be considered for inclusion; 9. Uncontrolled serous cavity effusion (e.g., pleural effusion, ascites, pericardial effusion, etc.) requiring frequent drainage or medical intervention within 7 days before the first dose, excluding exfoliation cytology of exudate; 10. History of immunodeficiency, including Human immunodeficiency virus (HIV) antibody positivity; 11. Hepatitis B Surface Antigen (HBsAg) positive with Hepatitis B Virus (HBV)-DNA higher than the lower limit of detection or 1000 copies\u002FmL (500 IU\u002FmL) (whichever is lower), Hepatitis C virus (HCV) antibody positive with HCV-RNA higher than the lower limit of detection or 1000 copies\u002FmL (whichever is lower); 12. Severe cardiovascular disease history, including but not limited to:\n* Severe cardiac arrhythmia or conduction abnormality requiring clinical intervention, such as ventricular arrhythmia, grade II-III atrioventricular block, etc.;\n* Average QT interval corrected by Fridericia's formula (QTcF) \\> 450 ms on three resting 12-lead Electrocardiogram;\n* Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months before the first dose;\n* New York Heart Association (NYHA) classification ≥ Class II;\n* Any factors increasing the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relatives under 40 years old, concomitant use of drugs known to prolong QT interval;\n* Uncontrolled hypertension (screening systolic BP ≥ 160 mmHg and\u002For diastolic Blood Pressure (BP) ≥ 100 mmHg); 13. Drug-induced colitis, or history of hormone-requiring interstitial lung disease\u002Fpneumonitis or current suspicion of interstitial lung disease\u002Fpneumonitis on screening imaging; 14. Evidence of gastrointestinal bleeding or perforation risk, or pyloric obstruction, persistent recurrent vomiting (defined as vomiting ≥ 3 times within 24 hours), deemed unsuitable for inclusion by the investigator; 15. Use of or need for strong Recombinant Human CYP3A4 Enzyme (CYP3A4) inducers or inhibitors, Organic Anion Transporting Polypeptides 1B1 (OATP1B1) or Organic Anion Transporting Polypeptides 1B3 (OATP1B3) inhibitors within 5 half-lives before the first dose or during the study; 16. Current psychiatric disorder affecting compliance; 17. Exclusion of those on long-term immunosuppressive therapy or requiring daily systemic steroid treatment, except for topical glucocorticoid treatment via nasal, inhalation, or other routes; 18. Pregnant or breastfeeding women; 19. Other reasons deemed unsuitable for participation by the investigator.",{"count":260,"type":21},[114],"This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.",[429],"Advanced Solid Tumor","2025-08-01",{"date":432,"type":32},"2025-08-08",{"date":434,"type":32},"2024-08-15",{"date":436,"type":21},"2028-10-31",{"name":38,"class":39},2,{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":40},"100589766","phase-1-evaluation-of-sys6005-in-patients-with-advanced-malignant-tumor-100589766","NCT06958679","Evaluation of SYS6005 in Patients With Advanced Malignant Tumor","A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Anti-tumor Activity of SYS6005 in Patients With Advanced Malignant Tumor","Inclusion Criteria:\n\n1. Participants who are voluntarily enrolled in this study and sign the informed consent form (ICF);\n2. Age ≥ 18 years old, male or female;\n3. Patients with advanced malignant tumors confirmed by cytology or histology, who have failed standard therapy or are intolerant to standard therapy and require systemic treatment： Solid tumor: Pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy. Preferred tumor types include breast, lung, gynecologic, prostate, skin, adrenal, testicular, colon, bladder, pancreatic, gastric, kidney, cholangiocarcinoma, and esophageal cancers.\n\n   B-cell malignancies: Pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 WHO classification, with disease progression on or after at least 2 lines of prior systemic therapy. Preferred tumor types include cHL, DLBCL, MCL, FL, MZL, RTL, CLL\u002FSLL;\n4. Patients with at least one evaluable lesion as defined per RECIST v1.1 for solid tumor or 2014 Lugano Classification Criteria for lymphoma, respectively;\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2;\n6. Expected survival ≥ 3 months;\n7. Participants must have adequate organ function and have not received transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medical supportive treatments within 14 days prior to examination\n8. For participants enrolled in the dose-expansion phase, tumor tissue must be confirmed as ROR1-positive by the central laboratory during screening in order to be eligible for enrollment.\n9. Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the ICF until at least 6 months after the last dose of the investigational product; female participants of childbearing potential must have a negative pregnancy test result within 7 days prior to the first administration of the investigational product;\n10. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Participants who have participated in other studies involving ROR1-targeted therapies prior to enrollment in this study, or have previously received ADC treatments containing MMAE payloads;\n2. Participants with known central nervous system (CNS) lymphoma or CNS metastases from solid tumors that are symptomatic, untreated, or require treatment. Except for participants with metastases to CNS that have been completely resected and\u002For have stabilized or improved after radiotherapy, provided that imaging examinations prior to screening show stable disease for at least 4 weeks, and there is no evidence of brain oedema and no requirement for corticosteroids or anticonvulsant drugs;\n3. Participants deemed suitable for CAR-T therapy or hematopoietic stem cell transplant (HSCT) by the investigator. Participants who have received an allogeneic haematopoietic stem cell transplant within 6 months prior to the first administration of the investigational product, have received an autologous haematopoietic stem cell transplant within 100 days prior to the first administration of the investigational product, or have received CAR-T cell therapy within 3 months prior to the first administration of the investigational product. Participants with active graft versus host disease;\n4. Participants have a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast or cancers that have been treated with no expectation of recurrence\n5. Participants have a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy For solid tumor: \\> 10 mg daily prednisone equivalents within 14 days prior to the administration of the first dose of SYS6005; For lymphoma: \\> 20 mg daily prednisone equivalents within 28 days prior to the administration of the first dose of SYS6005; The use of short-course systemic corticosteroids (≤ 7 days) is permitted, with a wash-out period of 1 week prior to the administration of the first dose of SYS6005\n6. Participants with peripheral oedema, pericardial effusion, pleural effusion, or ascites that require medical intervention or limit daily life activities;\n7. Participants with records of cerebrovascular events, angina unstable, myocardial infarction, or a history of NYHA Class III-IV cardiac symptoms within 6 months before the first administration of the investigational product, or a QTcF \\> 450 ms recorded in three repeated ECG examinations during screening;\n8. Participants with any active infection requiring systemic treatment within 2 weeks prior to the first dose of investigational product;\n9. Participants who have used strong inhibitors or inducers of CYP3A4 within 7 days prior to the first dose of the investigational product, or are expected to require the use of strong inhibitors or inducers of CYP3A4 during the study treatment;\n10. Participants with the severity of any toxicities from prior treatments or surgery (excluding ≤ Grade 2 alopecia, endocrine disorders manageable with hormone replacement therapy, or other toxicities that the investigator considers do not pose a safety risk to the patient) has not returned to baseline or ≤ Grade 1 per NCI-CTCAE Version 5.0;\n11. Participants with ≥ grade 2 peripheral neuropathy at baseline;\n12. Participants who have received major surgery, radical radiotherapy, antibody-based targeted therapy, or immunotherapy within 28 days prior to the first administration of the investigational product, or who have received palliative radiation, chemotherapy, or small molecule targeted therapy within 14 days prior to the study treatment. Participants who have used anti-tumor Chinese herbal preparations or Chinese patent medicines within 14 days prior to the first administration of the investigational product;\n13. Participants with history of immunodeficiency or positive human immunodeficiency virus (HIV) antibody test during screening;\n14. Participants with active hepatitis B or hepatitis C, where active hepatitis B is defined as HBsAg positive and HBV DNA \\> 2000 IU\u002Fml; active hepatitis C is defined as HCV antibody positive and HCV RNA \\> ULN;\n15. Participants who have received a live vaccine within 28 days prior to the first dose of investigational product;\n16. Participants with history of hypersensitivity or atopic reactions to excipients of the investigational product or any monoclonal antibodies;\n17. Women who are pregnant or breastfeeding;\n18. Other situations that may interfere with the participant's participation in the study program or are not in the participant's best interest or affect the study results include: history of mental illness, addiction or drug abuse, any other clinically significant illness or condition, etc.",{"count":447,"type":21},132,[114],"This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)\u002Frecommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.",[451,452],"B-cell Malignancies","Solid Tumors","2025-05-12",{"date":455,"type":32},"2025-05-14",{"date":457,"type":32},"2025-04-03",{"date":166,"type":21},{"name":38,"class":39},{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":40},"100590697","phase-1-a-study-of-sys6040-for-injection-in-patients-with-advanced-solid-tumors-100590697","NCT06970795","A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors","An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1）Aged ≥18 years; 2) Subjects with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no options of standard of care. During cohort expansion, subjects will be enrolled as follows: Cohort 1: SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen; Cohort 2: Subjects with DLL3-positive malignant solid tumors who failed standard therapy, are intolerant to standard therapy, or have no options of standard of care.\n\n3\\) At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4) ECOG score of 0 or 1; 5) Life expectancy ≥3 months; 6) Laboratory parameters meeting the following criteria:\n\n1. Neutrophil count ≥1.5×109\u002FL;\n2. Platelet count ≥100×109\u002FL;\n3. Hemoglobin ≥9 g\u002FdL;\n4. Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (In cases with liver metastases: total bilirubin ≤3×ULN and ALT\u002FAST ≤5×ULN);\n5. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin;\n6. International Standardized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.\n\na. Fertile males and females must use reliable contraception throughout the study period and for 9 months after the last dose. Females aged 18-60 years must have negative blood pregnancy results within 7 days before the first dose.\n\n7\\) Understand and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Having received systemic antitumor therapy within 4 weeks before first dose, including: Chemotherapy, macromolecular targeted therapy, antiangiogenic therapy, biotherapy, immunotherapy, radiotherapy (except palliative radiotherapy for bone metastasis pain relief), except:\n\n   1. Oral fluorouracil agents and small molecule targeted drugs within 2 weeks before first dose or within 5 half-lives (whichever is longer);\n   2. Traditional Chinese medicines with antitumor indications within 2 weeks before first dose.\n2. Used or required to use strong CYP3A4 inhibitors\u002Finducers within 2 weeks before first dose or during the study;\n3. Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;\n4. Having received systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily for \\>7 days) or other immunosuppressants within 2 weeks before treatment initiation (inhaled\u002Ftopical steroids or adrenal replacement therapy \\>10 mg prednisone equivalent permitted without active autoimmune disease);\n5. Having received transfusion, EPO, TPO, IL-11, G-CSF or GM-CSF therapy within 2 weeks before first dose;\n6. Having used or required to use QT-prolonging\u002Fshortening drugs within 7 days before first dose or during C-QTc study period, or have risk factors for QT prolongation\u002Farrhythmia (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives \\\u003C40 years);\n7. Severe cardiovascular\u002Fcerebrovascular disease history；\n8. History of other primary malignancies (except cured localized tumors like basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate\u002Fcervix\u002Fbreast, or subjects with other primary tumors showing no recurrence for ≥5 years);\n9. Clinically confirmed active pneumonia at screening or history of interstitial lung disease;\n10. Uncontrolled serous effusions requiring frequent drainage or medical intervention at screening (e.g., pleural\u002Fperitoneal\u002Fpericardial effusions needing additional intervention within 2 weeks after initial treatment, excluding cytological examination);\n11. Brain metastases or spinal cord compression at screening (except those completing local therapy with ≥4-week steroid discontinuation and stable imaging\u002Fneurological symptoms for ≥4 weeks before treatment initiation);\n12. Severe unhealed wounds\u002Fulcers\u002Ffractures, or major surgery within 4 weeks before first dose, or planned elective surgery during study;\n13. Clinically confirmed active HBV or HCV.Active HBV definition: HBcAb or HBsAg positive with HBV DNA above ULN; Active HCV definition: HCV antibody positive with HCV RNA above ULN;\n14. Active tuberculosis confirmed clinically, or TP-Ab positive, or HIV-Ab positive, or history of immunodeficiency diseases\u002Forgan transplantation\u002Fallogeneic hematopoietic stem cell transplantation;\n15. Significant bleeding tendency within 4 weeks before first dose, investigator-assessed high-risk of gastrointestinal hemorrhage\u002Fhemoptysis, or congenital bleeding disorders\u002Fcoagulopathy;\n16. Active infection requiring medication or unexplained fever ≥38.5°C during screening;\n17. History of psychotropic substance abuse, alcoholism, or drug addiction;\n18. Pregnancy or lactation at screening;\n19. Persistent adverse reactions from prior antitumor therapy not recovered to CTCAE v5.0 ≤Grade 1 or baseline (except alopecia\u002Fnail changes\u002Fother investigator-deemed non-safety concerns);\n20. Investigator-determined ineligibility for study participation.",{"count":468,"type":21},180,[114],"This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.",[472,473],"Small Cell Lung Cancer","Other Advanced Solid Tumors","2025-05-06",{"date":455,"type":32},{"date":477,"type":32},"2025-04-10",{"date":479,"type":21},"2028-11-30",{"name":38,"class":39},{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":322,"sex":16,"minAge":323,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":4},"100589469","phase-1-safety-and-immunogenicity-of-sys6017-in-healthy-participants-aged-40-years-or-more-100589469","NCT06954818","Safety and Immunogenicity of SYS6017 in Healthy Participants Aged 40 Years or More","A Randomized, Observer-blind, Placebo-controlled, Adaptive Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6017(a Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years or More","Inclusion Criteria:\n\n* 1\\. Healthy participants aged 40 years or more;\n* 2\\. Be able to understand the study procedures and comply with the requirements of the protocol for the scheduled visits, voluntarily consent to participate in the study and sign the informed consent form (ICF);\n* 3\\. Being in good health at the discretion of investigators based on medical history inquiry, physical examination, laboratory test and electrocardiograph examination;\n* 4\\. For female participants of childbearing potential: no sexual activity or used effective contraceptive methods within one menstrual cycle before enrollment; no pregnancy plans and agree to used effective contraceptive methods with 8 months after enrollment.\n\nExclusion Criteria:\n\n* 1\\. History of zoster;\n* 2\\. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);\n* 3\\. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;\n* 4\\. Have abnormal test or examination result that is of Grade 1 (inclusive) or more in accordance with the Guidelines for Adverse Event Grading Standards for Clinical Trials of Preventive Vaccines (2019) issued by China National Medical Products Administration or other applicable adverse event grading standards referred in the protocol;\n* 5\\. History of allergy to any component of the investigational vaccine, or history of severe allergic reaction (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenia purpura or Arthus reaction) to vaccines or medicines;\n* 6\\. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that would increase the risk of myocarditis or pericarditis;\n* 7\\. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.\n* 8\\. Current epilepsy or convulsion, severe neurological or psychiatric disorders;\n* 9\\. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or current treatment with anticoagulants, etc;\n* 10\\. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;\n* 11\\. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;\n* 12\\. Have diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy;\n* 13\\. Have received immunosuppressants, immunostimulants, or other immunomodulatory medicines (e.g., corticosteroids, ≥ 20 mg\u002Fd prednisone or equivalent) for a long time (defined as 14 days or more), within 6 months before enrollment, or planning to receive the aforementioned medicines during the study; inhaled and topical steroids are allowed;\n* 14\\. Have received whole blood, plasma, serum, immunoglobulins, or monoclonal antibodies within 3 months before enrollment, or planning to receive these products during the study;\n* 15\\. Blood donation or blood loss ≥ 450 mL within 1 month before enrollment, or planning to donate blood during the study;\n* 16\\. Have received any other vaccine within 30 days before enrollment, or planning to receive any other vaccine within 30 days after the last dose;\n* 17\\. Currently participating in or planning to participate in other clinical trials during the study;\n* 18\\. For female participant of childbearing potential: having positive urine pregnancy test, being in pregnancy or lactation before enrollment;\n* 19\\. Unable to comply with the study procedures or adhere to the study requirements, or there are other conditions that make the participation in this study inappropriate, as determined by the investigators.",{"count":489,"type":21},200,[114],"Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. This randomized, observer-blind, placebo-controlled, adaptive phase 1 trial aims to evaluate the safety and immunogenicity of an investigational zoster mRNA vaccine in healthy participants aged 40 years or more.",[329],"2025-05-05",{"date":495,"type":32},"2025-05-08",{"date":497,"type":21},"2025-05-10",{"date":499,"type":21},"2026-11-10",{"name":38,"class":39},{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":4},"100575665","phase-1-clinical-trial-of-sys6010syh2051-versus-chemotherapy-in-advanced-breast-cancer-and-other-solid-tumors-100575665","NCT06775236","Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors","A Phase 1b\u002F2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years. 2. Phase 1b\u002FPhase 2: Breast cancer (no tumor type restriction during the combination dose escalation phase).\n\n  3\\. Provide tumor tissue samples for immunohistochemical EGFR expression testing, with EGFR expression positive as confirmed by the central laboratory.\n\n  4\\. At least one measurable extracranial lesion according to RECIST v1.1 criteria (no requirement during the combination dose escalation phase of Phase 1b).\n\n  5\\. ECOG performance status score of 0-1. 6. Expected survival ≥ 3 months. 7. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment.\n\n  8\\. Subject agrees to use effective contraception from the time of signing the informed consent form until 6 months after the last dose.\n\n  9\\. Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable brain metastases are eligible for inclusion.\n\n  2\\. Previously diagnosed HER2-positive breast cancer (IHC 3+ or ISH positive) (Applicable to Phase 1b Group C and Phase 2).\n\n  3\\. Previously treated with antibody-drug conjugates (ADC) containing topoisomerase I inhibitors (Applicable to Phase 1b Group C and Phase 2).\n\n  4\\. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies.\n\n  5\\. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies (This is a repeat of criteria #4).\n\n  6\\. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk).\n\n  7\\. Failure to meet the required washout period for prior medications or treatments as specified in the protocol.\n\n  8\\. History of severe cardiovascular or cerebrovascular diseases. 9. History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these conditions.\n\n  10\\. Thyroid dysfunction requiring medication, unless the condition is controlled by medication and no dose adjustments are needed.\n\n  11\\. Severe infection within 4 weeks prior to the first use of the investigational drug.\n\n  12\\. History of discontinuing EGFR-targeted therapy for ≥ 1 month due to skin toxicity, or current skin conditions requiring medication.\n\n  13\\. Gastrointestinal diseases or functional impairments that may significantly affect the absorption of the investigational drug (e.g., ulcerative disease, severe nausea\u002Fvomiting, diarrhea, malabsorption, etc.).\n\n  14\\. Uncontrolled pleural or peritoneal effusion. 15. Active HBV or HCV infection, syphilis, HIV infection, or AIDS. 16. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":509,"type":21},410,[114,72],"The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Phase 2 aims to assess the efficacy and safety of SYS6010 monotherapy or in combination with SYH2051 compared to investigator-selected chemotherapy in patients with EGFR-expressing, unresectable locally advanced or metastatic advanced breast cancer.",[117,513],"Breast Cancer","2025-03-17",{"date":516,"type":32},"2025-03-19",{"date":518,"type":21},"2025-03-20",{"date":520,"type":21},"2028-01-15",{"name":38,"class":39},""]