[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":549},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,43,65,87,109,131,153,174,196,218,239,259,280,301,323,344,363,384,405,426,448,468,488,509,528],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100641880","phase-1-a-clinical-study-of-tqb2930-injection-and-chemotherapy-with-or-without-bevacizumab-in-the-treatment-of-advanced-colorectal-cancer-100641880",false,"NCT07653685","A Clinical Study of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in the Treatment of Advanced Colorectal Cancer","A Phase Ib\u002FII Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance\n* Age: 18-75 years (including the boundary when signing the informed consent form)\n* Eastern Cooperative Oncology Group (ECOG) score: 0-1\n* Expected survival of more than 3 months\n* Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology\u002Fcytology\n* HER2 positive tested\n* Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Subjects should agree to use contraception during the study and for 6 months after the end\n\nExclusion Criteria:\n\n* Patients with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H\u002FdMMR)\n* Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications\n* Active inflammatory bowel disease within 28 days prior to first dose\n* Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies\n* Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy\n* Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment\n* Had wounds or fractures that had not been healed for a long time\n* Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose\n* Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders\n* Subjects with any severe and\u002For uncontrolled disease\n* Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks\n* Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study\n* Failure to control serous effusions requiring repeated drainage\n* Local radiotherapy or 4. Bone marrow irradiation \\> 30% for bone metastasis before the first medication\n* Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain\n* Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;\n* Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment\n* History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;\n* Previous history of severe allergy of unknown origin\n* According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or the subject is considered unsuitable for other reasons","ALL","18 Years","75 Years",{"count":21,"type":22},71,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in subjects with HER2-positive unresectable locally advanced or metastatic colorectal cancer (CRC).",[29],"Colorectal Cancer","NOT_YET_RECRUITING","2026-06-12",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":22},"2026-07",{"date":38,"type":22},"2028-12",{"name":40,"class":41},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","INDUSTRY",24,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":64},"100632353","phase-1-clinical-studies-of-tqb2930-injection-for-the-treatment-of-advanced-solid-tumors-100632353","NCT07512583","Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors","Phase Ib\u002FII Clinical Trial of TQB2930 Injection in Combination With TQB2102 for Injection in Patients With HER2-Expressing Advanced Solid Tumors","Inclusion Criteria:\n\n* The subjects voluntarily joined this study, signed an informed consent form, and had good compliance;\n* Age between 18 and 75 years old (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) score from 0 to 1;\n* Expected survival is greater than 12 weeks;\n* Advanced solid tumors with HER2 expression confirmed by histopathological\u002Fcytological examination. HER2 expression includes HER2 positive (including Immunohistochemistry (IHC) 3+, IHC 2+and Fish positive), HER2 low expression (including IHC 1+ IHC 2+and Fish negative, HC 0 but with HER2 expression);\n* Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;\n* The laboratory inspection meets the following standards:\n\n  * Blood routine: Hemoglobin (HGB) levels in the past 14 days without the use of growth factors or blood transfusions\n\n    * 90g\u002FL ； Neutrophil absolute value (NEUT) ≥ 1.5 × 10 9\u002FL; Platelet count (PLT)\n    * 100×10 9 \u002FL ；\n  * Liver function: For patients without liver metastasis, total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal (ULN), For patients with liver metastasis, total bilirubin (TBIL) ≤ 3.0 times the upper limit of normal (ULN); Alanine group Transferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If accompanied by liver transformation Move, then ALT and AST ≤ 5 × ULN;\n  * Renal function: Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml\u002Fmin (Using the standard Cockcroft Gault formula);\n  * Urine routine test shows a urine protein concentration of ≤ 1+; If urinary protein is ≥ 2+, it needs to be tested for 24 hours within 7 days Urine protein quantitative testing can only be selected when the 24-hour urine protein is less than 1g;\n  * Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT) International Normalized Ratio (INR) ≤ 1.5 × ULN;\n  * Cardiac function: Left ventricular ejection fraction ≥ 50%;\n* Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study Shi had a negative serum pregnancy test within 7 days prior to enrollment in the study; Men should agree during and after the study period Effective avoidance measures must be taken within 6 months after completion.\n\nExclusion Criteria:\n\n* Patients with known spinal cord compression or active central nervous system metastasis (defined as untreated or symptomatic metastasis, or requiring corticosteroids or anticonvulsants to control related symptoms) are excluded, unless they have been stable for at least 4 weeks after treatment (no new or expanding imaging evidence of brain metastasis) and have not used corticosteroids and anticonvulsants within 2 weeks before randomization.\n* Subjects with only cutaneous and\u002For intracranial lesions as target lesions.\n* Concurrent diseases and medical history:\n\n  * Have had or currently have other malignant tumors within 5 years, except for the following conditions: cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)\\], differentiated thyroid cancer, and colorectal intra-mucosal cancer;\n  * The adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events Version (CTCAEv5.0) score of ≤1, except for Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which the investigator deems to pose\n  * Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (excluding surgeries specified in the protocol) within 4 weeks before the first dose, or have long-term unhealed wounds or fractures (excluding pathological fractures, but if there is severe bone damage in bone metastases and it may affect survival, it needs to be excluded). (Major surgery is defined as surgeries at or above level 3 in the National Surgical Classification Catalogue 2022 edition);\n  * There are diseases that affect intravenous injection and venous blood sampling;\n  * Subjects with congenital bleeding or coagulation dysfunction, or those who have experienced bleeding or coagulopathy within 28 days prior to the commencement of study treatment, or who have taken aspirin \\>325 mg\u002Fday (the maximum antiplatelet dose) within 7 days prior to the commencement of study treatment;\n  * Cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, except for asymptomatic and non-treatment-required lacunar cerebral infarction) or pulmonary embolism occurred within 6 months before the first dose; currently, there is deep venous thrombosis requiring therapeutic intervention;\n  * Poor blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);\n  * Suffering from major cardiovascular diseases, including any of the following conditions:\n\n    * Cardiac insufficiency at or above New York Heart Association (NYHA) class II;\n\n      * History of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, and torsade de pointes) or frequent and uncontrollable arrhythmias;\n\n        * Unstable angina pectoris, or severe stenosis and occlusion of the coronary artery;\n\n          * Suffered from myocardial infarction within 6 months;\n\n            * The Fridericia-corrected QT interval (QTcF) is greater than 450 milliseconds (msec) for males and greater than 470 msec for females (if QTc is abnormal, it can be continuously measured three times with an interval of more than 2 minutes, and the average value can be taken);\n\n              * History or family history of congenital long QT syndrome;\n  * Presence of uncontrolled infection of ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 14 days prior to the commencement of study treatment;\n  * Subjects with a history of interstitial lung disease\u002Fpneumonia (non-infectious) requiring steroid intervention, or currently accompanied by interstitial lung disease\u002Fpneumonia, or subjects with suspected interstitial lung disease\u002Fpneumonia indicated by imaging during the screening period and unable to be excluded;\n  * Subjects with moderate to severe pulmonary dysfunction\u002Fdisease within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobstructive bronchiolitis, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, etc.; subjects with active tuberculosis, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia during the screening period; and subjects with any autoimmune, connective tissue, or inflammatory diseases involving the lungs (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or those who have previously undergone unilateral pneumonectomy, etc.;\n  * Subjects with active viral hepatitis and poor control. Subjects who meet the following requirements can be screened: HBsAg-positive subjects must meet the criteria of Hepatitis B Virus (HBV) DNA quantification \\\u003C2000 IU\u002Fml (or 1\\*104 copy\u002Fml) or have received anti-HBV treatment for at least 1 week before the start of the study and have a 10-fold (1 log value) or greater reduction in viral index, and the subjects are willing to receive anti-HBV treatment throughout the entire study period; HCV-infected subjects (HCV Ab or HCV RNA positive): subjects who are judged by the investigator to be in a stable state or are currently undergoing antiviral treatment at the time of enrollment and continue to receive approved antiviral treatment during the study;\n  * Individuals with active syphilis infection requiring treatment;\n  * Those who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;\n  * Subjects who require immunosuppressive agents, systemic or absorbable local hormone therapy for immunosuppression, and still need to continue using them within 7 days before the first administration (excluding subjects with a daily dose of \\\u003C10 mg prednisone or other equally effective hormones);\n  * History of immune deficiency, including HIV positivity or other acquired or congenital immune deficiency diseases;\n  * Patients with renal failure requiring hemodialysis or peritoneal dialysis; or those who have previously had or currently have nephrotic syndrome (excluding those who have been cured) or chronic nephritis;\n  * Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n  * Those who suffer from epilepsy and require treatment;\n  * Individuals with a history of abuse of psychotropic drugs and unable to quit, or those with severe mental disorders.\n* Tumor-related symptoms and treatment:\n\n  * There has been moderate to large amounts of pleural effusion, ascites, and pericardial effusion in the past 2 weeks;\n  * Patients with cancerous lymphangitis;\n  * Tumor invasion of major blood vessels;\n  * Patients who have received intravenous chemotherapy, radiotherapy, immunotherapy, biotherapy, or macromolecular targeted therapy for anti-tumor treatment within 3 weeks before the start of the study treatment, or who have received endocrine therapy, small molecule targeted drugs, or oral chemotherapy within 2 weeks before the start of the study treatment, the washout period is calculated from the end of the last treatment;\n  * Patients who have received treatment with traditional Chinese patent medicines and simple preparations (including but not limited to Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Brucea javanica oil injection\u002Fcapsules, Xiaocaiping Tablets\u002FInjection, Huachansu Capsules, etc.) with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) -approved drug instructions within 2 weeks before the start of the study treatment.\n* Research treatment-related\n\n  * Previously received ADC therapy using a topoisomerase 1 inhibitor as the toxin during the recurrence or metastasis stage, or experienced recurrence or metastasis within 12 months after neoadjuvant\u002Fadjuvant therapy (excluding cohort 5 in the extension stage);\n  * Allergic to any research drug or any ingredient or adjuvant in the drug; 39. 3) Individuals who have experienced severe hypersensitivity reactions after the use of monoclonal antibodies;\n  * Subjects who have received treatment with other anti-tumor drugs in clinical trials within 4 weeks prior to the start of the study treatment, if the clinical study involves a marketed drug, shall be excluded according to exclusion criterion 4.2).\n* According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.",{"count":51,"type":22},178,[25,26],"This is a multicenter, open-label, multi-cohort phase Ib\u002FII clinical study to evaluate the efficacy and safety of TQB2930 in combination with TQB2102 in patients with HER2-expressing advanced solid tumors.",[55],"Advanced Solid Tumor","RECRUITING","2026-06-05",{"date":59,"type":34},"2026-06-08",{"date":61,"type":34},"2026-05-27",{"date":38,"type":22},{"name":40,"class":41},3,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":86},"100596584","phase-3-tqb2930-injection-for-the-treatment-of-her2-positive-advanced-breast-cancer-100596584","NCT07047365","TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer","A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign the informed consent form;\n* Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy \\>3 months;\n* Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;\n* Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;\n* At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);\n* Willing to receive one of the investigator-selected chemotherapy regimens;\n* Adequate organ function;\n* Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n* Concurrent Diseases and Medical History:\n\n  * Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);\n  * Uncontrolled toxicities (\\>CTCAE Grade 1) from prior therapies (excluding alopecia);\n  * Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;\n  * Non-healing wounds or fractures;\n  * Arterial\u002Fvenous thromboembolic events within 6 months before randomization;\n  * History of drug abuse or psychiatric disorders that may affect compliance;\n  * Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) \\>160 mmHg despite treatment);\n  * ≥Grade 2 myocardial ischemia\u002Finfarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);\n  * Active or uncontrolled severe infections (≥CTCAE Grade 2);\n  * Known chronic hepatitis B;\n  * Active syphilis infection;\n  * Renal failure requiring hemodialysis\u002Fperitoneal dialysis;\n  * Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;\n  * Poorly controlled diabetes;\n  * Urine protein ≥++ on dipstick with 24-hour urine protein \\>1.0 g;\n  * Epilepsy requiring medication.\n* Tumor-Related Conditions and Treatments:\n\n  * Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization (or within 5 half-lives of prior drugs, whichever is shorter);\n  * Chinese herbal medicines with approved antitumor indications (per National Medical Products Administration (NMPA) labeling) within 2 weeks;\n  * Severe Bone Lesions from bone metastases;\n  * Untreated brain metastases, Leptomeningeal metastases, or carcinomatous meningitis;\n  * Prior HER2-targeted therapy-induced Left Ventricular Ejection Fraction (LVEF) decline to \\\u003C50% or absolute reduction \\>15%;\n  * Uncontrolled or symptomatic Hypertension requiring ongoing bisphosphonates;\n  * Uncontrolled cancer-related pain;\n  * Existed Lymphangitis Carcinomatosa or uncontrolled effusions;\n  * Use of Immunosuppressant or systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent) within 2 weeks.\n* Severe hypersensitivity to monoclonal antibodies;\n* Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;\n* Any condition deemed by the investigator to jeopardize subject safety or study completion.",{"count":73,"type":22},416,[75],"PHASE3","TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.",[78],"HER2-positive Advanced Breast Cancer","2026-06-02",{"date":81,"type":34},"2026-06-03",{"date":83,"type":34},"2025-07-25",{"date":38,"type":22},{"name":40,"class":41},75,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100574100","phase-1-clinical-trial-of-tqh3906-capsules-for-the-treatment-of-adult-patients-with-moderately-to-severely-active-ulcerative-colitis-or-crohns-disease-100574100","NCT06754891","Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 in Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Age between 18-75 years (inclusive of both 18 and 75), regardless of gender.\n* Diagnosed with ulcerative colitis or Crohn's disease for ≥3 months, as assessed by histological or endoscopic examination prior to screening.\n* Active moderate to severe UC or CD.\n* Subjects must have failed at least one of the following drug treatments for UC or CD or be intolerant: oral aminosalicylates, oral corticosteroids, immunosuppressants, biologics, etc.\n* If subjects are using the following drugs for UC or CD at the time of screening, their treatment should be stabilized with oral aminosalicylates for at least 3 weeks before the first dose of the trial medication, or stabilized with oral systemic corticosteroids for at least 2 weeks before the first dose of the trial medication, and maintain a stable dose during the trial period.\n* If oral aminosalicylate or combined hormone therapy has been discontinued recently, it must be discontinued for at least 2 weeks prior to the pre-randomization endoscopy.\n* Subjects (including partners) are willing to voluntarily take appropriate and effective contraceptive measures from the time of screening until 3 months after the last administration of the study medication.\n* Before the trial, understand in detail the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, understand the research procedures, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Lesions confined solely to the rectal segment within 15 cm of the anus.\n* Subjects diagnosed with indeterminate colitis, radiation colitis, or ischemic colitis.\n* Presence of severe complications such as local stricture, intestinal obstruction, intestinal perforation, major lower gastrointestinal hemorrhage, intestinal neoplastic changes or neoplastic potential, toxic megacolon; rectal\u002Fcolonic polyps, or anal diseases that the investigator assesses may impact efficacy and safety evaluation.\n* Subjects with current stomas, ileostomy-anal anastomoses, or fistulas, where the physician determines surgery or medical intervention may be required within 12 weeks of study entry, or where ileostomy or colostomy may be necessary.\n* Subjects with extensive small bowel resection (\\>100 cm) or diagnosed short bowel syndrome, or requiring total parenteral nutrition.\n* Subjects with documented positive Clostridium difficile toxin (C. difficile) testing or polymerase chain reaction (PCR) testing.Polymerase Chain Reaction (PCR) test. If positive, the subject may be rescreened after appropriate treatment and retested no earlier than 7 days after treatment completion.\n* Patients with confirmed cytomegalovirus-associated colitis must have undergone adequate treatment for at least 3 months prior to the screening endoscopy and must be symptom-free.\n* Presence of abnormal seroviral status during the screening period:\n\na Active hepatitis, or hepatitis B surface antigen (HBsAg) positive with Hepatitis B Virus (HBV) DNA positive, or hepatitis B core antibody (HBcAb) positive with HBV-DNA positive, or Hepatitis C Virus (HCV) antibody positive with HCV-RNA positive; b Screening-period HIV antibody positive, or prior history of HIV infection; c. Positive treponemal antibody during screening without positive treponemal serological test (RPR or TRUST).\n\n* History of active tuberculosis during screening or prior to enrollment, or detection of latent tuberculosis infection during screening (defined as T-cell Spot of Tuberculosis (T-SPOT.0) positive without clinical manifestations). (Note: Patients with latent tuberculosis infection may initiate preventive treatment according to guidelines for 1 month. To continue in the study, patients must agree to complete the prophylactic treatment regimen during the study period, avoiding rifampin therapy.\n* History of severe herpes zoster or herpes simplex infections, including but not limited to herpes encephalitis, disseminated herpes simplex, or generalized herpes zoster.\n* History of severe bacterial, fungal, or viral infection requiring hospitalization with intravenous antibiotics or antiviral therapy within 2 months prior to first dosing.\n* Receipt of live vaccine within 4 weeks prior to first dosing or planned administration of live vaccine during the study period.\n* Development of clinically significant infection during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, or herpes zoster requiring antibiotic or antiviral treatment.\n* Presence of any major disease or unstable clinical condition (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immunologic, or locally active infection\u002Finfectious disease) deemed by the investigator to make participation in this study inappropriate.\n* Suffering from angina pectoris, arrhythmia, or congestive heart failure requiring medication, or exhibiting clinically significant abnormalities on screening ECG.\n* Abnormal screening laboratory tests:\n\n  i. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN); a Hemoglobin \\\u003C 90 g\u002FL; b White blood cell count \\\u003C 3.0 × 10⁹\u002FL; c Neutrophil count \\\u003C 1.0 × 10⁹\u002FL; d Lymphocyte count \\\u003C 0.5 × 10⁹\u002FL; e Platelet count \\\u003C 100 × 10⁹\u002FL; f Total bilirubin \\> 2 times ULN; g Other significant laboratory abnormalities deemed by the investigator to make the subject unsuitable for this study.\n* Subjects with poorly controlled diabetes or diabetes with major complications (e.g., retinopathy or nephropathy).\n* History of malignancy (including carcinoma in situ) or lymphoproliferative disorders within 5 years prior to first dosing.\n* Within 8 weeks or 5 half-lives (whichever is longer) prior to the first dose, patients must have received ≤2 classes of biologics (e.g., anti-Tumor Necrosis Factor-alpha (TNF-α) agents are considered 1 class), including but not limited to anti-TNF-α and anti-α4β7 integrin agents.\n* Patients who have received Janus Kinase (JAK) inhibitors or other small molecule inhibitors (excluding those targeting Tyrosine Kinase 2 (TYK2) or TYK2\u002FJAK1) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose may be enrolled if the washout period is satisfied.\n* Previously received treatment with small-molecule drugs targeting the same TYK2 or TYK2\u002FJAK1 target.\n* Received fecal microbiota transplantation, cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, immunosuppressants, or similar medications within 4 weeks prior to first dose.\n* Received any other investigational drug within 1 month or 5 half-lives (whichever is longer) prior to the first dose.\n* Underwent surgery within 4 weeks prior to the first dose, or plans to undergo surgery during the study period.\n* Received immunoglobulin or blood products within 4 weeks prior to the first dose.\n* Use of potent CYP450 inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) within 4 weeks prior to first dose.\n* Use of topical therapy (enemas or suppositories), intravenous corticosteroids, anti-UC or CD traditional Chinese medicine, anti-infective agents, or antidiarrheal medications.\n* Received nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to first dose (excluding topical NSAIDs and low-dose aspirin for cardiovascular protection).\n* Organ transplant recipients requiring ongoing immunosuppressive therapy.\n* Known allergy to any component of TQH3906 or history of severe drug hypersensitivity.\n* History of substance abuse or positive urine drug screen.\n* Any other reasonable medical, psychiatric, or social reason deemed by the investigator to preclude participation in this study.",{"count":95,"type":22},135,[25],"This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort.\n\nweek treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy.\n\nDose Group Design:\n\nGroup A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.",[99],"Inflammatory Bowel Diseases","2026-05-07",{"date":102,"type":34},"2026-05-12",{"date":104,"type":34},"2025-01-28",{"date":106,"type":22},"2027-12",{"name":40,"class":41},30,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100549244","phase-1-a-study-of-tqb2102-for-injection-in-the-treatment-of-her2-positive-biliary-tract-cancer-100549244","NCT06431490","A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer","A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n* 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;\n* Subjects must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH) positive;\n* The main organs function well;\n* Meet the criteria for advanced biliary tract cancer:\n\n  1. Biliary tract carcinoma confirmed by histology or cytology;\n  2. Non-operable locally advanced, recurrent and\u002For metastatic disease with at least one measurable lesion according to Evaluation criteria for the efficacy of solid tumors (RECIST) 1.1 criteria;\n  3. Failure of 1-2 prior lines of systemic therapy\n* Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period;\n* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.\n\nExclusion Criteria:\n\n* Complicated diseases and medical history:\n\n  1. Have had or are currently suffering from other malignant tumors within 3 years before the first medication;\n  2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;\n  3. Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;\n  4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic\u002Fvenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period;\n  5. Active viral hepatitis with poor control;\n  6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;\n  7. Have a history of psychotropic drug abuse and can not quit or have mental disorders;\n  8. People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;\n  9. Have a history of hepatic encephalopathy;\n  10. Currently on or recently used (within 7 days before the start of study treatment) aspirin (\\>325 mg\u002F day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;\n  11. Subjects with any severe and\u002For uncontrolled disease.\n* Tumor related and treatment:\n\n  1. For subjects who have received chemotherapy, immunotherapy within 3 weeks before the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (as the shortest time of occurrence), the washout period is calculated from the end time of the last treatment;\n  2. Within 2 weeks before the first use of the drug, the treatment of Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;\n  3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding;\n  4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage;\n  5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage);\n  6. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks.\n* Research treatment related:\n\n  1. Known allergy to study drug excipients;\n  2. Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited);\n  3. Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids \\\u003C10 mg per day of prednisone or other therapeutic hormones).\n  4. Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.\n  5. According to the judgment of the researcher, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.",{"count":117,"type":22},102,[25,26],"To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.",[121],"Biliary Tract Cancer","2026-04-02",{"date":124,"type":34},"2026-04-08",{"date":126,"type":34},"2024-07-22",{"date":128,"type":22},"2029-12",{"name":40,"class":41},43,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100596305","phase-3-a-clinical-study-of-neoadjuvant-treatment-with-tqb2102-for-injection-for-human-epidermal-growth-factor-receptor-2-her2-positive-breast-cancer-100596305","NCT07043725","A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer","A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression","Inclusion Criteria:\n\n* Voluntarily participate in this study, sign the informed consent form, and have good compliance;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \\>6 months;\n* Histologically or cytologically confirmed HER2-positive invasive breast cancer;\n* Hormone receptor (HR) status confirmed;\n* Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;\n* Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;\n* Major organ function is adequate, meeting specific criteria;\n* Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion\n\nExclusion Criteria:\n\n* Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;\n* Bilateral breast cancer or inflammatory breast cancer;\n* History of invasive breast cancer or ductal carcinoma in situ;\n* Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;\n* Comorbidities and medical history:\n\n  * Other malignancies within 5 years or currently;\n  * Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;\n  * Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds\u002Ffractures;\n  * Conditions affecting intravenous injection or blood sampling;\n  * Congenital bleeding or coagulation disorders, or bleeding\u002Fcoagulation disorders within 28 days before study treatment, or use of aspirin \\>325 mg\u002Fday (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;\n  * Arterial\u002Fdeep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;\n  * Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);\n  * Significant cardiovascular disease, including；\n  * Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;\n  * History of interstitial lung disease\u002Fpneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease\u002Fpneumonitis, or suspected interstitial lung disease\u002Fpneumonitis on screening imaging that cannot be ruled out;\n* Tumor-related symptoms and treatment:\n\n  * Prior excisional biopsy of primary tumor and\u002For axillary lymph nodes or sentinel lymph node biopsy before study treatment;\n  * Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);\n  * Prior taxane or carboplatin therapy for any malignancy;\n  * Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.\n* Study treatment-related:\n\n  * Severe hypersensitivity to monoclonal antibodies;\n  * Uncontrolled active autoimmune disease within 2 weeks before study treatment;\n  * Allergy to any study drug or its components\u002Fexcipients;\n  * Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.\n* Any condition judged by the investigator to jeopardize subject safety or study completion.",{"count":139,"type":22},544,[75],"This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.",[143],"HER2-positive Breast Cancer","2026-03-26",{"date":146,"type":34},"2026-03-27",{"date":148,"type":34},"2025-09-15",{"date":150,"type":22},"2029-09",{"name":40,"class":41},78,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":173},"100630131","phase-3-a-clinical-study-to-evaluate-injection-tqb2102-for-the-treatment-of-patients-with-her2-ihc3-advanced-colorectal-cancer-who-progressed-after-treatment-with-oxaliplatin-irinotecan-and-fluoropyrimidine-based-drugs-100630131","NCT07483684","A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs","A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs","Inclusion Criteria:\n\n* The subject voluntarily participates in this study, signs the informed consent form, and has good compliance.\n* Aged 18 to 75 years old (calculated as of the date of signing the informed consent form).\n* Subjects with histologically or cytologically confirmed advanced colorectal cancer.\n* The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor.\n* The subject must provide a sufficient quantity of qualified tumor specimens (fresh or archived samples collected within the past 3 years from primary or metastatic lesions) for central laboratory testing of HER2 status.\n* Advanced colorectal cancer that has progressed on or been intolerant to at least 2 prior lines of standard therapy (defined as disease progression or intolerable toxicity during or within 3 months after the last standard therapy).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Expected survival of greater than 12 weeks.\n* Presence of at least one measurable lesion as confirmed by RECIST 1.1 criteria.\n* Laboratory tests must meet criteria\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study ends, and have a negative serum or urine pregnancy test within 7 days prior to study entry. Men must agree to use effective contraception during the study and for 6 months after the study ends.\n\nExclusion Criteria:\n\n* A history of other malignant tumors within 3 years prior to the first dose, or concurrent malignant tumors at screening. Subjects are eligible for enrollment if they meet one of the following two conditions:\n\n  * Other malignant tumors treated with curative intent via a single surgical procedure, with disease-free survival (DFS) maintained for 5 consecutive years;\n  * A history of cured carcinoma in situ of the cervix, non-melanoma skin cancer, or superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\].\n* Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.).\n* Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks.\n* Receipt of major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose; or planned major surgery during the study period (excluding surgeries specified in the protocol); or presence of unhealed wounds or fractures for a prolonged period.\n* Clinically significant tumor bleeding or perforation within 1 month prior to the first dose; or any bleeding event ≥ Grade 3 per CTCAE v5.0; or subjects with bleeding or coagulation disorders receiving warfarin, aspirin, or other antiplatelet agents (excluding maintenance doses: aspirin ≤ 100 mg\u002Fday, clopidogrel ≤ 75 mg\u002Fday); or subjects with a history or signs of bleeding deemed ineligible by the investigator.\n* A history of thrombotic or embolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) \\[excluding subjects with isolated calf vein thrombosis ≤ 7 mm in diameter, ≤ 5 cm in length, not involving ≥ 2 veins, and assessed by the investigator as having no risk of thrombus progression\\], and pulmonary embolism, etc.\n* Presence of major cardiovascular diseases.\n* A history of decompensated liver cirrhosis or hepatic encephalopathy.\n* Subjects with active chronic hepatitis B or active chronic hepatitis C. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening must undergo additional testing for Hepatitis B Virus (HBV) DNA titer or HCV RNA quantification.\n* Active syphilis infection requiring treatment.\n* A history of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring corticosteroid therapy; or current diagnosis of non-infectious pneumonitis\u002Finterstitial lung disease; or hospitalization for any active infection or receipt of therapeutic antibiotics within 4 weeks prior to the start of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n* Active or uncontrolled severe infection (≥ Grade 2 infection per CTCAE v5.0).\n* A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders.\n* A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Tumor-related symptoms and treatments.\n* Known hypersensitivity or allergic reaction to any study drug or its excipients.\n* Prior receipt of anti-HER2 antibody-drug conjugate (ADC) therapy.\n* Receipt of any anticancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational drug therapy within 4 weeks or 5 half-lives prior to the first dose of this study, whichever is shorter.\n* Pregnant or lactating subjects.\n* Vaccination with live-attenuated vaccines within 28 days prior to the start of study treatment, or inactivated vaccines within 7 days prior; or planned vaccination during the study period.\n* Any other condition judged by the investigator to pose a serious risk to subject safety or interfere with the subject's completion of the study.",{"count":161,"type":22},142,[75],"This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens.\n\nThe primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores.\n\nApproximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group or the control group.",[165],"HER2 IHC3+ Advanced Colorectal Cancer","2026-03-17",{"date":168,"type":34},"2026-03-19",{"date":170,"type":22},"2026-03",{"date":38,"type":22},{"name":40,"class":41},48,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":130},"100624161","phase-2-a-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-tqh3906-capsules-in-the-treatment-of-active-psoriatic-arthritis-100624161","NCT07406035","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis","A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis","Inclusion Criteria:\n\n* Sign a written Informed Consent Form, which must meet the following requirements\n\n  * Be willing to participate in the study and able to sign the informed consent form;\n  * Be willing and able to complete all study-specific procedures and visits;\n* PsA trial participant disease characteristics\n\n  * Aged 18 to 70 years（inclusive）;\n  * BMI ≥ 18 kg\u002Fm² at screening; diagnosed with PsA for at least 3 months prior to screening, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening;\n  * Active arthritis at screening and at baseline (Day 1);\n  * Has failed or was intolerant to at least one prior therapy;\n  * If receiving a conventional synthetic Disease-Modifying Antirheumatic Drug (csDMARD), trial participants must be on only one DMARD, which must have been administered for at least 3 months prior to screening, with a stable dose for at least 28 days prior to the first dose;\n  * If using NSAIDs, the dose must have been stable for at least 14 days before the first dose;\n  * If using oral corticosteroids, the dose must have been stable for at least 14 days before the first dose;\n  * Topical treatments for plaque psoriasis must have remained stable for at least 14 days before the first dose;\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study\n\nExclusion Criteria:\n\n* Presence of conditions other than PsA:\n\n  * Presence of non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) at screening or first dose;\n  * Presence of any other autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, etc.;\n  * Presence of active (i.e., currently symptomatic) fibromyalgia;\n* Other Medical Conditions and Medical History:\n\n  * Trial participants who are pregnant or breastfeeding;\n  * Evidence of a serious illness\u002Fcondition or unstable clinical condition, or localized active infection\u002Finfectious disease;\n  * Any major surgery performed within 30 days prior to the first dose of study treatment, or any planned surgery during the study;\n  * Cancer or a history of cancer or lymphoproliferative disease within the past 5 years;\n  * New York Heart Association (NYHA) Class III or IV congestive heart failure, or any recent episode of heart failure resulting in NYHA Class III\u002FIV symptoms; or a history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic drug therapy;\n  * Uncontrolled hypertension at screening or randomization;\n  * History of thrombotic disease within 24 weeks prior to screening; viii. History of acute coronary syndrome and\u002For any major cerebrovascular disease within 24 weeks prior to screening;\n  * Current or recent (within 3 months prior to randomization) gastrointestinal disease that may affect absorption of study treatment, including gastrointestinal surgery;\n  * Severe blood loss (\\> 500 mL) or blood transfusion within 4 weeks prior to randomization;\n  * Inability to take oral medication;\n  * Inability to undergo venipuncture and\u002For tolerate venous access;\n  * History of substance abuse with inability to abstain or presence of a psychiatric disorder;\n  * Any other medical, psychiatric, and\u002For social reason as determined by medical judgment;\n* Prior and concomitant medications: If the trial participant has a history of biologic use, the exclusion criteria specified in the protocol will apply;\n* Infection-related:\n\n  * Active tuberculosis identified by chest radiography within 6 months prior to screening; trial participants with a negative chest radiography within 3 months prior to screening are eligible if they meet the protocol requirements;\n  * Hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) infection; or syphilis infection requiring treatment;\n* Abnormal physical examination or laboratory findings;\n* Other:\n\n  * History of any major drug allergy; known allergy to any excipient of the investigational product;\n  * Inability to comply with the trial protocol;\n  * History of substance abuse with inability to abstain or presence of a psychiatric disorder;\n  * Participation in another clinical trial and use of another investigational drug (other than for psoriatic arthritis) within 4 weeks prior to the first dose, based on the date of discontinuation from the previous trial;\n  * Planned or previous allogeneic bone marrow transplantation or solid organ transplantation;\n  * Any condition that, in the investigator's judgment, poses a serious risk to the safety of the trial participant or affects the participant's ability to complete the study.","70 Years",{"count":183,"type":22},156,[26],"This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.",[187],"Psoriatic Arthritis","2026-02-05",{"date":190,"type":34},"2026-02-12",{"date":192,"type":22},"2026-04",{"date":194,"type":22},"2027-11",{"name":40,"class":41},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100596307","phase-1-a-clinical-trial-evaluating-injection-of-tqb6411-in-subjects-with-advanced-malignant-tumors-100596307","NCT07043751","A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors","A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;\n* 18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) score 0\\~1 point;\n* Expected survival is greater than 12 weeks;\n* According to the RECIST v1.1 standard, there is at least one evaluable tumor lesion in the dose escalation stage, and at least one measurable lesion in the dose expansion stage;\n* Laboratory examination standards that meet the program requirements (no use of hematopoietic stimulator drugs for correction within 7 days);\n* Subjects who failed or were intolerant of standard treatment;\n* Subject requirements for the dose expansion stage: advanced NSCLC; metastatic colon cancer; recurrent\u002Fmetastatic esophageal squamous cell carcinoma; recurrent\u002Fmetastatic nasopharyngeal carcinoma; advanced malignant solid tumor;\n* Can provide tumor tissue specimens that meet the requirements for immunohistochemical testing;\n* Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that the serum or urine pregnancy test will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;\n\nExclusion Criteria:\n\n* Have appeared or are currently suffering from other malignant tumors;\n* There are diseases that affect intravenous injection and intravenous blood collection;\n* The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;\n* Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;\n* Subjects with any bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* People with active viral hepatitis and poor control;\n* People infected with active syphilis who need treatment;\n* There is a history of active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia\u002Fradio-pneumonia that needs treatment, or active pneumonia with obvious clinical symptoms, and interstitial lung disease (ILD) that needs treatment, or currently associated with interstitial lung disease;\n* Those with a history of abuse of psychotropic substances and cannot quit or have mental disorders;\n* Preparing for or having previously received allogeneic bone marrow transplants or solid organ transplants;\n* Have a history of hepatic brain disease;\n* Suffering from major cardiovascular disease;\n* Severe infection that is active or uncontrollable (≥CTC AE grade 2 infection);\n* People who require hemodialysis or peritoneal dialysis if renal failure is required;\n* Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;\n* Subjects who have poorly controlled autoimmune diseases and need to use immunosuppressive agents or systemic hormones to achieve immunosuppressive purposes and still need to continue using them within 7 days before the first dose (except for daily dose of glucocorticoid \\\u003C10 mg prednisone or other therapeutic hormones);\n* People with epilepsy and need treatment;\n* Poor diabetes control \\[fasting blood sugar (FBG) \\> 10mmol\u002FL\\];\n* Tumor-related symptoms and treatment: subjects who have received chemotherapy, immunotherapy, small molecule targeted drugs, etc. within 3 weeks before the first dose, or are still in the 5 half-life of the drug; within 1 week before the first dose, they have received Chinese patent medicine treatment with anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions; imaging (CT or MRI) shows that the tumor has invaded important blood vessels or the researchers judged that the tumor is very likely to invade important blood vessels during the subsequent study and causing fatal major bleeding; if it is not controlled, pleural effusion, pericardial effusion or moderate and severe ascites that still require repeated drainage; known to suffer from spinal cord compression, meningeal metastasis\u002Fcancer meningitis, accompanied by brain metastasis symptoms or symptoms\u002Fimage control time is less than 4 weeks;\n* Known allergies to research drugs or excipients;\n* Have received previous treatment for Epidermal Growth Factor Receptor (EGFR)\u002Fc-Mesenchymal-epithelial transition dual anti-ADC drugs;\n* Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;\n* According to the researcher's judgment, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.",{"count":204,"type":22},216,[25],"TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR\u002Fc-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.",[208],"Advanced Malignant Tumors","2026-01-18",{"date":211,"type":34},"2026-01-21",{"date":213,"type":34},"2025-07-15",{"date":215,"type":22},"2028-06",{"name":40,"class":41},19,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":237,"locationsCount":238},"100606755","phase-1-a-clinical-study-assessing-the-subcutaneous-formulation-of-tqb2934-for-injection-in-subjects-with-malignant-plasma-cell-tumors-100606755","NCT07179679","A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors","A Phase I Clinical Study to Evaluate the Safety and Pharmacokinetics of TQB2934 Subcutaneous Preparation for Injection in Subjects With Malignant Plasma Cell Tumors","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;\n* 18 years old≤age≤75 years old (calculated based on the date of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG) score 0\\~2 points; expected survival is greater than 12 weeks;\n* Subjects with multiple myeloma must meet: 1) have a diagnostic record and meet the International Myeloma Working Group Relapsed (IMWG) diagnostic criteria; 2) there is a measurable lesion; 3) Refractory Multiple Myeloma (RRMM) has received at least one line of treatment, and at least one proteasome inhibitor (PI), an immunomodulator (IMiD) and a Cluster of Differentiation 38 (CD38) monoclonal antibody are refractory; 4) disease progression within 12 months after the last treatment or treatment;\n* Laboratory inspection standards that meet the program requirements;\n* Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that serum or urine pregnancy tests will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;\n\nExclusion Criteria:\n\n* Diagnosed with amyloidosis, active plasma cell leukemia (PCL, peripheral plasma cell proportion ≥5%, or absolute peripheral plasma cell count ≥0.5×109\u002FL), Fahrenheit macroglobulinemia (WM) or POEMS syndrome and other plasma cell tumors;\n* Have received allogeneic hematopoietic stem cell transplantation within 1 year before the first medication, or have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first medication;\n* Those who are known to have invasion of meninges or central nervous system or are highly suspected of invasion of meninges or central nervous system but cannot be identified;\n* Have received CD3×BCMA dual anti-anti-treatment in the past;\n* Cumulative treatment of dexamethasone \\>160 mg or equivalent dose of other glucocorticoids within 4 weeks before the first medication, or received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeks before the first medication, or received proteasome inhibitor therapy or radiotherapy within 2 weeks before the first medication, or received immunomodulatory therapy within 1 week before the first medication;\n* Those who have received Chinese patent medicine treatments within 2 weeks before the first medication have received National Medical Products Administration (NMPA) -approved drug instructions that clearly have anti-tumor indications;\n* Those who have a history of live attenuated vaccination within 4 weeks before the first medication or plan to undergo live attenuated vaccination during the study period;\n* A person with a history of severe allergies of unknown causes, or known to be allergic to monoclonal antibody drugs or exogenous human immunoglobulin, or known to be allergic to TQB2934 for injection or excipients in drug preparations;\n* Have appeared within 3 years before the first medication or are currently suffering from other malignant tumors;\n* Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE level 1 caused by any previous treatment, excluding hair loss, fatigue and peripheral neuropathy;\n* Those who have received major surgical treatment, obvious traumatic injury or expected research treatment within 4 weeks before the first medication, or have long-term uncured wounds or fractures;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* People with a history of abuse of psychotropic substances and cannot quit or have mental disorders, or suffer from epilepsy and need treatment;\n* Those with poor blood pressure control;\n* People with poor diabetes control;\n* People with severe bacterial, viral or systemic fungal infections that are active or uncontrollable within 4 weeks before the first medication;\n* People with hepatitis or decompensated cirrhosis;\n* People with active tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radioactive pneumonia that needs treatment, or active pneumonia with clinical symptoms;\n* People who have had or are currently suffering from asthma within 2 years before the first medication, or who have chronic obstructive pulmonary disease (COPD) and have a forceful exhalation volume (FEV1) in the first second \\\u003C50% expected value;\n* Those who have had asthma within 2 years before the first medication or are currently suffering from asthma;\n* People suffering from major cardiovascular diseases;\n* Have a history of immunodeficiency;\n* According to the researcher's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or subjects who believe there are other reasons that are not suitable for enrollment;",{"count":226,"type":22},42,[25],"TQB2934 is an anti-Cluster of Differentiation 3 (CD3) (Early T Cell Marker)×B cell maturation antigen (BCMA) double-specific antibody，and the isoform is IgG1(Native Immunoglobulin G1), which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA(B cell maturation antigen) to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells.\n\nTQB2934 for injection (subcutaneous injection) is intended for the treatment of patients with multiple myeloma.",[230],"Multiple Myeloma","2025-12-10",{"date":233,"type":34},"2025-12-11",{"date":235,"type":34},"2025-12-09",{"date":215,"type":22},{"name":40,"class":41},14,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100579530","phase-1-clinical-studies-for-the-treatment-of-advanced-solid-tumors-100579530","NCT06825494","Clinical Studies for the Treatment of Advanced Solid Tumors","An Open-label Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab + Chemotherapy in Patients With Advanced Solid Tumors - Cohort A","Inclusion Criteria:\n\n1. Be at least 18 years old.\n2. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1.\n3. At least 1 measurable lesion as determined by RECIST v1.1 assessment. Positron emission tomography (PET) scans and ultrasonography cannot be used for diagnostic purposes.\n4. All acute toxicities due to prior antineoplastic therapy or surgery have resolved to Grade 0-1 (according to NCI-CTCAE v5.0) or to the level specified by the enrollment\u002Fexclusion criteria. Other toxicities that, in the opinion of the investigator, do not pose a safety risk to the participant, such as alopecia, fatigue, and hearing loss, are excluded.\n5. Have adequate organ and bone marrow function, defined below:\n\n   1. Routine blood tests: (no transfusion, no granulocyte colony-stimulating factor (G-CSF), no drug correction) white blood cell count (WBC) ≥ 3,000\u002Fmm3 (3.0 × 109\u002FL), neutrophil count (ANC) ≥ 1,500\u002Fmm3 (1.5 × 109\u002FL), platelet count (PLT) ≥ 100,000\u002Fmm3 (100 × 109\u002FL), hemoglobin (Hb) ≥ 9.0 g\u002FdL (90 g\u002FL);\n   2. Biochemical tests: serum albumin ≥ 3.0 g\u002FdL (30 g\u002FL), serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml\u002Fmin (calculated using the Cockcroft-Gault formula), total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) levels ≤ 2.5 times the upper limit of normal (ULN), and patients with liver metastases should ≤ 5× ULN;\n   3. The international normalized ratio (INR) is ≤ 1.5, and the prothrombin time (PT) and activated partial thromboplastin time (APTT) are ≤ 1.5 times ULN;\n   4. Urine protein\\\u003C 2+; If the urine protein ≥ 2+, the 24-hour urine protein quantification shows that the protein must be ≤ 1 g;\n   5. Cardiac function: left ventricular ejection fraction ≥ 50% on echocardiography.\n6. Expected survival ≥ 12 weeks;\n7. Non-childbearing is defined as a woman who has reached a postmenopausal state, or who has had a medically documented bilateral oophorectomy. Male participants and female participants of childbearing potential must agree to use 1 medically approved form of contraception for the duration of the trial and for 6 months after the last dose of the trial drug or 9 months after the last dose of the chemotherapy drug (oxaliplatin), whichever is later, and a negative serum pregnancy test within 3 days prior to starting the study drug and not lactating.\n8. With the consent of the person and has signed the informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests, and other trial procedures.\n\n   Enrollment criteria applicable to each cohort:\n\n   Cohorts A1 and A2 must meet the following enrollment criteria:\n9. Patients with a pathologically confirmed diagnosis of Gastric cancer (GC) or Gastroesophageal junction cancer (GEJC), evidence of unresectable advanced or metastatic disease, and histologic confirmation of adenocarcinoma.\n10. Provide negative reports of human epidermal growth factor receptor 2 (HER2) overexpression or amplification; HER2 overexpression or amplification negative is defined as Immunohistochemistry (IHC) 0\u002F1+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH)\u002FIn Situ Hybridization (ISH) negative.\n11. No prior systemic therapy (including anti-HER-2 therapy) for advanced or metastatic GC\u002FGEJC. Patients who have received prior adjuvant or neoadjuvant therapy for GC\u002FGEJC (including: chemotherapy, radiotherapy, or chemoradiotherapy) have a time of first recurrence or disease progression greater than 6 months from the end of the last treatment. Participants who have previously received anti-tumor traditional Chinese medicine preparations are allowed, but must be discontinued at least 14 days prior to enrollment.\n12. Participants should provide tumor tissue samples: fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue, or microneedle aspiration tissue collected at radiotherapy-naïve sites within approximately 24 months prior to enrollment (specimens within 6 months prior to the first dose of study drug are recommended and no systemic therapy has been received since the sample was obtained). For participants who are unable to provide tissue samples but meet other enrollment conditions, the investigator and the sponsor will jointly decide whether to enroll.\n\n    Cohorts A3 and A4 need to meet the following enrollment criteria:\n13. Patients with pathologically confirmed solid tumors with evidence of advanced or metastatic unresectable disease.\n14. Patients with advanced or metastatic solid tumors who have failed at least one prior line of standard therapy. Participants who have previously received anti-tumor traditional Chinese medicine preparations are allowed, but must be discontinued at least 14 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Microsatellite Instability-High (MSI-H)\u002Fdeficient Mismatch Repair (dMMR) is known.\n2. Presence of uncontrolled or symptomatic active central nervous system metastases that can manifest as the presence of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and\u002For progressive growth. Central Nervous System (CNS) metastases may be enrolled in the study if they have been adequately treated (surgical or radiographed) and neurological symptoms have returned to baseline (except for residual signs or symptoms associated with CNS treatment) by at least 14 days prior to enrollment.\n3. Pleural effusion and ascites that cannot be controlled after puncture and drainage and other treatments within 14 days prior to enrollment; Pericardial effusion with clinical symptoms or moderate or above.\n4. Participant weight loss of more than 20% in 2 months prior to enrollment.\n5. Participant weight loss of more than 20% in 2 months prior to enrollment:\n\n   1. Received Chemokine receptor 8 (CCR8) antibody, Cytotoxic T-lymphocyte-Associated Protein-4 (CTLA-4) antibody, or other drugs that act on Treg before enrollment.\n   2. Major surgery within 28 days prior to enrollment (tissue biopsy and peripherally venipuncture central venous catheter placement \\[Peripherally Inserted Central Venous Catheters (PICC)\\]\u002Fport implantation required for diagnosis are permitted).\n   3. Use of immunosuppressive medications, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg\u002Fd prednisone or equivalent pharmacophysiological doses of other corticosteroids) within 14 days prior to enrollment.\n   4. Live attenuated vaccine within 28 days prior to enrollment or planned administration during the study and within 60 days after the end of study drug treatment.\n   5. Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days prior to enrollment.\n6. Diagnosis of any other malignancy within 5 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has a clear medical record documented as cured, except for basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid gland.\n7. Presence of any active, known or suspected autoimmune disease. Participants who are in a stable state and do not require systemic immunosuppressive therapy, such as: type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, and alopecia) are allowed.\n8. Significant clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; Arterial\u002Fvenous thrombotic events occurred within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.\n9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to enrollment.\n10. Severe, non-healing, or dehiscence wounds and active ulcers or untreated fractures.\n11. Presence of grade \\>1 peripheral neuropathy.\n12. Gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months prior to enrollment;\n13. Previous intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment, including incomplete obstruction related to a pre-existing condition or requiring routine parenteral hydration, parenteral nutrition, or tube feeding: Patients may be allowed to be enrolled in the study if at the time of initial diagnosis if the patient has received definitive (surgical) treatment to resolve symptoms.\n14. Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.).\n15. Known hypersensitivity to the study drug or any of its excipients; or have had a severe allergic reaction to other monoclonal antibodies.\n16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as Hepatitis B Virus (HBV)-DNA ≥ 500 IU\u002Fml; Hepatitis C, defined as Hepatitis C Virus (HCV)-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C.\n17. Presence of cardiac clinical symptoms or disease that is not well controlled:\n\n    1. Cardiac insufficiency of grade 2 and above according to the New York Heart Association (NYHA) criteria.\n    2. Corrected QT Interval (QTc) \\> 480 ms; The QTc interval was calculated using the Fridericia formula.\n    3. Severe\u002Funstable angina.\n    4. Myocardial infarction occurred within 12 months prior to enrollment.\n    5. Clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure.\n18. Systemic antibiotic use within 28 days prior to enrollment for ≥ 7 days, or unexplained fever \\>38.5°C during screening\u002Fbefore the first dose (as judged by the investigator, fever due to tumor causes can be enrolled).\n19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n20. Participation in any other drug clinical study within 4 weeks prior to enrollment, or no more than 5 half-lives from the last study drug.\n21. Known history of psychotropic substance abuse or drug abuse.\n22. Presence of other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.",{"count":247,"type":22},194,[25,26],"This trial is part of a multicenter, open-label Phase Ib\u002FII clinical study evaluating the efficacy, safety, and tolerability of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors. Phase Ib of Cohort A1 determines the dose of LM-108 in combination with penpulimab + oxaliplatin + capecitabine. Phase II explores the efficacy and safety of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors.",[55],{"date":252,"type":34},"2025-12-18",{"date":254,"type":34},"2025-04-08",{"date":256,"type":22},"2026-09",{"name":40,"class":41},32,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":7},"100554238","phase-2-a-clinical-trial-of-tqb2102-for-injection-in-non-small-cell-lung-cancer-with-her2-gene-abnormality-100554238","NCT06496490","A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality","A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign informed consent;\n* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;\n* Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;\n* Previous standard treatments failed；\n* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);\n* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Has diagnosed and\u002For treated additional malignancy within 3 years prior to take medication;\n* Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);\n* Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;\n* Long-term unhealed wounds or fractures;\n* History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;\n* Arterial\u002Fdeep vein thrombosis events occurred within 6 months prior to treatment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;\n* Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;\n* Patients with any severe and\u002For uncontrolled disease;\n* Any anticancer therapy or any other investigational drug treatment within 28 days or 5 half-lives prior to the first dosing of this study;\n* Within 1 week prior to the first administration of this study, the Chinese patent drugs with anti-tumor indications clearly stated in the National MedicalProducts Administration approved drug instructions were treated;\n* Local focal palliative radiotherapy was received within 2 weeks before the first dose;\n* Patients with serous effusion requiring repeated drainage to relieve clinical symptoms or who have received serous effusion drainage for therapeutic purposes within 2 weeks prior to treatment;\n* There is symptomatic or progressive exacerbation of central nervous system metastatic or cancerous meningitis with diffuse spread. Subjects with a history of brain metastases may be considered for inclusion if they are clinically stable;\n* Severe bone injury caused by tumor bone metastasis, including pathological fractures and spinal cord compression that occurred within 6 months or are likely to occur in the near future;\n* Pain associated with uncontrolled bone metastases;\n* Allergic to humanized monoclonal antibody products;\n* Allergic to any investigational drug or to any ingredient or excipient in the drug;\n* Persons who have received live attenuated vaccine within 4 weeks prior to treatment;\n* Subjects who, in the investigator's judgment, have concomitant diseases that seriously endanger the safety of subjects or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.",{"count":267,"type":22},270,[26],"TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.",[271],"Non-Small Cell Lung Cancer","2025-11-18",{"date":274,"type":34},"2025-11-20",{"date":276,"type":34},"2024-08-06",{"date":278,"type":22},"2026-12",{"name":40,"class":41},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},"100575094","phase-2-clinical-study-of-tqb2868-injection-combined-with-anlotinib-capsule-and-chemotherapy-in-the-first-line-treatment-of-metastatic-pancreatic-neoplasms-100575094","NCT06767813","Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms","Multi-cohort, Open, Phase II Clinical Study of TQB2868 Injection Combined With Arotinib Capsule and Chemotherapy in the First-line Treatment of Pancreatic Neoplasms","Inclusion Criteria:\n\n* Subjects must voluntarily participate in the study and sign the informed consent form.\n* Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.\n* Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation.\n* Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria;\n* No prior systemic anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Patients who experience disease progression more than 6 months after completing neoadjuvant or adjuvant therapy are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of more than 3 months.\n* Normal major organ function.\n* Patients must use reliable contraception during the study period and for 6 months after the end of the study period; Female participants must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n* Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years.\n* Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia.\n* Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose.\n* Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose.\n* Arterial or venous thrombotic events within 6 months prior to the first dose.\n* Active gastric or duodenal ulcers, perforations, persistent positive fecal occult blood tests, ulcerative colitis, or other gastrointestinal bleeding conditions within 6 months prior to the first dose; or other bleeding conditions as assessed by the investigator.\n* Hepatitis B virus (HBV)-infected patients unable to adhere to consistent antiviral therapy, or Hepatitis C virus (HCV)-infected patients (positive for HCV Ab or HCV RNA) deemed unstable by the investigator or requiring continued antiviral therapy without consistent adherence.\n* History of substance abuse involving psychotropic drugs that cannot be discontinued or presence of psychiatric disorders.\n* Symptomatic interstitial lung disease or conditions likely to cause drug-induced lung toxicity or related pneumonitis.\n* Presence of any severe and\u002For uncontrolled diseases.\n* Histological or cytological confirmation of other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, or pancreatoblastoma.\n* Tumors confirmed via imaging (CT or MRI) to have invaded major blood vessels, with the investigator deeming a high likelihood of fatal hemorrhage during the study.\n* Tumors confirmed via imaging (CT or MRI) to have invaded the gastrointestinal tract, with a high risk of bleeding based on endoscopy and investigator assessment.\n* Known central nervous system metastases and\u002For carcinomatous meningitis.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, as assessed by the investigator.\n* History of severe allergic reactions to biologic agents or known hypersensitivity to any component of TQB2868 injection.\n* Chronic treatment with systemic corticosteroids or other immunosuppressive agents within 28 days prior to the first dose, and continued use of such medications within 2 weeks after the first dose.\n* Receipt of live attenuated vaccines within 28 days prior to the first dose or planned administration of live attenuated vaccines during the study.\n* Systemic therapy required within 2 years prior to the first dose for any condition. Alternative therapies are not considered systemic therapy.\n* Participation in other clinical trials involving anti-tumor drugs within 28 days prior to the first dose.\n* Any comorbidities or conditions deemed by the investigator to pose severe risks to the subject's safety or the completion of the study, or any other reasons rendering the subject unsuitable for enrollment.",{"count":288,"type":22},80,[26],"To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms",[292],"Pancreatic Neoplasms",{"date":294,"type":34},"2025-09-19",{"date":296,"type":34},"2024-03-19",{"date":298,"type":22},"2026-11",{"name":40,"class":41},7,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},"100596396","phase-1-tqb2922-and-tas-102-tablets-for-injection-with-or-without-bevacizumab-in-chemotherapy-failed-rasbraf-wild-type-advanced-colorectal-cancer-100596396","NCT07044908","TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS\u002FBRAF Wild-type Advanced Colorectal Cancer","A Phase Ib\u002FII Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS\u002FBRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy","Inclusion Criteria:\n\n* Subjects voluntarily enrolled in the study, signed the informed consent and had good compliance;\n* Age: 18-75 years old (including boundaries at the time of signing the informed consent);\n* Eastern Cooperative Oncology Group (ECOG) score: 0-1;\n* Expected survival of more than 3 months;\n* Unresectable locally advanced or metastatic colorectal cancer diagnosed by histological\u002Fcytological pathology;\n* Disease progression or intolerable after prior treatment with oxaliplatin, fluorouracil-based and irinotecan and treated with cetuximab or bevacizumab;\n* Patients with genetic testing showing wild-type for both rat sarcoma (RAS) and B-type rapid response protein kinase (BRAF);\n* Presence of at least 1 measurable lesion according to RECIST 1.1 criteria;\n* Laboratory tests meet the criteria;\n* Female subjects of childbearing potential must agree to use contraception (e.g., Intrauterine Device (IUD), birth control pills, or condoms) for the duration of the study and for 6 months after the end of the study; must have a negative serum pregnancy\u002Furine pregnancy test\n* within 7 days prior to study entry and must not be breastfeeding; male subjects must agree to use contraception for the duration of the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n* Patients who have had previous confirmation of microsatellite high instability\u002Fmismatch repair defects (MSI-H\u002FdMMR) by immunohistochemistry (IHC), next-generation sequencing (NGS) or polymerase chain reaction (PCR);\n* Presence of a disease that interferes with intravenous administration, intravenous blood collection, or multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction);\n* Active inflammatory bowel disease (ulcerative colitis, Crohn's disease) within 28 days prior to first dose;\n* The presence or current concurrent presence of other malignancies within 2 years prior to the first dose.\n* Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to any prior therapy, excluding alopecia, fatigue and peripheral neuropathy;\n* Major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to first dose;\n* The presence of a long-standing unhealed wound or fracture;\n* Cerebrovascular accident (including temporary ischaemic attack, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months prior to the first dose;\n* Have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;\n* Subjects with any severe and\u002For uncontrolled medical condition, including:\n\n  * Unsatisfactory control of blood pressure (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, at least 2 measurements taken at intervals of more than 24h);\n  * Myocardial infarction, unstable angina pectoris, stable angina pectoris ≥ Grade 2, heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification), arrhythmia ≥ Grade 2;\n  * Active or uncontrolled severe bacterial, viral, or systemic fungal infection (≥ CTC AE grade 2 infection) within 28 days prior to first dose; patients with active tuberculosis within 1 year prior to enrolment.\n  * Active viral hepatitis with poor control. Subjects will be screened if they meet the following requirements: Hepatitis B surface antigen (HBsAg) positive subjects with Hepatitis B virus (HBV) DNA quantification \\\u003C2000 IU\u002Fml (or 1\\*10 4 copy\u002Fml) or at least 1 week of anti-HBV treatment with a 10-fold (1 log) or greater reduction in viral index prior to study entry. Subject is willing to remain on anti-HBV therapy for the entire duration of the study; HCV-infected patients (HCV Ab or HCV RNA positive) who are judged to be stable by the investigator or who are on antiviral therapy at the time of enrolment and who continue to receive approved antiviral therapy during the study;\n  * Subjects with a history of (non-infectious) interstitial lung disease requiring systemic steroid therapy, or current interstitial lung disease\u002Finterstitial pneumonia; or subjects with Screening Imaging suggestive of suspected interstitial lung disease\u002Finterstitial pneumonia that cannot be ruled out;\n  * History of immunodeficiency, including being human immunodeficiency virus (HIV) positive or having other acquired, congenital immunodeficiency diseases;\n  * Poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\> 10 mmol\u002FL); and\n  * Active syphilis infection.\n* Known tumour-associated spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks;\n* Imaging suggestive of tumour invasion of large blood vessels or, in the judgement of the investigator, there is a high probability of tumour rupture or invasion of vital blood vessels during the study period leading to fatal haemorrhage;\n* Failure to control a plasma (thoracic, abdominal, or pericardial) effusion that requires repeated drainage;\n* Local radiotherapy within 2 weeks or \\>30% bone marrow irradiation radiotherapy for bone metastases within 4 weeks prior to first dose.\n* Chemotherapy, targeted therapy, immunotherapy, or other antineoplastic agents within 4 weeks prior to the first dose, or who are still on drug 5.\n\ntreatment, or subjects who are still within 5 half-lives of the drug (whichever occurs first);\n\n* Prior use of epidermal growth factor receptor\u002Fc-mesenchymal epidermal transforming factor (EGFR\u002Fc-Met) dual-antibody drugs;\n* Received treatment with a proprietary Chinese medicine with an anti-tumour indication as specified in the National Drug\n* Administration (NMPA) approved drug insert within 1 week prior to study treatment.\n* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study period.",{"count":309,"type":22},72,[25,26],"This is a multicenter, open Phase Ib\u002FII clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS\u002FBRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.",[313],"RAS\u002FBRAF Wild Type Colorectal Cancer","2025-08-11",{"date":316,"type":34},"2025-08-12",{"date":318,"type":34},"2025-07-30",{"date":320,"type":22},"2027-07",{"name":40,"class":41},27,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":343},"100593633","phase-3-clinical-trial-of-tqb2102-for-injection-versus-trastuzumab-emtansine-for-injection-in-her2-positive-advanced-breast-cancer-100593633","NCT07008976","Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer","A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer","Inclusion Criteria:\n\n* The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;\n* Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months;\n* HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination;\n* According to the 2018 version of the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive;\n* The hormone receptor (HR) status has been clearly determined:\n\n  a) According to the 2020 version of the ASCO\u002FCAP guidelines, HR positive includes ER positive and\u002For PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%.\n* Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence\u002Fmetastasis stage.\n* Disease progression occurred during or after the most recent treatment or intolerance.\n* At least 1 line of treatment has been received in the recurrence\u002Fmetastasis stage.\n* According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists.\n\nExclusion Criteria:\n\n* Excluded are patients with known spinal cord compression or active central nervous system metastases .\n* Patients with only skin and\u002For intracranial lesions as target lesions.\n* Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1.\n* Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n* Patients with major cardiovascular diseases\n* Patients with a history of interstitial lung disease\u002Fpneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease\u002Fpneumonia, or those with suspected interstitial lung disease\u002Fpneumonia indicated by screening period imaging and cannot be excluded.",{"count":331,"type":22},246,[75],"This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.",[335],"Metastatic Breast Cancer","2025-08-10",{"date":338,"type":34},"2025-08-14",{"date":340,"type":34},"2025-07-07",{"date":38,"type":22},{"name":40,"class":41},31,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":64},"100601702","phase-1-a-clinical-trial-evaluating-tqb2101-in-subjects-with-advanced-hematologic-malignancies-100601702","NCT07113925","A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies","A Phase I Clinical Trial Evaluating the Safety and Efficacy of TQB2101 in Subjects With Advanced Hematologic Malignancies","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.\n* Age between 18 and 75 years (calculated based on the date of signing the informed consent form).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected survival \\>12 weeks.\n* Subjects with advanced hematologic malignancies confirmed by cytology\u002Fhistopathology, who have failed standard treatment or lack effective treatment options.\n* At least one measurable lesion according to the 2014 Lugano criteria: lymph node lesions with long axis \\>15mm or extranodal lesions with long axis \\>10mm on CT cross-sectional imaging.\n* Adequate organ function meeting the following criteria:\n\n  1. Hemoglobin (HGB) ≥80g\u002FL\n  2. Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL\n  3. Platelet count (PLT) ≥75×10⁹\u002FL (≥50×10⁹\u002FL if with bone marrow involvement)\n  4. Total bilirubin (TBIL) ≤1.5×ULN\n  5. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if with liver metastases)\n  6. Serum creatinine (CR) ≤1.5×ULN OR creatinine clearance rate (CCR) ≥60ml\u002Fmin (calculated using standard Cockcroft-Gault formula)\n  7. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤1.5×ULN (without anticoagulation therapy)\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with negative blood pregnancy test within 7 days prior to enrollment; male subjects must agree to use effective contraception during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n* Patients with other malignant tumors that occurred within 3 years before the first administration or currently coexisting with other malignant tumors are excluded, except for those who have undergone a single surgical treatment for other malignant tumors and have achieved a disease-free survival (DFS) of 5 consecutive years; patients with cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\] are eligible for inclusion.\n* Tumor-related symptoms and treatments:\n\n  1. Lymphoma involving or suspected to involve the central nervous system, or primary central nervous system lymphoma;\n  2. Patients who have received chemotherapy, immunotherapy within 4 weeks before the first administration, radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drug (whichever occurs earlier), with a washout period calculated from the end of the last treatment;\n  3. Patients who have received treatment with traditional Chinese medicine with clear anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Brucea javanica Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.) within 2 weeks before the first administration;\n  4. Patients who have previously received treatment with ROR1 inhibitor drugs;\n  5. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks before the first administration (calculated from the last use of the trial drug) and have used the trial drug, or are still within 5 half-lives of the study drug (whichever is shorter).\n* Patients with adverse reactions from previous treatments that have not recovered to a Common Terminology Criteria for Adverse Events Version 5.0 (CTC AE v5.0) grade score of ≤1, except for alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.\n* Patients who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (except for surgeries specified in the protocol) within 4 weeks before the first administration, or have long-term unhealed wounds or fractures.\n* Patients who have experienced any bleeding event ≥ CTC AE v5.0 grade 3 within 4 weeks before the first administration, or have bleeding or coagulation disorders and are using warfarin, aspirin, or other antiplatelet aggregation drugs (except for maintenance doses: aspirin ≤ 100mg\u002Fd, clopidogrel ≤ 75mg\u002Fd), or have any bleeding signs or history judged by the investigator to be unsuitable for inclusion.\n* Patients who have experienced arterial or venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.\n* Patients with decompensated liver cirrhosis (Child-Pugh liver function rating of B or C), active chronic hepatitis B, or active hepatitis C: HbsAg positive and hepatitis B virus (HBV) DNA positive or with a detection value exceeding the lower limit of detection; HCV antibody positive and HCV RNA positive or with a detection value exceeding the lower limit of detection.\n\nNote: For eligible HbsAg positive patients with hepatitis B, regardless of whether HBV DNA is detectable, continuous antiviral treatment (recommended nucleotide analogues) and regular monitoring of HBV DNA are required; for patients with positive HBcAb but negative HbsAg, regular monitoring of HBV DNA is required, and preventive antiviral treatment is recommended; for patients with hepatitis C, regular monitoring of hepatitis C virus (HCV) RNA is required.\n\n* Patients with active syphilis requiring treatment.\n* Patients with active pulmonary tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms. (10) Subjects with a history of substance abuse of psychotropic drugs and unable to quit or with mental disorders.\n* Subjects with a history of decompensated liver cirrhosis and hepatic encephalopathy.\n* Subjects with clinically significant cardiovascular diseases, including any of the following conditions:\n\n  1. Subjects who have experienced acute myocardial infarction or severe\u002Funstable angina within 6 months before the start of study treatment; or subjects with New York Heart Association (NYHA) functional classification of grade 2 or higher heart failure;\n  2. Subjects with prolonged QT interval corrected by the Fridericia formula (QTcF) at rest, with QTc ≥ 450 ms (male) or QTc ≥ 470 ms (female);\n  3. Subjects with a history of or ongoing severe uncontrolled ventricular arrhythmias requiring drug treatment;\n  4. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  5. Congenital long QT syndrome or any known history of torsades de pointes (TdP);\n  6. Uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg), or a history of hypertensive encephalopathy\u002Fhypertensive crisis.\n* Subjects with active or uncontrolled severe infections (≥ CTC AE v5.0 grade 2 infection).\n* Subjects with renal failure requiring hemodialysis or peritoneal dialysis.\n* Subjects with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases.\n* Subjects with (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment or currently having non-infectious pneumonia\u002Finterstitial lung disease or having been hospitalized or treated with therapeutic antibiotics for any active infection within 4 weeks before the start of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n* Subjects with a history of or current central nervous system diseases, including but not limited to epilepsy, hemorrhagic\u002Fischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, paralysis, aphasia, mental disorders, consciousness disorders, unexplained coma, neuropathy, organic brain syndrome, etc.; and subjects who have experienced cerebrovascular accidents, cerebral infarction, etc. within 6 months before the first dose.\n* Subjects with urine protein ≥ ++ in routine urine test and confirmed 24-hour urine protein quantification \\> 1.0 g.\n* Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL).\n* Uncontrolled pleural, peritoneal or pericardial effusion requiring repeated drainage or with obvious symptoms. Subjects with only a small amount of pleural effusion, ascites or pericardial effusion shown on imaging, without symptoms and without drainage or other treatment within 2 weeks before enrollment, can be enrolled.\n* Subjects known to be allergic to the excipients of the study drug.\n* Subjects, as judged by the investigator, with conditions that seriously endanger the safety of the subject or affect the subject's ability to complete the study.",{"count":352,"type":22},114,[25],"TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.",[356],"Advanced Hematologic Malignancies","2025-08-08",{"date":314,"type":34},{"date":360,"type":34},"2025-08-01",{"date":215,"type":22},{"name":40,"class":41},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100575093","phase-2-a-clinical-trial-evaluating-tqb2102-for-injection-in-combination-with-behmosubaisumabpayamprolizumab-with-or-without-chemotherapy-in-unresectable-locally-advanced-recurrent-or-metastatic-human-epidermal-growth-factor-receptor-2-her2-positive-gastroesophageal-adenocarcinoma-100575093","NCT06767800","A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab\u002FPayamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma","Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection in Chemotherapy With Behmosubstituted Monoclonalb\u002FPembrolizumab ± Chemotherapy in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy≥3 months;\n* Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma;\n* HER2 expression levels of Immunohistochemistry(IHC) 3+ or IHC 2+ and In Situ Hybridization (ISH) positivity were confirmed in tumor tissue;\n* Subject is able to provide previous compliant PD-L1 expression level test results or is able to provide sufficient and competent tumor tissue for PD-L1 expression level testing;\n* Patients who have not received prior systemic therapy for locally advanced or metastatic gastric cancer and who have experienced tumor recurrence or metastasis at least 6 months after the completion of prior adjuvant or neoadjuvant therapy may be enrolled;\n* Confirmation of at least one measurable lesion according to RECIST 1.1 criteria;\n* The main organs function well;\n* Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;\n* Uncontrollable toxic reactions above CTC AE grade 1 due to any prior therapy, excluding alopecia;\n* Major surgical treatment, incisional biopsy or significant traumatic injury or prolonged unhealed wound or fracture within 28 days prior to first dose;\n* Prior history of interstitial lung disease\u002Fpneumonia (non-infectious) requiring steroidal drug intervention or current concomitant (or suspected) interstitial lung disease\u002Fpneumonia;\n* Arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, have occurred within 6 months prior to the first dose;\n* Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;\n* Subjects with the presence of any severe and\u002For uncontrolled disease；\n* Subjects who have received other antitumor drugs such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, or who are still within the 5 half-life of the drug (whichever occurs shortest); have received a proprietary Chinese medicine with an antitumor indication as specified in the National Medical Products Administration(NMPA) -approved drug insert within 2 weeks prior to the first dose; and have experienced any hemorrhagic or bleeding event in the month prior to the initiation of study treatment ≥CTC Patients with AE grade 3;\n* Subjects with known Central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Presence of severe bone damage and spinal cord compression due to tumor bone metastases;\n* History of live attenuated vaccination within 28 days prior to the first dose or planned live attenuated vaccination during the study;\n* History of severe hypersensitivity reactions to large molecule drugs or hypersensitivity to known components of TQB2102, benmelstobart or pembrolizumab for injection;\n* Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose of medication\n* Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy that was continued within 2 weeks prior to initiation of study treatment.\n* Participants who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication use\n* Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.",{"count":371,"type":22},204,[26],"TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection \u002FPenpulimab Injection ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma",[375],"Gastroesophageal Adenocarcinoma","2025-07-28",{"date":318,"type":34},{"date":379,"type":34},"2024-11-21",{"date":381,"type":22},"2027-09",{"name":40,"class":41},39,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":391,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":343},"100577431","phase-2-a-clinical-trial-of-tqb2102-for-injection-in-gynecological-tumors-with-recurrentmetastatic-advanced-100577431","NCT06798207","A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent\u002FMetastatic Advanced","A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent\u002FMetastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study, sign informed consent and have good compliance.\n* The age is ≥ 18 years old (subject to the date of signing the informed consent); Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survival time ≥ 3 months ;\n* Histologically confirmed, unresectable recurrent \u002F metastatic advanced gynecologic tumors;\n* The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue, and the subjects with completely negative IHC 0 staining are excluded.\n* Previous chemotherapy with platinum-based drugs was unsuccessful.\n* There is at least one measurable lesion according to the RECIST 1.1 criteria; women of childbearing potential need to meet the following conditions: the serum\u002Furine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.\n\nExclusion Criteria:\n\n* Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously.\n* Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia.\n* Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before the start of treatment.\n* Long-term unhealed wounds or fractures.\n* Subjects with a history of interstitial lung disease\u002Fpneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currently accompanied by interstitial lung disease\u002Fpneumonia, or those with suspected interstitial lung disease\u002Fpneumonia indicated by screening imaging and cannot be excluded.\n* Subjects with moderate to severe pulmonary dysfunction\u002Fdisease within 3 months before the first administration.\n* Arterial\u002Fdeep vein thrombosis events occurred within 6 months before treatment, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.\n* Subjects with any severe and\u002For uncontrolled diseases.\n* Patients with local recurrence suitable for surgery or radiotherapy.\n* Those with disease progression after receiving chemotherapy drugs of topoisomerase I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment.\n* Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study.\n* Received treatment with Chinese patent medicines with clear anti-tumor indications in the drug instructions approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration in this study.\n* Serosal effusion that requires repeated drainage to relieve clinical symptoms, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment.\n* Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs.\n* Subjects with known central nervous system metastasis and\u002For carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may be considered for inclusion if clinically stable.\n* Severe bone damage and spinal cord compression caused by tumor bone metastasis, including weight-bearing bone pathological fractures that occurred within 6 months or are likely to occur in the near future, poorly controlled severe bone pain, etc.\n* Those allergic to macromolecular drug components or allergic to any research drug, any component or excipient in the drug.\n* Received live attenuated vaccines within 4 weeks before treatment.\n* Active autoimmune diseases that required systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration.\n* Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.","FEMALE",{"count":393,"type":22},170,[26],"TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent\u002Fmetastatic advanced gynecological tumors.",[397],"Gynecological Tumors","2025-07-16",{"date":400,"type":34},"2025-07-18",{"date":402,"type":34},"2025-03-13",{"date":298,"type":22},{"name":40,"class":41},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":7},"100593179","phase-3-a-clinical-study-of-tqb2102-versus-docetaxel-plus-trastuzumab-and-pertuzumab-in-the-treatment-of-her2-positive-recurrent-or-metastatic-breast-cancer-100593179","NCT07003074","A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer","A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects voluntarily enrolled in this study with good compliance\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1\n* HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology\n* Defined hormone receptor (HR) status\n* Has not received systemic anti-tumor therapy during the recurrence\u002Fmetastasis stage (acceptable ≤ first-line endocrine therapy)\n* If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence\u002Fmetastasis be greater than 12 months\n* Have at least one measurable lesion according to RECIST 1.1 criteria;\n* Good major organ function\n\nExclusion Criteria:\n\n* It is known that there is spinal cord compression or active central nervous system metastasis;\n* Subjects with only skin and\u002For brain lesions as target lesions\n* Combined diseases and medical history\n\n  1. Have had or currently have other malignant tumors within the past 5 years of randomization\n  2. Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment\n  3. Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization\n  4. There are diseases that affect intravenous injection and venous blood collection\n  5. There are congenital bleeding and coagulation disorders present\n  6. An arterial\u002Fdeep vein thrombosis event occurred within 6 months prior to the first administration\n  7. Poor blood pressure control\n  8. Suffering from significant cardiovascular disease\n  9. There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment\n  10. History of interstitial lung disease\u002Fpneumonia (non infectious) requiring steroid medication intervention in the past\n  11. Individuals with moderate to severe pulmonary dysfunction\u002Fdisease within 3 months prior to the first administration\n  12. Active viral hepatitis with poor control\n  13. Active syphilis infected individuals in need of treatment\n  14. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation\n  15. Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression\n  16. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases\n  17. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g\n  18. Patients with renal failure requiring hemodialysis or peritoneal dialysis\n  19. Poor control of diabetes\n  20. Individuals with epilepsy who require treatment\n  21. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders\n* Tumor related symptoms and treatment\n\n  1. There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods\n  2. History of cumulative dose exposure to anthracyclines in the past\n  3. Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment\n  4. Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment\n* Research treatment related\n\n  1. Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;\n  2. Allergic to any research drug or any ingredient or excipient in the drug;\n  3. Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;\n  4. Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.\n* According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.",{"count":413,"type":22},642,[75],"This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.",[417],"Breast Cancer","2025-06-24",{"date":420,"type":34},"2025-06-25",{"date":422,"type":34},"2025-06-23",{"date":424,"type":22},"2030-07",{"name":40,"class":41},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100590042","phase-2-a-clinical-study-on-the-first-line-treatment-of-metastatic-pancreatic-cancer-with-tqb2916-injection-combined-with-gemcitabine-hydrochloride-for-injection-and-paclitaxel-for-injection-albumin-bound-type-100590042","NCT06962267","A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)","A Phase II Clinical Study to Evaluate the Efficacy and Safety of TQB2916 Injection Combined With Gemcitabine and Albumin-paclitaxel as First-line Treatment for Metastatic Pancreatic Cance","Inclusion Criteria:\n\n* The subjects voluntarily joined this study and signed the informed consent form;\n* Age: 18-75 years old (the time of signing the informed consent form, including the critical value);\n* Pancreatic ductal adenocarcinoma confirmed by tissue or cytology (excluding other mixed pancreatic cancers);\n* Have at least one measurable lesion according to the RECIST 1.1 standard;\n* Without any systematic anti-tumor treatment;\n* The Eastern Cooperative Oncology Group (ECOG) score is 0-1, and the expected survival period is more than 3 months;\n* The main organs function well;\n* Patients must adopt reliable contraceptive measures during the study period and within 6 months after the end of the study period;The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating.\n\nExclusion Criteria:\n\n* Comorbid diseases and medical history:\n\n  1. Within 5 years, the subject has had or simultaneously suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);Patients with other malignant tumors, but the following two situations can be enrolled: other malignant tumors treated by single surgery, achieving R0 resection and no recurrence or metastasis within 5 years;Cured cervical carcinoma in situ, cutaneous basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)\\];\n  2. Unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 caused by any previous treatment, excluding alopecia;\n  3. Have received major surgical treatment, obvious traumatic injury, or have long-term unhealed wounds or fractures within 28 days before the first medication;\n  4. Patients who experienced any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first administration;\n  5. Those who have experienced hyperarterial\u002Fvenous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.\n  6. hepatitis B virus (HBV) virus-infected individuals cannot receive regular antiviral treatment throughout the entire course.Hcv-infected individuals (HCV Ab or HCV RNA positive) : Researchers determine that they are in an unstable state or need to continue antiviral treatment. They cannot receive regular antiviral treatment in the study.\n  7. Active syphilis patients;\n  8. Those with a history of abuse of psychotropic drugs and who are unable to quit or have mental disorders;\n  9. Symptomatic interstitial lung disease, as well as conditions that may cause drug-induced pulmonary toxicity or associated pneumonia;\n  10. Subjects with any severe and\u002For uncontrolled diseases.\n* Tumor-related symptoms and treatments:\n\n  1. Imaging (CT or MRI) shows that the tumor has invaded around important blood vessels, and the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period;\n  2. Subjects with known central nervous system metastases and\u002For cancerous meningitis;\n  3. Uncontrolled pleural effusion, pericardial effusion or ascites that still require repeated drainage (as determined by the researcher).\n* Research treatment-related:\n\n  1. There is a history of severe allergy to large molecule drugs in the past, or allergy to known components of TQB2916 injection;\n  2. Those who received chronic treatment with systemic hormones or other immunosuppressants (dose \\>10mg\u002F day prednisone or other equivalent therapeutic hormones) within 28 days before the start of administration in this study and still need to continue using hormones or immunosuppressants within 2 weeks after the first trial administration (except temporarily);\n  3. The history of attenuated live vaccine inoculation within 28 days before the start of the study treatment or the planned attenuated live vaccine inoculation during the study period;\n  4. An active autoimmune disease that required systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first medication.\n* Participated in clinical trials of other anti-tumor drugs within 28 days before the start of administration in this study;\n* Subjects who, based on the researcher's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to have other reasons and are not suitable for enrollment.",{"count":434,"type":22},50,[26],"This trial was a single-arm, open-label design to evaluate the efficacy and safety of \"TQB2916+ gemcitabine + albumin-paclitaxel\" as the first-line treatment for metastatic pancreatic cancer.",[438],"Pancreatic Cancer","2025-04-30",{"date":441,"type":34},"2025-05-08",{"date":443,"type":34},"2025-04-18",{"date":445,"type":22},"2027-10",{"name":40,"class":41},1,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":467,"locationsCount":447},"100588986","phase-1-to-evaluate-the-tolerability-and-pharmacokinetics-of-tqb2101-for-injection-in-patients-with-advanced-malignant-tumors-100588986","NCT06948539","To Evaluate the Tolerability and Pharmacokinetics of TQB2101 for Injection in Patients With Advanced Malignant Tumors","A Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2101 for Injection in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;\n* 18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);\n* Eastern Cooperative Oncology Group (ECOG) score 0\\~1;\n* Expected survival greater than 12 weeks;\n* Patients with advanced solid tumors confirmed by cytology\u002Fhistopathology, failure of standard treatment or lack of effective treatment ; Participants with Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) -positive advanced solid tumors were enrolled in the extended study phase.\n* Evidence of at least one measurable lesion according to RECIST 1.1 criteria, except that the dose-escalation phase is not required to be measurable, as long as it meets the assessment of disease status.\n* The main organs function well and meet the following criteria:\n\n  1. Hemoglobin (HGB) ≥80g\u002FL;\n  2. Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 \u002FL;\n  3. Platelet count (PLT) ≥100×109\u002FL, if accompanied by bone marrow invasion, platelet ≥75×109\u002FL;\n  4. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);\n  5. Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN. ALT and AST≤5×ULN if accompanied by liver metastasis;\n  6. Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥60 mL \u002Fmin (standard Cockcroft-Gault formula was applied;\n  7. Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);\n* Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Had or was currently suffering from other malignant tumors within 3 years prior to the first medication.\n* There are multiple factors that affect intravenous injection, venous blood collection diseases, or have an impact on oral drugs.\n* The adverse reactions of previous treatment failed to recover to Common Terminology Criteria for Adverse Events Version 5 (CTCAEv5.0) score ≤1.\n* Patients who had major surgical treatment, significant traumatic injury, or potential major surgery during the expected study treatment period within 4 weeks prior to initial medication, or who had long-term unhealed wounds or fractures.\n* Subjects who have had any bleeding event ≥CTCAEv5.0 level 3 within 4 weeks prior to initial dosing, or who have bleeding or clotting disease and are taking warfarin, aspirin, or other antiplatelet agglutinating agents (except maintenance doses) : Subjects with aspirin ≤100mg\u002F day, clopidogrel ≤75mg\u002F day, or with any signs of bleeding or medical history determined by the investigator to be unsuitable for enrollment.\n* Patients who experienced a hyperarterial\u002Fvenous thrombosis event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before the first administration of the drug.\n* Chronic hepatitis B active or active hepatitis C subjects. Subjects who are positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies during screening should undergo Hepatitis B Virus (HBV) DNA titer testing or HCV RNA testing.\n* Patients with active syphilis who need treatment.\n* There is a history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or active pneumonia with clinical symptoms.\n* Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.\n* Decompensated stage of cirrhosis and history of hepatic encephalopathy.\n* Subjects with clinically significant cardiovascular disease, including any of the following:\n\n  1. Participants who had acute myocardial infarction and severe\u002Funstable angina pectoris within 6 months before the start of study treatment; Or have heart failure of the New York Heart Association's heart function classification level 2 or higher;\n  2. QT interval prolongation at rest as corrected by Fridericia Formula (QTcF), QTc interval ≥450ms(male), QTc interval ≥470 ms(female);\n  3. Have a past or ongoing history of severe uncontrolled ventricular arrhythmias requiring medical treatment;\n  4. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  5. Congenital long QT syndrome, or any known history of tip torsion ventricular Torsades de Pointes (TdP);\n  6. Clinically uncontrolled hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg after standard antihypertensive therapy) and a history of hypertensive encephalopathy\u002Fhypertensive crisis.\n\nActive or uncontrolled severe infection (≥CTC AEv5.0 grade 2 infection).\n\n* Patients with renal failure requiring hemodialysis or peritoneal dialysis.\n* Have a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.\n* Subjects with (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment or who currently have non-infectious pneumonia\u002Finterstitial lung disease or have been hospitalized for any active infection or received therapeutic antibiotics in the 4 weeks prior to beginning study treatment, including but not limited to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.\n* People who have epilepsy and need treatment.\n* Urine routine indicated urine protein ≥ ++, and confirmed 24-hour urine protein quantity \\> 1.0 g.\n* Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL).\n* Tumor-related symptoms and treatment:\n\n  1. For subjects who have received chemotherapy, immunotherapy within 4 weeks prior to the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (depending on the shortest time of occurrence), the washout period is calculated from the end time of the last treatment;\n  2. Within 2 weeks before the first drug use, it has been treated with Chinese patent medicines (including compound Cantharides capsule, Kangai injection, Kanglaite capsule\u002Finjection, Aidi injection, Bruceae oil injection\u002Fcapsule, Xiaoaiping tablet\u002Finjection, hualbufatin capsule, etc.) with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;\n  3. Imaging (CT or MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding;\n  4. Uncontrolled pleuroceliac or pericardial effusion requiring repeated drainage or obvious symptoms. Subjects who are asymptomatic and have not received drainage or other treatment in the first 2 weeks of enrollment can be enrolled if imaging shows only small amounts of pleural effusion, ascites, or pericardial effusion.\n* Known allergy to study drug excipients.\n* Previous therapy with targeted ROR1 inhibitors.\n* Participants who have participated in a clinical trial of another antitumor drug (calculated as the last use of the investigational drug) within 4 weeks prior to initial administration and have used the investigational drug, or are still within 5 half-lives of the investigational drug (whichever is shorter).",{"count":456,"type":22},66,[25],"To explore the tolerability and pharmacokinetics of TQB2101 for injection in subjects with advanced malignant tumors.",[417,460,29],"Lung Cancer","2025-04-24",{"date":463,"type":34},"2025-04-29",{"date":465,"type":22},"2025-04",{"date":278,"type":22},{"name":40,"class":41},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":486,"locationsCount":487},"100530580","phase-1-clinical-trial-of-tqb2922-for-injection-in-patients-with-advanced-cancers-100530580","NCT06188624","Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers","A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers","Inclusion Criteria:\n\n* Subjects voluntarily join this study, sign the informed consent form, and have good compliance；\n* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；\n* Histologically or cytologically diagnosed with advanced cancers;\n* Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;\n* Major organs are functioning well;\n* Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.\n\nExclusion Criteria:\n\n* Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;\n* Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;\n* Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures\n* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;\n* A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;\n* Subjects with any severe and\u002For uncontrolled disease;\n* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;\n* Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;\n* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.",{"count":476,"type":22},150,[25],"This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers",[480],"Advanced Cancer",{"date":482,"type":34},"2025-04-25",{"date":484,"type":34},"2024-02-01",{"date":106,"type":22},{"name":40,"class":41},17,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100569911","phase-1-a-clinical-study-of-tqb2029-for-injection-in-subjects-with-multiple-myeloma-100569911","NCT06700395","A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma","Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n* Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.\n* Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.\n* Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria\n* There are measurable lesions present\n* The function of main organs is normal.\n* Subjects need to adopt effective methods of contraception.\n\nExclusion Criteria:\n\n* Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.\n* Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication\n* Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication\n* Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment\n* Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication\n* Subjects who have experienced arterial\u002Fvenous thrombotic event occurred within 6 months prior to the first administration\n* Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;\n* Subjects with any severe and\u002For uncontrolled disease\n* According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.",{"count":496,"type":22},136,[25],"This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.",[230],"2024-12-04",{"date":502,"type":34},"2024-12-06",{"date":504,"type":34},"2024-11-28",{"date":506,"type":22},"2028-03",{"name":40,"class":41},2,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":526,"locationsCount":527},"100550871","phase-2-the-clinical-trial-of-tqb2102-for-injection-against-human-epidermal-growth-factor-receptor-2-negative-breast-cancer-100550871","NCT06452706","The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer","The Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection in Human Epidermal Growth Factor Receptor 2 (HER2) Negative Recurrent\u002FMetastatic Breast Cancer","Inclusion Criteria:\n\n* The participants voluntarily participate in the study and sign an informed consent form.\n* Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point; Expected survival period exceeds 3 months.\n* Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of local recurrence or distant metastasis are not suitable for surgery or radiation therapy aimed at healing.\n* Sufficient tumor tissue samples must be available for HER2 evaluation by pathologists at the main research center.\n* The participants's previous treatment needs to meet the following criteria: failure after receiving at least first-line systemic chemotherapy during the recurrence \u002Fmetastasis stage (for hormone receptor positive participants, failure after receiving cyclin-dependent kinase 4 and 6 (CDK4\u002F6) inhibitors combined with endocrine therapy during the recurrence\u002Fmetastasis stage.\n* There exists disease progression or intolerance during or after the most recent treatment before enrollment.\n* According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, there should be at least one measurable lesion.\n* The main organ functions well and meets certain standards.\n* Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Concomitant diseases and medical history:\n\n  1. Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;\n  2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;\n  3. Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;\n  4. Long term unhealed wounds or fractures;\n  5. Participants who have a history of interstitial lung disease\u002Fpneumonia (non infectious) requiring steroid intervention treatment in the past, or currently have interstitial lung disease\u002Fpneumonia, or whose screening imaging suggests suspected interstitial lung disease\u002Fpneumonia and cannot be ruled out;\n  6. An arterial\u002Fvenous thrombotic event occurred within 6 months prior to the first medication use;\n  7. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;\n  8. Subjects with any severe and\u002For uncontrolled diseases. Rheumatoid arthritis with joint function activity graded as Grade IV or requiring wheelchair or bed rest.\n* Tumor related symptoms and treatment:\n\n  1. Participants who have received other anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the first medication, or who are still within the 5 half-lives of the drug (whichever is the shortest); Participants who have previously received local radiotherapy;\n  2. Received endocrine therapy or traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug directions within 2 weeks before the first drug use;\n  3. Imaging shows that the tumor has invaded important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;\n  4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts of pericardial effusion that require repeated drainage;\n  5. Known presence of cancerous meningitis or clinically active central nervous system metastasis;\n  6. Severe bone damage caused by tumor bone metastasis. Suffering from lung diseases that have been determined by the researcher to be unsuitable for participation in this study.\n* Individuals who are known to be allergic to the investigational drug or its excipients, or allergic to humanized monoclonal antibody products.\n* Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to the first medication use.\n* According to the judgment of the researchers, there are situations that seriously endanger the safety of the subjects or affect their completion of the study.",{"count":226,"type":22},[26],"This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent\u002Fmetastatic breast cancer.",[417],"2024-11-18",{"date":522,"type":34},"2024-11-19",{"date":524,"type":34},"2024-11-14",{"date":215,"type":22},{"name":40,"class":41},16,{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":548},"100567751","phase-1-a-clinical-trial-to-evaluate-the-safety-and-tolerability-of-tqb3911-tablets-in-patients-with-bcrabl-fusion-gene-positive-leukemia-100567751","NCT06672263","A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;\n* Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;\n* During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;\n* Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)\n* The main organs function well\n* Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Had or was currently suffering from other malignant tumors within 5 years before the first medication\n* Combined with active central nervous system leukemia\n* Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment\n* Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block\n* Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication\n* History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia\n* Patients with CML-CP who have achieved complete cytogenetic response (CCyR)\n* Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation\n* Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period",{"count":536,"type":22},120,[25],"Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.",[540],"Chronic Myelogenous Leukemia","2024-10-31",{"date":543,"type":34},"2024-11-04",{"date":545,"type":22},"2024-11",{"date":278,"type":22},{"name":40,"class":41},5,""]