[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Taizhou Mabtech Pharmaceutical Co.,Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100640025","phase-3-comparing-efficacy-and-safety-of-enlituo-versus-erbitux-plus-folfox-in-locally-advancedmetastatic-colorectal-cancer-with-rasbraf-wild-type-and-msspmmr-status-100640025",false,"NCT07595276","Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced\u002FMetastatic Colorectal Cancer With RAS\u002FBRAF Wild-type and MSS\u002FpMMR Status.","A Multicenter, Randomized, Double-blind, Phase III Clinical Study Evaluating the Efficacy and Safety of Enlituo® Plus FOLFOX Versus Erbitux® Plus FOLFOX as First-line Treatment for Locally Advanced\u002FMetastatic Colorectal Cancer With RAS\u002FBRAF Wild-type and MSS\u002FpMMR Status.","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Aged 18 years or older.\n* Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic colorectal cancer.\n* Have at least one evaluable or measurable tumor target lesion (RECIST v1.1). Lesions that have received previous local therapy or locoregional therapy (e.g., radiotherapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous intervention) should not be considered measurable lesions unless progression is observed after the local or locoregional therapy.\n* Have not received prior systemic anti-tumor therapy for locally advanced\u002Fmetastatic colorectal cancer. Previous neoadjuvant or adjuvant therapy for colorectal cancer is allowed if completed ≥6 months before the detection of disease recurrence or metastasis.\n* Have an ECOG performance status of 0 or 1.\n* Have a life expectancy of ≥12 weeks.\n* Have locally advanced\u002Fmetastatic colorectal cancer confirmed by a local laboratory to be RAS\u002FBRAF wild-type and MSS\u002FpMMR.\n\nNote: RAS wild-type refers to wild-type status for KRAS exons 2, 3, 4 and NRAS exons 2, 3, 4.\n\n-Have adequate organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 2 weeks prior to the first dose of study treatment).\n\nHematology:\n\nAbsolute Neutrophil Count (ANC) ≥1.5 × 10⁹\u002FL Platelets ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL\n\nLiver Function :\n\nALT and AST in participants without liver metastases ≤2.5 × Upper Limit of Normal (ULN) Serum Total Bilirubin in participants without liver metastases ≤1.5 × ULN ALT and AST in participants with liver metastases ≤5 × ULN Serum Total Bilirubin in participants with liver metastases or Gilbert's syndrome ≤3 × ULN\n\nRenal Function :\n\nCreatinine Clearance calculated by Cockcroft-Gault formula ≥50.0 mL\u002Fmin Coagulation International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (aPTT) INR ≤1.5 or aPTT ≤1.5 × ULN (For participants receiving anticoagulant therapy, the investigator must judge the INR and\u002For aPTT to be within a safe and effective therapeutic range.)\n\nCardiac Function:\n\nLeft Ventricular Ejection Fraction (LVEF) measured by echocardiography or Multiple Gated Acquisition (MUGA) scan \\>50%\n\n* Women of childbearing potential (WOCBP) must agree to use reliable contraceptive methods to avoid the risk of pregnancy throughout the study treatment period and for 180 days after the last dose of study treatment.\n* WOCBP must have a negative serum pregnancy test result within 72 hours before the first dose of the investigational product.\n* Female participants must not be breastfeeding.\n* Male participants must agree to use reliable contraceptive methods from the first dose of study treatment until 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 3 years, except for locally curable tumors deemed by the investigator to have a low risk of recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)\n* Has not recovered from adverse events (AEs) due to prior anti-tumor therapy (i.e., not recovered to ≤ Grade 1 or to baseline, with the exception of alopecia, hypothyroidism controllable with hormone replacement therapy, and well-controlled type 1 diabetes on insulin therapy).\n* Prior treatment with EGFR-targeted antibodies (e.g., cetuximab, panitumumab, etc.), antibody-drug conjugates (ADCs) (e.g., MRG003, SHR-A1307, RC-68, etc.), or signal transduction inhibitors (e.g., gefitinib, osimertinib, etc.).\n* Currently participating in and receiving investigational drug therapy from another clinical trial, or has received investigational drug therapy or used an investigational device within 4 weeks prior to the first dose of study treatment (Note: this does not include the follow-up period of a study).\n* Major surgery within 4 weeks prior to the first dose of study treatment, or open biopsy within 1 week prior. (Minor procedures such as mediastinoscopy, placement of a central venous access device, placement of a gastric tube, needle biopsy, and percutaneous nephrostomy are not considered major surgery).\n* Any chemotherapy, immunotherapy, experimental therapy, or other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter, but at least 14 days) prior to the first dose of study treatment. Treatment with anti-tumor traditional Chinese medicine preparations or any radiotherapy within 2 weeks prior to the first dose of study treatment.\n* Known central nervous system metastases and\u002For carcinomatous meningitis. Ascites, pleural effusion, or pericardial effusion requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.\n* Known active infection requiring systemic therapy administered intravenously within 2 weeks prior to the first dose of study treatment.\n* History of active tuberculosis infection within 1 year. (Participants with a history of active tuberculosis may be eligible if the investigator judges there is no evidence of active tuberculosis for more than 1 year prior to the first dose of study treatment).\n* History of non-infectious pneumonitis requiring oral or intravenous steroids to aid recovery, or history of pulmonary fibrosis, interstitial lung disease, radiation pneumonitis, drug-related pneumonitis, or other severe lung function impairment such as severe chronic obstructive pulmonary disease.\n* Acute or subacute intestinal obstruction, or inflammatory bowel disease. Concomitant Diseases\u002FOther Exclusion Criteria\n* Known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Participants with active or chronic hepatitis B (HBsAg positive and HBV DNA ≥2000 IU\u002FmL or ≥10,000 copies\u002FmL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection. (Participants who are HBsAg positive or HBV-DNA positive at screening are recommended to receive antiviral therapy during the study according to clinical practice).\n* Clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe\u002Funstable angina, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or congestive heart failure (New York Heart Association class \\> II); symptomatic coronary artery disease requiring medication; arrhythmia requiring medication; QTcF interval \\> 480 ms on electrocardiogram; or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg despite adequate medication).\n* Significant clinically significant bleeding symptoms or a definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis, within 6 months prior to the first dose of study treatment.\n* Known hypersensitivity or allergic reaction to any component of the study treatment.\n* History of allogeneic tissue\u002Fsolid organ transplantation or graft-versus-host disease.\n* Treatment with any live vaccine within 4 weeks prior to the first dose of study treatment (with the exception of live-attenuated vaccines).\n* Known psychiatric or substance abuse disorder that would interfere with compliance with study requirements.\n* Any underlying medical condition that, in the investigator's judgment, would make the administration of the study drug hazardous to the participant or would obscure the interpretation of toxicity or adverse events.\n* Any other condition for which the investigator deems the participant unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},608,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS\u002FBRAF wild-type and MSS\u002FpMMR locally advanced\u002Fmetastatic colorectal cancer.\n\nEnrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX).\n\nParticipants will:\n\n* Receive Enlituo®\u002FErbitux®: 500 mg\u002Fm², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.\n* Receive FOLFOX\n* Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX.\n* Be recommended to undergo efficacy assessments every 8 weeks (±7 days).\n* Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses.\n* Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years.\n\nThe Blinded Independent Central Review (BIRC) will assess:\n\n* Objective Response Rate (ORR) within 16 weeks.\n* Disease Control Rate (DCR) within 16 weeks.\n* Duration of Response (DoR).\n* Progression-Free Survival (PFS).\n\nThe investigators will assess:\n\n* ORR within 16 weeks.\n* DCR within 16 weeks.\n* DoR.\n* PFS.\n* Overall Survival (OS).\n* Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations.\n* Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.",[26],"Colorectal Cancer","NOT_YET_RECRUITING","2026-05-12",{"date":30,"type":31},"2026-05-19","ACTUAL",{"date":33,"type":20},"2026-06-01",{"date":35,"type":20},"2030-06-01",{"name":37,"class":38},"Taizhou Mabtech Pharmaceutical Co.,Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100587798","phase-1-safety-and-tolerability-of-cmab017-in-patients-with-advanced-solid-tumors-100587798","NCT06933069","Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors","A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. fully understand and agree to sign the Informed Consent Form (ICF);\n2. histologically or cytologically confirmed, inoperable, locally advanced, recurrent or metastatic malignant solid tumors, including but not limited to head and neck squamous carcinoma, RAS wild-type colorectal cancer, esophageal squamous carcinoma, etc., for which the patient has failed standard treatment, does not have standard treatment, or refuses standard treatment;\n3. age 18\\~75 years old, gender is not limited;\n4. Eastern Cooperative Oncology Group (ECOG) score ≤1;\n5. expected survival ≥ 3 months;\n6. presence of at least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (bone-only metastases or central nervous system-only metastases will not be accepted as evaluable lesions); starting from 6 mg\u002Fkg Q3W, 4 mg\u002Fkg Q2W after the start of the dose group, presence of at least one measurable lesion; and dose groups, at least one measurable lesion is present (bone-only metastases or CNS-only metastases will not be accepted as measurable lesions);\n7. females of childbearing potential must be non-lactating and have a negative serum pregnancy test within 1 week prior to the first infusion and agree to use effective contraception from the time of signing the ICF until 6 months after the last infusion; male subjects must agree to use effective contraception from the time of signing the ICF until 6 months after the last infusion;\n8. Blood routine and liver and kidney functions during the screening period meet the following conditions:\n\n   * Blood routine: neutrophils ≥1.5×109\u002FL; platelets ≥75×109\u002FL; hemoglobin ≥90 g\u002FL;\n\n     * Liver function: alanine aminotransferase and aspartate aminotransferase ≤3×ULN (both should be ≤5×ULN for those with tumor liver metastasis); total bilirubin ≤1.5×ULN; ③ Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN; international normalized ratio (INR) ≤1.5×ULN (for patients not receiving anticoagulation therapy; APTT or INR of subjects receiving anticoagulation therapy should be within the expected therapeutic range of anticoagulant drugs); ④ Renal function: blood creatinine ≤ 1.5 x ULN; if creatinine \\> 1.5 x ULN, creatinine clearance (Ccr) \\> 50mL\u002Fmin is required (calculated according to the Cockcroft-Gault formula).\n\nExclusion Criteria:\n\n1. With known active CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may be enrolled in the study provided that they have been clinically stable for at least 2 weeks, have no evidence of new or expanding brain metastases, and have discontinued steroids within 2 weeks prior to the infusion of the trial drug. Stability of brain metastases should be determined prior to the first dose of the trial drug infusion. Patients with asymptomatic brain metastases (i.e., no neurologic symptoms, no need for medication, and no lesion with a longest diameter \\>1.5 cm) may be enrolled, but will be required to undergo periodic imaging;\n2. subjects with grade ≥2 corneal abnormalities present at screening;\n3. adverse effects of prior antineoplastic therapy that have not recovered to a CTCAE 5.0 grade rating of ≤ grade 1 or to the level specified in the entry criteria (except for toxicities judged by the investigator to be of no safety risk, e.g., alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy)\n4. other malignancies within the previous 5 years, usually with the exception of the following: a. any other aggressive malignancy (for which the subject has had adequate treatment) for which disease-free status has persisted for \\>3 years and which, in the investigator's assessment, would not interfere with the assessment of oncologic efficacy; and b. cured basal cell or squamous cell skin cancers, superficial bladder cancers, and locally curable cancers such as prostate, cervical, or breast cancer in situ;\n5. a history of immunodeficiency, including a positive HIV antibody test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation\n6. interstitial lung disease that is symptomatic or may interfere with pulmonary toxicity monitoring associated with the test drug;\n7. a history of serious cardiovascular or cerebrovascular disease, including, but not limited to: severe cardiac rhythm or conduction block, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, etc.; QTc intervals \\> 480 ms on 12\u002F15 lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke within 6 months prior to the first infusion or other grade 3 or higher cardiovascular events; NYHA cardiac function classification ≥ grade II or LVEF \\\u003C50%; clinically uncontrollable hypertension;\n8. any of the following within 4 weeks prior to the first trial drug infusion:\n\n   * Has had major surgery (defined as surgery requiring general anesthesia).\n   * has participated in a clinical trial and received investigational treatment or used an investigational device.\n   * Undergoing or planning other antineoplastic therapy outside of this study protocol (certain specific antineoplastic agents may be excluded from the 4 weeks prior to drug infusion, e.g., oral fluorouracil ≥ 2 weeks; mitomycin C, nitrosoureas ≥ 6 weeks; and small molecule targeted therapy ≥ 2 weeks);\n9. any of the following within 2 weeks prior to the first trial drug infusion:\n\n   * Having had localized palliative radiotherapy.\n   * Received herbal\u002Fproprietary Chinese medicines that are clearly indicated for the treatment of oncological indications.\n   * Has had minor surgery (other than major surgery, but diagnostic procedures such as incision and\u002For needle core biopsy are not considered minor surgery).\n   * Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor therapy;\n10. known intolerance to anti-EGFR monoclonal antibodies resulting in discontinuation due to rash, gastrointestinal toxicity, or other Grade 3 or 4 toxicity;\n11. Hepatitis B or C virologic testing at screening meets any of the following:\n\n    * HBsAg positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer test ≥1000 copies\u002FmL or ≥200 IU\u002FmL;\n    * Positive antibody to HCV;\n12. known severe allergic reaction to any component of the test drug or multiple drugs;\n13. third interstitial fluid that, in the opinion of the investigator, is clinically uncontrollable;\n14. any other serious or uncontrollable medical condition, active infection currently requiring intravenous anti-infective therapy, abnormal physical examination, abnormal laboratory tests, abnormal mental status, or psychiatric illness that, in the opinion of the Investigator, results in increased risk to the subject or otherwise affects the evaluation of study results.","75 Years",{"count":49,"type":20},55,[51],"PHASE1","This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.",[54],"Solid Malignancies","RECRUITING","2025-09-09",{"date":58,"type":31},"2025-09-11",{"date":60,"type":31},"2025-06-09",{"date":62,"type":20},"2026-05-31",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":39},"100508911","phase-4-post-marketing-registry-study-of-infliximab-for-injection-in-chinese-pediatric-crohns-disease-patients-100508911","NCT05906576","Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients","Inclusion Criteria:\n\n1. Age ranged 6 to 17 years (both inclusive), no gender limitation.\n2. A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).\n3. Patients and\u002For their guardians must sign ICF, and the research agreement\u002FICF for data collection and data verification shall comply with local laws and regulations.\n4. The patient received infliximab for the first time.\n\nExclusion Criteria:\n\n1. Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.\n2. Those who accept other anti-TNF-α any biological drugs or any other biologicals.\n3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period\n4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF\n5. The investigator judges the subject inappropriate to be included in this study.","6 Years","17 Years",{"count":73,"type":20},30,[75],"PHASE4","Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.",[78],"Crohn Disease","2025-05-19",{"date":81,"type":31},"2025-05-22",{"date":83,"type":31},"2023-09-21",{"date":85,"type":20},"2027-02",{"name":37,"class":38},""]