[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"3D Medicines (Sichuan) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,66,88,108,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100525593","phase-3-phase-iii-study-of-envafolimab-versus-placebo-plus-chemotherapy-in-resectable-stage-iii-nsclc-100525593",false,"NCT06123754","Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC","A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent form.\n2. Age ≥ 18 years old, regardless of gender.\n3. Histological and\u002For cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.\n4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Subjects should provide tumor tissue for detection of PD-L1 expression level.\n7. Sufficient organ and bone marrow function.\n8. Expected survival ≥6 months.\n9. The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.\n\nExclusion Criteria:\n\n1. Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous\u002Fsarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.\n2. Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);\n3. Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;\n4. Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.\n5. Previous anti-tumor therapy for the disease.\n6. Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.\n7. Any serious active infection.\n8. With uncontrolled or significant cardiovascular and cerebrovascular disease.\n9. Active autoimmune disease requiring systemic treatment.\n10. Immunosuppressant or systemic hormone therapy (dose \\>10 mg\u002F day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.","ALL","18 Years",{"count":19,"type":20},390,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant\u002Fadjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.",[26],"Non-small Cell Lung Cancer",[28],"Envafolimab","RECRUITING","2026-03-23",{"date":32,"type":33},"2026-03-25","ACTUAL",{"date":35,"type":33},"2023-11-17",{"date":37,"type":20},"2027-12-30",{"name":39,"class":40},"3D Medicines (Sichuan) Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100447941","phase-2-study-of-envafolimab-alone-or-with-lenvatinib-in-patients-with-advanced-endometrial-cancer-100447941","NCT05112991","Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent form.\n2. Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has Documented evidence of advanced, recurrent or metastatic EC and are not candidates for curative surgery or radiation.\n3. Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.\n\n   Note: If recurrence occurs during adjuvant\u002Fneoadjuvant therapy or within 12 months after completion, adjuvant\u002Fneoadjuvant therapy is considered to be the first-line treatment for advanced disease. There is no restriction regarding prior hormonal therapy.\n4. Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blind Independent Imaging Review Committee (BIRC).\n5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy of 12 weeks or more.\n7. Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 14 days before the first study drug treatment).\n8. Archival tumor tissue or a newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis. Tissue samples need to be from lesions that have not received local radiotherapy.\n9. Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.\n\nExclusion Criteria:\n\n1. Previous lab results showed dMMR or MSI-H.\n2. Participate in the clinical trials of other investigational drugs within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy or targeted therapy.\n3. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.\n4. Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.\n5. Has received prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n6. Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as BP \\>150\u002F90 mmHg.\n7. Uncontrolled or major Cardio-cerebral vascular disease.\n8. Have active, or have had autoimmune diseases or risks that may recur. However, subjects required only replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or with skin diseases that do not require systemic treatmentare are allowed to be included.\n9. Subjects who need to use corticosteroids (\\> 10 mg\u002Fday prednisone equivalent dose) for systemic therapy within 14 days before the study drug is administered.\n10. Has received a live-virus vaccination within 28 days of planned treatment start or plan to reveived a live-virus vaccination during the study.\n11. Has current or suspected (non-infectious) pneumonitis.\n12. Active infection (any infection requiring systemic treatment).\n13. Has active Hepatitis B or C.\n14. Is positive for Human Immunodeficiency Virus (HIV).\n15. Has uncontrolled pericardial effusion, pleural effusion or ascites.\n16. Has symptomatic\u002Factive brain metastasis or meningeal carcinomatosis; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.\n17. Suffered from other known malignant tumors within 5 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and\u002For carcinoma in situ after radical resection).\n18. Hypersensitivity to either of the study drug or its components.\n19. Females who are pregnant or breastfeeding and who refuse to use a highly effective method of contraception throughout the entire study period, and for 6 months after the last dose of study drug;\n20. According to the judgement of the investigators, there are other factors indicate that the subject should not be enrolled.\n21. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis.\n22. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n23. Has a history of hypertensive crisis or hypertensive encephalopathy.\n24. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n25. Has a history of serious bleeding disease within 6 months prior to the first dose of study drug.","FEMALE",{"count":51,"type":20},108,[53],"PHASE2","This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.",[56],"Advanced Endometrial Cancer",[58],"endometrial cancer",{"date":32,"type":33},{"date":61,"type":33},"2022-03-04",{"date":63,"type":20},"2026-12",{"name":39,"class":40},19,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":87},"100441121","phase-1-phase-ibii-trial-of-envafolimab-plus-lenvatinib-for-subjects-with-solid-tumors-100441121","NCT05024214","Phase Ib\u002FII Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors","Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib\u002FII Study","Inclusion Criteria:\n\n1. Eighteen years and older;\n2. phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carcinoma) that have progressed after standard treatment or are intolerant or have no effective treatment;\n3. phase II cohort 1:Histological or cytological diagnosis of NSCLC，RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system treatment lines≤2;\n4. phase II cohort 2：Unresectable locally advanced or metastatic or recurrent RCC;\n5. Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced\u002Fmetastatic disease must be provided, and if biopsies are not available, samples obtained prior to receiving adjuvant\u002Fneoadjuvant chemotherapy are allowed;\n6. phase Ib and phase II cohort 1: Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) assessment ≥70；\n7. Life expectancy of at least 12 weeks;\n8. At least one measurable lesion per RECIST 1.1;\n9. Adequate organ function;\n10. Signed informed consent.\n\nExclusion Criteria:\n\n1. Prior anticancer treatment within 4 weeks prior to the first dose of study drugs;\n2. Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1;\n3. Hypertension did not satisfactory controlled after antihypertensive medication\n4. Phase Ib\u002FII: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib\n5. Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib\u002FSunitinib;\n6. Uncontrollable or significant cardiovascular or cerebrovascular disease;\n7. Active, known history or suspected autoimmune disease;\n8. Have used or require treatment with \\>10 mg\u002Fday of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs;\n9. have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period;\n10. Subjects with known or suspected interstitial pneumonia;\n11. Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)\n12. Active hepatitis B or hepatitis C;\n13. Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy;\n14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;\n15. Known active or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis;\n16. Have other primary malignancies within 5 years;\n17. Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients\n18. Women who are pregnant or breastfeeding.\n19. Radiographic evidence of major blood vessel invasion\u002Finfiltration may be considered for enrollment if the investigator assesses that the risk is manageable.",{"count":74,"type":20},170,[76,53],"PHASE1","This is an open-label, multi-center study of Phase Ib\u002FII study to assess the efficacy and safety of Envafolimab combinded with Lenvatinib in the treatment of subjects with advanced solid tumors. The primary hypothesis of this study is that subjects will have a better objective response rate (ORR) when treated with Envafolimab plus Lenvatinib than SOC.",[79,26,80,81],"Solid Tumors","Renal Cell Carcinoma","Hepatocellular Carcinoma",{"date":32,"type":33},{"date":84,"type":33},"2021-11-15",{"date":63,"type":20},{"name":39,"class":40},23,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100432382","phase-2-multicenter-phase-2-study-of-envafolimab-in-biliary-tract-cancers-100432382","NCT04910386","Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers","A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers","Inclusion Criteria:\n\n1. Be ≥ 18 years of age;\n2. Subjects must have a histopathological or cytological diagnosis of locally advanced or metastatic gallbladder cancer (GBC) or cholangiocarcinoma (CCA);\n3. Subjects who have not received prior systemic therapy for advanced disease or who have received adjuvant or neoadjuvant chemotherapy in one regimen and relapsed \\> 6 months after the end of chemotherapy can be enrolled;\n4. Child-Pugh liver function rating: class A (5-6 points) and better class B (7 points) (see Appendix 3);\n5. ECOG PS score 0 or 1 (see Appendix 1);\n6. Expected survival ≥ 12 weeks;\n7. Subjects with at least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);\n8. Subject must have adequate major organ and bone marrow functions (no blood transfusion and no use of hematopoietic growth factor within 14 days before the first dose of study treatment):\n\n1\\) Hematology: neutrophils ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 90 g\u002FL; 2) International normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 3) Liver function: serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\>1.5 ULN; Aspartate aminotransferase (AST \\[SGOT\\]) and alanine aminotransferase (ALT \\[SGPT\\]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastases; 4) Renal function: serum creatinine ≤ 1.5 x ULN and creatinine clearance (CCr) \\> 60 mL\u002Fmin (assessed with Cockcroft-Gault formula, see Appendix 6); 5) Normal cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.\n\n9\\. Subjects must fully understand the study, voluntarily participate, and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Has participated in another clinical trials of other investigational drugs or investigational devices within 4 weeks prior to the first dose of investigational product treatment (palliative radiotherapy for bone metastases completed at least 2 weeks prior to investigational product treatment is allowed);\n2. The investigator assesses liver metastases as 50% or more of the total liver volume;\n3. Has ascites requiring drainage or treatment with diuretics, or pleural or pericardial effusion requiring drainage and\u002For associated with symptoms of tachypnea within 4 weeks prior to the first dose of investigational product treatment;\n4. Has biliary obstruction with clinical intervention that has not resolved or requires anti-infective therapy as judged by the investigator 14 days prior to the first dose of investigational product treatment;\n5. Has prior liver transplantation;\n6. Has known active brain metastases or spinal cord compression; subjects with previously treated brain metastases may be enrolled if their clinical condition is stable and radiographic evidence shows no disease progression within 4 weeks prior to the first dose of investigational product treatment, and corticosteroid therapy is not required within 4 weeks prior to the first dose of investigational product treatment;\n7. Has a known additional malignant tumor in the past 5 years (except for skin basal cell or squamous cell carcinoma, or cervical, breast and other carcinoma in situ after radical surgery);\n8. Has received major surgical procedures (except biopsy) or incomplete healing of surgical wound within 4 weeks prior to the first dose of investigational product treatment;\n9. Has any unresolved toxicity (CTCAE Grade ≥ 2) from prior anti-tumor therapy, except for alopecia or Grade 2 peripheral neuropathy or other laboratory abnormalities that are not clinically significant as assessed by the investigator;\n10. Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma\u002Fatopy would be exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism that is stable on hormone replacement will not be excluded from the study;\n11. Has known history of HIV, or active bacterial or fungal infection requiring systemic treatment within 14 days prior to the first dose of investigational product treatment;\n12. Has history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or presence of active pneumonitis on chest CT scan within 4 weeks before the first dose of investigational product treatment;\n13. Has active hepatitis B (HBsAg positive and HBV-DNA ≥ 104 copies\u002FmL) or hepatitis C (HCV antibody positive and HCV-RNA quantitative test results greater than the lower limit of detection);\n14. Has a history or current evidence of clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina, acute ischemic\u002Fhemorrhagic stroke, congestive heart failure (≥ New York Heart Association Class II, see Appendix 4) within 6 months prior to enrollment; arrhythmias requiring treatment with other antiarrhythmic drugs in addition to β-blockers or digoxin; repeat QTcF interval \\> 450 milliseconds (ms) on ECG (see Appendix 5); hypertension not well controlled with antihypertensive drug therapy (systolic blood pressure \\> 150 mmHg, diastolic blood pressure \\> 100 mmHg);\n15. Be receiving therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg\u002Fday is allowed); or receiving antiplatelet anticoagulant therapy (aspirin doses ≤ 300 mg\u002Fday and clopidogrel doses ≤ 75 mg\u002Fday are allowed);\n16. Has received immunosuppressive drugs within 4 weeks prior to the first dose of investigational product treatment, excluding topical corticosteroids or systemic prednisone ≤ 10 mg\u002Fday or equivalent doses of other corticosteroids;\n17. Has received live vaccines within 4 weeks before the first dose of investigational product treatment or plan to receive it during the study;\n18. Has history of severe allergic reactions to chimeric or human antibodies or fusion proteins, or known allergies to biological products produced with Chinese hamster ovary cells or any component of envafolimab; known or suspected allergy to the chemotherapeutic drug gemcitabine\u002Fcisplatin and its components;\n19. Be pregnant or breastfeeding;\n20. Be childbearing potential but unwilling to accept effective contraceptive measures;\n21. Any other disease, metabolic disorder or laboratory abnormalities, that the investigator considers that the subject is not suitable for the investigational product treatment, or will affect the interpretation of the study results, or put the subject at high risk.",{"count":96,"type":20},126,[53],"This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers",[100],"Biliary Tract Neoplasms","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":104,"type":20},"2027-06-01",{"date":106,"type":20},"2029-12",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":41},"100430908","phase-2-envafolimab-single-agent-treatment-in-patients-with-advanced-solid-tumors-100430908","NCT04891198","ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors","An Open, Single-arm, Multi-center Phase II Clinical Study of ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent form.\n2. Age ≥ 18 years old, regardless of gender.\n3. Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology.\n4. Subjects with advanced malignant solid tumors who had disease progression or intolerance and no satisfactory alternative treatment with at least first-line standard treatment.\n\n   Note: If recurrence occurs during adjuvant\u002Fneoadjuvant therapy or within 6 months after completion, adjuvant\u002Fneoadjuvant therapy is considered to be the first-line treatment for advanced disease.\n5. Have not received immune checkpoint inhibitor treatment.\n6. Patients with the following tumor types: small cell lung cancer, cervical cancer, endometrial cancer, ovarian cancer, vulvar cancer, neuroendocrine tumors, salivary gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma, skin malignant melanoma , Merkel cell tumor, head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, bladder cancer, cholangiocarcinoma, etc.\n7. Have tissue and blood samples that can detect TMB specimen.\n8. There is at least one measurable lesion (RECIST 1.1 standard).\n9. ECOG score of 0 or 1.\n10. The expected survival period is ≥ 12 weeks.\n11. Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 7 days before the first study drug treatment):\n\n    1. Blood routine: absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet ≥100×109\u002FL and hemoglobin ≥90 g\u002FL;\n    2. Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the normal reference range (×ULN); when there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; ALT and AST ≤5 × ULN in liver metastasis;\n    3. Renal function: subjects with serum creatinine ≤ 1.5 × ULN or creatinine level\\> 1.5 times ULN, measured or calculated according to Cockcroft-Gault formula creatinine clearance rate ≥ 60.0 mL \u002F min;\n    4. Coagulation function: International normalized ratio (INR) ≤ 1.5 and partially activated prothrombin time (aPTT) ≤ 1.5 × ULN; (For patients undergoing anticoagulation therapy, the investigator judges that both INR and aPTT are safe and effective treatments Within);\n    5. Heart function: left ventricular ejection fraction (LVEF) detected by echocardiography\\>50%\n12. Women with fertility must have a negative serum pregnancy test within 7 days before the first medication. Reproductive male or female patients voluntarily use effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., from signing the informed consent until 90 days after the last study medication. All female patients will be considered fertile unless the female patient has been naturally menopausal, has undergone artificial menopause, or has been sterilized (such as hysterectomy, bilateral adnexectomy).\n\nExclusion Criteria:\n\n1. Participate in the clinical trials of other investigational drugs or investigational devices within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy (allowed to complete the palliative at least 1 week before the study drug treatment Radiotherapy) or targeted therapy.\n2. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level (hair loss, peripheral neurotoxicity caused by chemotherapy ≤ 2 can be selected). Subjects who need to use corticosteroids (\\> 10 mg\u002Fday prednisone equivalent dose) or other immunosuppressive drugs for systemic therapy within 14 days before the study drug is administered.\n\n   Note: If there is no active autoimmune disease, inhaled or topical steroid hormones, or adrenal hormone replacement therapy with a prednisone equivalent dose of ≤ 10 mg per day is allowed. Allow short-term (≤ 7 days) use of glucocorticoids for preventive treatment (for example, for subjects with a history of severe allergies, when other anti-allergic drugs cannot be used instead to prevent allergy to contrast agents, researchers can use glucocorticoids according to local diagnosis and treatment routines Prevention) or for the treatment of non-autoimmune diseases (for example, delayed type hypersensitivity caused by contact allergens).\n3. Subjects who have active, or have had autoimmune diseases or risks that may recur (for example, an organ transplant that requires immunosuppressive therapy). However, subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases that do not require systemic treatment (for example, vitiligo, psoriasis, or hair loss) are allowed to be included in the group. For any uncertain situation, it is recommended to consult the sponsor's medical monitor before signing the informed consent.\n4. Major surgery (except for biopsy) or the surgical incision did not heal completely within 4 weeks before the first study drug treatment.\n5. Suffered from other known malignant tumors within 2 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and\u002For carcinoma in situ after radical resection).\n6. Untreated brain metastases and Symptomatic brain metastasis or spinal cord compression after treatment ; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.\n7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, symptomatic interstitial lung disease or any evidence of active pneumonia detected by chest CT scan within 4 weeks prior to first study drug therapy.\n8. Subjects with a history of active tuberculosis infection within 1 year before the first study administration and a history of active tuberculosis infection more than 1 year ago were considered suitable for inclusion if the investigator determined that there was no evidence of active tuberculosis at present.\n9. Mental or substance abuse disorders that are known to interfere with test compliance.\n10. A history of human immunodeficiency virus (HIV) infection or an active bacterial or fungal infection requiring systematic treatment in the 14 days prior to initial study drug therapy.\n11. Uncontrolled hepatitis virus infection (positive for HBV DNA or HCV RNA) .\n12. Within 4 weeks of initial administration, there is ascites requiring drainage or diuretic treatment, or pleural or pericardial effusion requiring drainage and\u002For symptoms of tachypnea.\n13. Cardiovascular disease with significant clinical significance.\n14. Receive live or attenuated live vaccine within 4 weeks prior to the first study drug treatment.\n15. History of severe allergic reaction to humanized antibodies or fusion proteins.\n16. Any other disease , and the investigator had reason to suspect that the patient was not eligible for study drug therapy.\n17. Part II: The results of tumor tissue samples were MSI-H",{"count":96,"type":20},[53],"An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB uesd comfirmed TMB-H Value",[119],"Solid Tumor",[121],"TMB, solid tumor",{"date":32,"type":33},{"date":124,"type":33},"2021-08-06",{"date":126,"type":20},"2028-04-30",{"name":39,"class":40},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":41},"100336956","phase-2-kn035-for-dmmrmsi-h-advanced-solid-tumors-100336956","NCT03667170","KN035 for dMMR\u002FMSI-H Advanced Solid Tumors","Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.\n* Confirmed MMR deficient or MSI-H status.\n* At least one measureable lesion.\n* Eastern Cooperative Oncology Group performance status of 0 or 1 .\n* Life expectancy of greater than 12 weeks.\n* Adequate hematologic and organ function.\n\nExclusion Criteria:\n\n* Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study.\n* Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.\n* Has received prior therapy with an immune check point agonist\u002Finhibitor.\n* Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.\n* Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.\n* Known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Active autoimmune disease that has required systemic treatment.\n* Patients who have known history of infection with HIV.\n* Patients with evidence of interstitial lung disease.\n* Patients who have known history of any major cardiac abnormalities.\n* Patient who is not willing to apply highly effective contraception during the study.\n* Patients who have other concurrent severe and\u002For uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study.",{"count":136,"type":20},200,[53],"In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.\n\nFor colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.",[119],[141,142,143,144],"MSI-H","dMMR","Colorectal cancer","Non-Colorectal Cancers",{"date":32,"type":33},{"date":147,"type":33},"2018-08-22",{"date":149,"type":20},"2026-12-30",{"name":39,"class":40},""]