[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Convalife (Shanghai) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":206},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,78,101,124,152,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100639428","phase-1-clinical-study-of-cvl006-combination-with-9mw2821-100639428",false,"NCT07615660","Clinical Study of CVL006 Combination With 9MW2821","Phase Ib\u002FII Clinical Study of CVL006 Combination With 9MW2821 in Advanced Solid Tumors","CVL006-T1003","Inclusion Criteria:\n\n* Age: 18-75 years old (inclusive), no restriction on gender.\n* Patients with histologically or cytologically confirmed advanced solid tumors. Cohort A: Squamous cell carcinoma of the head and neck; the primary tumor must arise from the oral cavity, oropharynx, hypopharynx or larynx, excluding nasopharyngeal tumors, salivary gland tumors and\u002For parotid gland tumors.\n* For Phase Ib participants: Advanced solid tumors with failure of prior standard therapy. For Phase II part, Cohort A: Recurrent or metastatic disease not curable by local therapy. Participants must have no prior systemic therapy, unless the prior systemic therapy was completed more than 6 months ago as adjuvant or neoadjuvant treatment. Participants who received prior PD-1\u002FPD-L1 inhibitors in curative therapy are eligible if at least 12 months have elapsed since the last dose of anti-PD-L1 agent. Cohort B: No prior systemic therapy for locally advanced or metastatic disease. For patients who received adjuvant\u002Fneoadjuvant therapy or curative chemoradiotherapy, disease progression within 6 months after the last treatment is regarded as first-line setting.\n* For Phase II: PD-L1 Combined Positive Score (CPS) ≥ 1 confirmed by local or central immunohistochemistry (IHC). If no PD-L1 testing result is available, participants shall submit archived or fresh tumor tissue samples during screening for central laboratory testing of programmed death ligand-1 (PD-L1) and Nectin4. The central PD-L1 testing result must be obtained prior to enrollment. Participants with known PD-L1 results confirming CPS ≥ 1 shall submit archived or fresh tissue samples for exploratory analysis within 5 days after enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1.\n* Estimated survival time ≥ 3 months.\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Adequate bone marrow and organ function (no blood components and\u002For hematopoietic growth factors administered within 14 days prior to the initiation of study treatment):\n\nHemoglobin (HB) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL; Platelet (PLT) ≥ 90×10⁹\u002FL; Total bilirubin \\\u003C 1.5×ULN (for participants with confirmed Gilbert's syndrome, total bilirubin ≤ 3×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN; Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula); nternational Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN;\n\n* Urinalysis protein ≤ 1+; or if urine protein ≥ 2+, 24-hour urine protein \\\u003C 1 g.\n* Females of childbearing potential must agree to abstain from heterosexual intercourse or use highly effective contraceptive methods from the signing of informed consent until at least 6 months after the last dose of study drug. Serum HCG test must be negative within 7 days prior to study treatment initiation, and participants must be non-lactating. (A positive serum pregnancy test requires exclusion of pregnancy, and enrollment can only be confirmed after discussion with the sponsor.)\n* Male patients with female partners of childbearing potential must agree to abstain from intercourse or use highly effective contraceptive methods from the signing of informed consent until at least 6 months after the last dose of study drug. Male participants must also agree not to donate sperm during the same period.\n* Participants voluntarily join the study, sign the informed consent form, and have good treatment compliance.\n\nExclusion Criteria:\n\n* 1\\. Participants with active central nervous system (CNS) metastases are excluded. Participants with previously treated CNS metastases are eligible only if all of the following criteria are met: The CNS metastases have been clinically stable for ≥ 6 weeks prior to screening; If steroid therapy is required for CNS metastases, participants are on a stable steroid dose equivalent to ≤ 20 mg\u002Fday prednisone for at least 2 weeks; Baseline imaging shows no evidence of new or enlarging brain metastases; Participants have no leptomeningeal disease.\n* Participants with other malignant tumors within 5 years prior to the first dose of study drug, except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.\n* Participants with tumors judged by the Investigator to be prone to bleeding, including those with imaging evidence of tumor invasion into or encasement of major blood vessels on screening imaging.\n* Participants with prior exposure to VEGF\u002FPD-1 (PD-L1) bispecific antibodies or Nectin4-targeted therapy.\n* Participants with severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\nSevere cardiac rhythm or conduction abnormalities within 6 months prior to the first study drug dose, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block; History of acute coronary syndrome, congestive heart failure (New York Heart Association \\[NYHA\\] functional class ≥ II), or aortic dissection within 6 months prior to the first dose; History of arteriovenous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, stroke), deep vein thrombosis and pulmonary embolism; Left ventricular ejection fraction (LVEF) \\\u003C 50% within 28 days prior to the first dose; Mean QTcF interval averaged from 3 baseline 12-lead (or more) electrocardiograms at rest: QTcF \\> 470 ms (female) or QTcF \\> 450 ms (male).\n\n* Participants with persistent clinically significant toxicities (≥ Grade 2, alopecia excluded) related to prior therapy (including systemic therapy, radiotherapy or surgery). Participants with persistent ≥ Grade 2 immune-related hypothyroidism or panhypopituitarism are excluded. Participants with persistent immune-related colitis, uveitis, myocarditis, pneumonitis, or other immune-related adverse events requiring high-dose steroid therapy (\\> 20 mg\u002Fday prednisone or equivalent) are excluded. Participants with well-controlled ≤ Grade 2 immune-related hypothyroidism or panhypopituitarism on stable hormone replacement therapy (if applicable) are eligible. Participants with ≥ Grade 2 sensory or motor neuropathy are excluded.\n* Participants with active autoimmune diseases or a history of autoimmune diseases prone to recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis), excluding clinically stable autoimmune thyroid disease and type 1 diabetes mellitus.\n* Participants who have undergone major surgery within 4 weeks prior to the first study drug dose; received radiotherapy, chemotherapy, biological agents, investigational drugs, and\u002For immunotherapy for antitumor purposes within 2 weeks prior to the first dose; or received traditional Chinese medicine with antitumor indications within 2 weeks prior to the first dose.\n* Participants with a history of steroid-dependent (non-infectious) pneumonitis\u002Finterstitial lung disease or currently suffering from such diseases; history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT during screening.\n* Participants judged by the Investigator to have an expected survival of less than 3 months and\u002For rapidly progressive disease (e.g., tumor bleeding, uncontrolled tumor pain).\n* Participants with a history of esophageal gastric varices, severe peptic ulcer, unhealed wounds, abdominal fistula, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose; history of gastrointestinal perforation and\u002For fistula, severe gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive intestinal resection (partial colectomy or extensive small bowel resection) within 6 months prior to the first dose.\n* Participants with a history of immunodeficiency including positive HIV test; active hepatitis B infection (HBV DNA above the upper limit of normal of the local study center) or hepatitis C infection (anti-HCV positive and HCV RNA above the lower limit of quantification of the assay).\n* Participants with active pulmonary tuberculosis infection within 1 year prior to enrollment confirmed by medical history or CT examination; or those with a history of active pulmonary tuberculosis infection more than 1 year ago without standard anti-tuberculosis treatment.\n* Participants with a history of bleeding tendency or coagulation disorders and\u002For clinically significant bleeding symptoms or risks within 4 weeks prior to the first dose, including but not limited to:\n* a. Gastrointestinal bleeding;\n* b. Hemoptysis (coughing up ≥ 15 mL fresh blood or blood clots);\n* c. Epistaxis;\n* d. Receiving therapeutic anticoagulation prior to the first dose.\n* Participants with a history of hypertensive crisis or hypertensive encephalopathy; persistent hypertension within 1 month prior to the first dose with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite oral antihypertensive treatment.\n* Participants with uncontrolled diabetes within 3 months prior to the first study treatment dose, defined as: Glycated hemoglobin (HbA1c) ≥ 8%; or HbA1c between 7% and \\\u003C 8% accompanied by unexplained diabetes-related symptoms (polyuria or polydipsia).\n* Participants with active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis or chronic diarrhea).\n* Participants with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Participants who have received live attenuated vaccines within 30 days prior to the first dose or plan to receive live vaccines during the study period.\n* Participants with known active keratitis or corneal ulcer are excluded; participants with superficial punctate keratitis under adequate treatment are allowed to be enrolled.\n* Participants requiring use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first study dose and during the study period (concomitant use of strong CYP3A4 inhibitors or inducers is prohibited; representative drugs are listed in the appendix).\n* Participants with any other conditions judged by the Investigator that may interfere with study results or lead to premature study termination, such as alcohol abuse, drug abuse, uncontrolled severe diseases (including psychiatric disorders) requiring combined medication, significantly abnormal laboratory parameters, family\u002Fsocial factors, or any other conditions that may compromise participant safety or affect study data collection.","ALL","18 Years","75 Years",{"count":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is a multi-center, open-label, dose-escalation and dose-optimized phase I\u002FII clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW821 patients with advanced solid tumors.",[29],"Advanced Solid Tumor",[29,31,32,33],"Combination medication","DLT","RP2D","NOT_YET_RECRUITING","2026-05-28",{"date":37,"type":38},"2026-05-29","ACTUAL",{"date":40,"type":22},"2026-05-15",{"date":42,"type":22},"2029-04-30",{"name":44,"class":45},"Convalife (Shanghai) Co., Ltd.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100627239","phase-2-a-single-arm-open-label-multicenter-phase-ibii-clinical-trial-of-cvl237-tablets-in-combination-with-serplulimab-injection-for-the-treatment-of-advanced-solid-tumors-with-pten-loss-or-low-expression-100627239","NCT07446049","A Single-arm, Open-label, Multicenter, Phase Ib\u002FII Clinical Trial of CVL237 Tablets in Combination With Serplulimab Injection for the Treatment of Advanced Solid Tumors With PTEN Loss or Low Expression","Inclusion Criteria:\n\n1. Aged 18 to 75 years (inclusive of both endpoints), regardless of gender；\n2. Patients with locally advanced or metastatic solid tumors (gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, lung cancer, breast cancer, and other tumor types) confirmed by histology or cytology, and with PTEN loss or low expression. Patients who have experienced disease progression after standard treatment or have intolerable toxicities from prior therapies, or for whom no standard treatment is available, as determined by the investigator. For breast cancer participants, PTEN low expression is limited to those who have relapsed or metastasized after prior treatment with trastuzumab and\u002For CDK4\u002F6 inhibitors;\n3. PTEN loss or low expression confirmed by IHC staining. The definition of PTEN loss or low expression is referenced as follows: Using a dual-scoring method, score the percentage of positive cells: 0% = 0 points; 1-25% = 1 point; 26-50% = 2 points; 51-75% = 3 points; ≥76% = 4 points. Score the staining intensity: no staining = 0 points; light brownish-yellow = 1 point; brownish-yellow = 2 points; brown = 3 points. Add the scores from the two categories. A total score of 0-2 is classified as \"A,\" 3-6 as \"B,\" and ≥7 as \"C.\" \"A\" indicates negative expression and is defined as PTEN loss; \"B\" indicates PTEN positive with low expression; \"C\" indicates PTEN positive with high expression;\n4. ECOG Performance Status (PS) of 0-1;\n5. Life expectancy of ≥3 months;\n6. Presence of at least one measurable lesion according to RECIST v1.1 criteria;\n7. Sufficient bone marrow and organ function levels (no use of blood products and\u002For hematopoietic growth factors within 14 days prior to the start of study treatment):\n8. Fertile eligible study participants (both male and female) must agree to use a reliable method of contraception (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for at least 6 months after the last dose of study drug; Women of childbearing potential must not breastfeed. Women of childbearing potential must also have a negative pregnancy test prior to the first dose of study drug;\n9. Voluntarily participating in this clinical trial, understanding the study procedures, and being able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Surgery or Trauma: Undergone major organ surgery or experienced significant trauma within 4 weeks before the first administration of the study drug, or requires elective surgery during the trial period; undergone core needle biopsy or other minor surgeries (excluding central venous catheterization or port-a-cath implantation) within 7 days before the first dose;\n2. Insufficient Washout Period for Prior Anti-tumor Treatments;\n3. Inability to Swallow, Chronic Diarrhea, or Bowel Obstruction: Presence of factors that may affect the intake and absorption of the study drug;\n4. Unhealed Wounds or Interventions: Unhealed wounds, abdominal fistulas, gastrointestinal stent placement, or extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before the first dose;\n5. Uncontrolled Effusions: Presence of uncontrolled pleural effusion, ascites, or pericardial effusion;\n6. Concurrent Use of Certain Medications: Currently using medications that are substrates of OATP1B1 and OATP1B3, CYP3A4\u002F5 substrates, moderate or strong CYP3A4\u002F5 inhibitors, or strong CYP3A4\u002F5 inducers, and cannot discontinue or switch to alternative treatments before starting the study treatment;\n7. Central Nervous System (CNS) Metastases or Meningitis: Participants with untreated or active CNS metastases (e.g., brain edema, requiring steroid intervention, or progressive brain metastases) and\u002For carcinomatous meningitis. However, participants with CNS metastases who have received adequate local treatment (surgery or radiotherapy) and have no progression on imaging at screening after completion of local treatment may be eligible. Participants must have stable neurological symptoms for at least 2 weeks before the first dose and not require corticosteroid treatment;\n8. History of Severe Allergic Reactions: Known history of severe allergic reactions to multiple medications;\n9. Immune-related Adverse Events (irAEs): Participants who experienced ≥ Grade 3 irAEs or ≥ Grade 2 immune-related myocarditis during prior immunotherapy are not eligible;\n10. Active or Potentially Recurrent Autoimmune Diseases: Participants with any active or history of autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis), except for clinically stable autoimmune thyroid disease or Type I diabetes;\n11. Systemic Corticosteroid or Immunosuppressive Therapy: Participants who received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug. Exceptions include: Use of topical, ocular, intra-articular, nasal, or inhaled corticosteroids; Short-term (≤7 days) use of corticosteroids (≤10 mg prednisone equivalent) for prophylaxis or treatment of non-autoimmune allergic conditions (e.g., preventing contrast agent allergy);\n12. Interstitial Pneumonia or Severe Pulmonary Diseases: Known or suspected interstitial pneumonia; other severe pulmonary diseases significantly affecting respiratory function within 3 months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans; non-infectious pulmonary inflammation requiring steroid treatment;\n13. Infectious Diseases: Positive HIV test; participants with active chronic hepatitis B or active hepatitis C. Carriers of hepatitis B virus, stable hepatitis B after treatment (HBV DNA copy number below the detection limit of the testing center or deemed stable by the investigator), and cured hepatitis C patients (HCV RNA test result below the detection limit of the testing center) may be eligible;\n14. Unresolved Adverse Events from Prior Anti-tumor Treatment: Adverse events from prior anti-tumor treatment that have not resolved to ≤ Grade 1 (CTCAE 5.0), except for alopecia or other toxicities deemed non-threatening by the investigator;\n15. Severe Infections: Severe infection within 4 weeks before starting study treatment, including but not limited to bacteremia; active infection within 2 weeks before starting treatment requiring intravenous antibiotics;\n16. Active Tuberculosis: History or CT evidence of active pulmonary tuberculosis within 1 year before enrollment;\n17. Serious Cardiovascular or Cerebrovascular Events: Acute coronary syndrome, congestive heart failure (NYHA functional class ≥ II), aortic dissection, cerebral hemorrhage, stroke, or deep vein thrombosis within 6 months before the first dose;\n18. Vaccination: Received live or attenuated vaccines within 30 days before the first dose of study drug, or planned to receive live or attenuated vaccines during the trial;\n19. Other Primary Malignancies: History of other primary malignancies within 5 years before the first dose, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc;\n20. History of Allogeneic Organ or Hematopoietic Stem Cell Transplantation: Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation；\n21. Other Conditions Deemed Ineligible by the Investigator: Such as alcohol or drug abuse, history of significant neurological or psychiatric disorders (e.g., epilepsy, dementia), or poor compliance.",{"count":53,"type":22},180,[26],"This is a single-arm, open-label, multicenter, Phase Ib\u002FII clinical trial of CVL237 tablets in combination with serplulimab injection for the treatment of advanced solid tumors with PTEN loss or low expression",[57,58],"Locally Advanced or Metastatic Solid Tumors","PTEN Loss or Low Expression",[60,61,62,63,64,65,66,67,68,69],"CVL237","Patients with PTEN loss or low expression","Patients with locally advanced or metastatic solid tumors","gastric cancer","endometrial cancer","cervical cancer","ovarian cancer","lung cancer","breast cancer","other tumor types","2026-02-25",{"date":72,"type":38},"2026-03-03",{"date":74,"type":22},"2026-05-01",{"date":76,"type":22},"2028-04-08",{"name":44,"class":45},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100605087","phase-1-cvl006-combination-therapy-in-advanced-solid-tumors-100605087","NCT07157956","CVL006 Combination Therapy in Advanced Solid Tumors","Phase I\u002FII Clinical Study of CVL006 Combination Therapy in Advanced Solid Tumors","CVL006-T1002","Inclusion Criteria:\n\n1. Age: 18 to 75 years old (including both ends), gender not limited;\n2. Stage I Arm1.1, Arm1.2, Arm1.3 and Arm1.4: Locally advanced, recurrent or metastatic solid tumors confirmed by histology or cytology, with previous treatment failure.\n3. Phase II Arm2.1, Arm2.2, Arm2.5 and Arm2.7: For NSCLC Arm2.1: Non-squamous, wild-type NSCLC Arm2.2: EGFRm nsqNSCLC Arm2.3: Malignant pleural mesothelioma Arm2.4: triple-negative breast cancer Arm2.5: EGFRm nsqNSCLC Arm2.6: breast cancer Arm2.7: NSCLC Arm2.8: adenocarcinoma of the stomach or gastroesophageal junction Arm2.9: urothelial carcinoma\n4. All subjects must provide tumor tissue samples for PD-L1 testing: Tumor tissue samples should preferably be newly obtained tumor tissues. For subjects who cannot provide newly obtained tissues, tumor tissue samples archived within 3 years prior to the first study treatment can be provided. The sample type should be neutral formalin-fixed and paraffin-embedded \\[FFPE\\] tissue wax blocks or at least 6 unstained tumor tissue sections. If the number is less than 6 pieces, it is necessary to negotiate with the sponsor and only allow enrollment after obtaining consent.\n5. ECOG overall performance status (PS) 0-1 point;\n6. Predicted survival period ≥ 3 months;\n7. According to the efficacy evaluation criteria for solid tumors (RECISTv 1.1), there is at least one measurable lesion;\n8. Have sufficient bone marrow and organ function (no blood components and\u002For cell growth factors have been used within 14 days prior to the start of the study treatment) :\n\n   Hemoglobin (HB) ≥ 90 g\u002FL;\n\n   • Neutrophil count (ANC) ≥1.5×109\u002FL;\n\n   Platelet count (PLT) ≥ 90×109\u002FL;\n\n   • Total bilirubin \\\u003C 1.5×ULN (for subjects diagnosed with Gilbert syndrome, total bilirubin ≤ 3×ULN);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN (for patients with liver metastasis, ALT and\u002For AST≤ 5×ULN);\n   * Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula);\n   * International normalized ratio (INR) and activated partial thromboplastin (APTT) time ≤1.5×ULN;\n   * Qualitative urine protein ≤1+; Or the qualitative urine protein is ≥2+, and the 24-hour urine protein should be less than 1g\n9. Fertile women must agree to abstain from sexual activity (avoiding heterosexual intercourse) or use effective contraceptive methods for at least six months from the date of signing the informed consent form until the last administration of the study drug. Moreover, the blood HCG test must be negative within 7 days before the start of the study treatment, and the patient must not be in the lactation period (if the serum pregnancy test is positive, pregnancy must be excluded and confirmed after discussion with the sponsor for enrollment).\n10. For male patients whose partners are women of childbearing age, they must agree to abstain from sexual activity for at least six months from the date of signing the informed consent form until the last administration of the study drug, or use effective contraceptive methods. Male patients must also agree not to donate sperm during the same period of time.\n11. The patients voluntarily joined this study, signed the informed consent form and had good compliance.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or those currently having meningeal metastasis.\n2. Patients with other malignant tumors, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, papillary thyroid carcinoma after radical resection, or those with other malignant tumors, must have at least a 3-year tumor-free period.\n3. For those whose tumor lesions are judged by researchers to have a bleeding tendency, such as those whose imaging examinations during the screening period show that the subjects have: imaging evidence of tumor invasion or encirclement of large blood vessels;\n4. Exclude subjects who have previously used VEGF\u002FPD-1 (PD-L1) bispecific antibodies; Subjects who have previously received targeted therapy with TROP2, HER2 or Nectin-4, ADC, or any study drugs containing MMAE and whose treatment duration is less than 6 months should also be excluded. Subjects who had previously used bevacizumab were excluded.\n5. Previously used immune checkpoint agonist therapy (such as CD137 agonists), anti-CD73 inhibitors, immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), and immune cell therapy (such as CAR-T) And other treatments targeting the tumor immune mechanism are not allowed to be enrolled.\n6. It is known that there is an allergic reaction to CVL006, SKB264, T-DXd, Enfortumab Vedotin, pemetrexel or platinum-based or any excipient component of the study drug (including histidine, trehalose and polysorbide 20), or there is a history of severe allergic reaction to other monoclonal antibodies;\n7. Have serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   1. Severe cardiac rhythm or conduction abnormalities within 6 months prior to the first use of the study drug, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.\n   2. Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA) cardiac function classification ≥ grade II), and aortic dissection occurred within 6 months prior to the first use of the study drug;\n   3. There have been arteriovenous thrombotic events such as cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, stroke), deep vein thrombosis and pulmonary embolism, etc. within 6 months before the first use of the study drug;\n   4. The left ventricular ejection fraction (LVEF) was less than 50% within 28 days prior to the first use of the study drug;\n   5. The mean value of QTcF obtained from three electrocardiogram examinations at baseline 12 (or above) in the resting state, with QTcF\\> 470 ms (for females) or QTcF\\> 450 ms (for males);\n8. There is uncontrollable pleural effusion, peritoneal effusion or pericardial effusion;\n9. Patients with known or suspected interstitial pneumonia; Within three months prior to the first administration, there are other severe pulmonary diseases that seriously affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobliterative bronchiolitis; Non-infectious pulmonary inflammation that currently requires steroid treatment;\n10. Patients who have previously received immunotherapy and have developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;\n11. Patients with active or previous autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) are excluded, except for those with clinically stable autoimmune thyroid diseases and type 1 diabetes.\n12. Had received systemic glucocorticoids (prednisone \\> 10mg\u002F day or equivalent doses of similar drugs) or other immunosuppressants within 14 days prior to the first use of the study drug; Except for the following situations: treatment with topical, ocular, intra-articular, intranasal and inhaled glucocorticoids; Short-term use of glucocorticoids for preventive treatment (such as to prevent contrast agent allergy).\n13. Within 6 months prior to the first administration, there was a history of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, abdominal abscesses or acute gastrointestinal bleeding; A history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first administration, severe gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), and extensive intestinal resection (partial colectomy or extensive small intestine resection);\n14. Arm2.3 Exclude primary peritoneal, pericardial and testicular sheath mesothelioma.\n15. Patients with Arm2.9 urothelial carcinoma, except for those with eye diseases or symptoms that may increase the risk of corneal epithelial damage before the first treatment with the study drug and are not suitable for participation in this study; Patients with a history of grade ≥2 peripheral neuropathy are excluded. Patients with baseline HbA1c≥8% were excluded.\n16. There was a severe infection within 4 weeks before the start of the study treatment, including but not limited to bacteremia, severe pneumonia or other serious infectious complications that require hospitalization, etc. There is an active infection of CTCAE grade ≥ 2 that requires intravenous anti-infective treatment within 2 weeks before the first administration.\n17. Have a history of immune deficiency, including a positive HIV test; There is active hepatitis B (HBV DNA higher than the upper limit of the normal value of the testing center) or hepatitis C (anti-HCV positive and HCV RNA higher than the detection limit of the analytical method);\n18. Those who were found to have had active pulmonary tuberculosis infection within one year prior to enrollment through medical history or CT examination, or those with a history of active pulmonary tuberculosis infection more than one year ago but have not received regular treatment;\n\n19\\. The adverse reactions of previous anti-tumor treatment have not yet recovered to CTCAE v 5.0 grade evaluation ≤1 (alopecia, grade 2 peripheral neurotoxicity (Arm2.9 requirement ≤1), except for the numerical requirements in the inclusion criteria or other situations determined by the investigator that do not affect the treatment of the study drug);\n\n20\\) Those who have received chemotherapy within 3 weeks before the first use of the study drug, or have received anti-tumor treatments such as macromolecular biological therapy (including immunotherapy) or other unmarketed clinical research drugs within 4 weeks before the first use; Excluding the following items:\n\nFor oral fluorouracil and small molecule targeted drugs, it is within two weeks before the first use of the study drug or within five half-lives of the drug, whichever is shorter.\n\nb. For traditional Chinese medicines with anti-tumor indications, it is two weeks before the first use of the study drug;\n\nc. Radical radiotherapy is 4 weeks before the first use of the study drug, and palliative radiotherapy is 2 weeks before the first use of the study drug.\n\n21\\) Having undergone major organ surgery, experienced significant trauma, or required elective surgery during the trial period within 4 weeks prior to the first use of the study drug; Perform a coarse needle biopsy or other minor surgery (excluding central venous intubation and port implantation) within 7 days before the first administration of the drug;\n\n22\\. There is a history of bleeding tendency or coagulation disorder and\u002For clinically significant bleeding symptoms or risks within 4 weeks prior to the first administration, including but not limited to: a. Gastrointestinal bleeding b. Hemoptysis (coughing up ≥15ml of fresh blood or blood clots); c. Epistaxis\u002Fnosebleeds d. Receive therapeutic anticoagulant therapy before the first administration;\n\n23\\) A history of hypertensive crisis or hypertensive encephalopathy in the past; There was hypertension within one month before the first administration and the systolic blood pressure was ≥150mmHg or the diastolic blood pressure was ≥100mmHg after oral antihypertensive drugs.\n\n24\\) Active or with a previous history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis or chronic diarrhea);\n\n25\\) There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n\n26\\) Those who need to use strong suppressors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first administration and during the study period (the use of strong suppressors or inducers of CYP3A4 is not allowed. The representative drugs of strong suppressors or inducers of CYP3A4 are listed in the attachment);\n\n27\\) Receive a live virus vaccine 30 days before the first administration, or plan to receive a live vaccine during the study period;\n\n28\\) As determined by the researchers, the subjects have other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental disorders) requiring concurrent treatment, severely abnormal laboratory test values, family or social factors, and other circumstances that may affect the safety of the subjects or the collection of experimental data, etc.",{"count":87,"type":22},318,[25,26],"This study is a multi-center, open-label, dose-escalation and dose-optimized phase I\u002FII clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with pemetrexed + carboplatin\u002FSKB264\u002F DS-8201a\u002F Enfortumab Vedotin in patients with advanced solid tumors.",[29],[29,32,33],"2025-08-28",{"date":94,"type":38},"2025-09-05",{"date":96,"type":22},"2025-09-10",{"date":98,"type":22},"2028-12-30",{"name":44,"class":45},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100563857","phase-1-clinical-study-of-cvl006-injection-in-advanced-solid-tumors-100563857","NCT06621615","Clinical Study of CVL006 Injection in Advanced Solid Tumors","An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of CVL006 Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n\\- Participants must meet all of the following inclusion criteria in order to be enrolled in this study\n\n1. Age: 18\\~75 years old (including both ends), gender not limited;\n2. Dose escalation and dose expansion stage: For patients with advanced malignant solid tumors confirmed by histology or cytology, if standard treatment has failed, or if there is no standard treatment plan, or if standard treatment is not applicable at this stage;\n\n   Efficacy expansion stage: Requirements for different types of tumors are as follows:\n\n   Queue 1: Non small cell lung cancer (NSCLC) Locally advanced, recurrent, or metastatic NSCLC confirmed by histology or cytology, except for subjects known to have other driver genes (including sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600E mutations, NTRK fusion, RET fusion, etc.); The subject received platinum based treatment on the first line, but did not receive PD-1\u002FPD-L1 inhibitor treatment and had previous treatment failures; Or it may be determined by researchers that first-line platinum based dual therapy is intolerant, but PD-L1 TPS is ≥ 1%; Queue 2: Malignant Solid Tumors of MSI-H\u002FdMMR Subjects with locally advanced, recurrent, or metastatic MSI-H\u002FdMMR malignant solid tumors confirmed by histology or cytology, such as colorectal cancer, head and neck squamous cell carcinoma, etc., will be discussed and determined by the researchers and sponsors based on safety, PK, and efficacy results.\n\n   Queue 3: Based on previous data, determine the tumor type with good therapeutic effect or recommended by the researcher (such as TMB-H) Subjects with locally advanced, recurrent, or metastatic TMB-H malignant solid tumors confirmed by histology or cytology as inoperable will be discussed and determined by the researchers and the sponsor based on safety, PK, and efficacy results.\n3. All subjects are required to provide tumor tissue samples for PD-L1 testing: tumor tissue samples should preferably be newly obtained. For subjects who cannot provide newly obtained tissue, they can provide tumor tissue samples archived within 3 years before the first study treatment. The sample type should be neutral formalin fixed, paraffin embedded \\[FFPE\\] tissue blocks or at least 6 unstained tumor tissue sections; If there are less than 6 pieces, it is necessary to consult with the sponsor and obtain their agreement before being allowed to be included in the group;\n4. ECOG performance status (PS) score 0-1 points;\n5. Predicted survival period ≥ 3 months\n6. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), having at least one measurable lesion;\n7. Having sufficient bone marrow and organ function (without using any blood components and\u002For cell growth factors within 14 days prior to starting the study treatment):\n\n   Hemoglobin (HB) ≥ 90 g\u002FL; Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 90 × 109\u002FL； Total bilirubin\\\u003C1.5×ULN (for subjects diagnosed with Gilbert syndrome, total bilirubin≤3×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (in patients with liver metastases, ALT and\u002For AST ≤5×ULN)； International normalized ratio (INR) and activated partial thromboplastin (APTT) time≤1.5×ULN; Qualitative analysis of urinary protein≤1+; Or urine protein qualitative≥2+, requiring 24-hour urine protein\\\u003C1g\n8. Women with fertility must agree to abstain from sexual activity (avoid heterosexual intercourse) or use effective contraception methods for at least 6 months from the time of signing the informed consent form until the last administration of the study drug. And within 7 days before starting the study treatment, the blood HCG test must be negative and must be non lactating (if the serum pregnancy test is positive, pregnancy must be ruled out and confirmed with the sponsor before inclusion);\n9. For male patients whose partners are women of childbearing age, they must agree to abstain from sexual activity for at least 6 months from the signing of the informed consent form until the last administration of the study drug, or to use effective contraception methods. Male patients must also agree not to donate sperm during the same time period;\n10. The patient voluntarily joined this study, signed an informed consent form, and showed good compliance.\n\nExclusion Criteria:\n\n\\-\n\nSubjects with any of the following conditions will not be included in this study:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.\n\n   -For CNS metastatic subjects, if the CNS tumor has received sufficient local treatment (surgery or radiotherapy); From the end of local treatment to the screening period, no progress was found on imaging examinations; The neurological symptoms of the subjects can be stable for at least 2 weeks before the first medication and do not require glucocorticoid treatment; You can participate in the research;\n2. Patients with other malignant tumors within the five years prior to the first use of the investigational drug, except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery;\n3. If the researcher determines that the tumor lesion has a tendency to bleed, and the screening imaging examination shows that the subject has imaging evidence of tumor invasion or wrapping around large blood vessels;\n4. Subjects who have previously used VEGF\u002FPD-1 (PD-L1) bispecific antibodies;\n5. Have serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   1. Severe cardiac rhythm or conduction abnormalities within 6 months prior to the first use of the investigational drug, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;\n   2. Within 6 months prior to the first use of the investigational drug, acute coronary syndrome, congestive heart failure (NYHA functional class ≥ II), and aortic dissection occurred;\n   3. Within the first 6 months prior to the use of the investigational drug, there have been incidents of arteriovenous thrombosis, such as cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, stroke), deep vein thrombosis, and pulmonary embolism;\n   4. Left ventricular ejection fraction (LVEF)\\\u003C50% within 28 days prior to the first use of the investigational drug;\n   5. In a resting state, the mean QTcF obtained from three baseline 12 (or more) lead electrocardiograms is greater than 470 ms for females or greater than 450 ms for males;\n6. There is uncontrollable pleural effusion, abdominal effusion, or pericardial effusion;\n7. Patients known or suspected to have interstitial pneumonia; Within three months prior to the first administration, other severe lung diseases that severely affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans; Non infectious pulmonary inflammation currently requiring steroid treatment;\n8. Patients who have received immunotherapy in the past and have experienced ≥ grade 3 irAE or ≥ grade 2 immune related myocarditis;\n9. Patients with active or ever suffered from autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except patients with clinically stable autoimmune thyroid disease and type I diabetes.\n10. Have received systemic corticosteroid (prednisone\\>10mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive therapy within 14 days prior to the first use of the study drug; Excluding the following situations: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; Short term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies).\n11. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to the first administration; History of gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), and extensive intestinal resection (partial colectomy or extensive small bowel resection) within 6 months prior to the first administration;\n12. Severe infections, including but not limited to bacteremia, severe pneumonia, or other serious infection complications requiring hospitalization, occurred within 4 weeks prior to the start of the study treatment; Within 2 weeks prior to the first administration, there is an active infection with CTCAE ≥ 2 that requires intravenous anti infective treatment;\n13. History of immunodeficiency, including HIV testing positive; Presence of active hepatitis B (HBV DNA higher than the upper limit of normal values in the research center) or hepatitis C (anti HCV positive and HCV RNA higher than the lower limit of analysis method detection);\n14. Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;\n15. Adverse reactions to previous anti-tumor treatments have not yet recovered to a CTCAE v 5.0 rating of ≤ 1 (except for hair loss, grade 2 peripheral neurotoxicity, meeting the numerical requirements of the inclusion criteria, or other situations determined by the researcher to not affect the study drug treatment);\n16. Have received chemotherapy within 3 weeks prior to the first use of the investigational drug, and have received large molecule biologic therapy (including immunotherapy) or other non marketed clinical investigational drug therapy or other anti-tumor treatments within 4 weeks prior to the first use of the investigational drug; Excluding the following:\n\n    1. Oral fluorouracil and small molecule targeted drugs should be administered within 2 weeks before the first use of the investigational drug or within 5 half lives of the drug (whichever is longer);\n    2. Traditional Chinese medicine with anti-tumor indications should be used 2 weeks before the first use of the investigational drug;\n    3. Radical radiotherapy is administered 4 weeks before the first use of the study drug, while palliative radiotherapy is administered 2 weeks before the first use of the study drug; During the efficacy expansion phase, those who have been treated with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as PD-1, PD-L1, etc.) within 6 months prior to the first use of the investigational drug are not allowed to be enrolled.\n\n18\\. Have undergone major organ surgery within 4 weeks prior to the first use of the investigational drug, have experienced significant trauma, or require elective surgery during the trial period; Perform coarse needle aspiration biopsy or other minor surgery within 7 days before the first medication (excluding central venous catheterization and infusion port implantation); 19. Within 4 weeks before the first administration, there is a history of bleeding tendency or coagulation disorders and\u002For clinically significant bleeding symptoms or risks, including but not limited to: a Gastrointestinal bleeding; b. Hemoptysis (coughing up ≥ 15ml of fresh blood or blood clots); c. Nasal bleeding\u002Fepistaxis; d. Receive therapeutic anticoagulant therapy before the first administration; 20. History of hypertensive crisis or hypertensive encephalopathy in the past; Within one month before the first administration, there is hypertension and the systolic blood pressure is ≥ 150mmHg or diastolic blood pressure is ≥ 100mmHg after oral antihypertensive medication; 21. Active or previous history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); 22. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 23. Known to have a history of severe allergic reactions to multiple medications; 24. Receive live virus vaccine 30 days before the first administration, or plan to receive live vaccine during the study period; According to the researchers' assessment, there are other factors that may affect the research results or force the termination of this study, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concomitant treatment, severe abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of experimental data.",{"count":109,"type":22},120,[25],"Evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; Observe the dose limiting toxicity (DLT) of CVL006 monotherapy in patients with advanced solid tumors, evaluate the maximum tolerated dose (MTD), and recommend the dosage for phase II clinical trials (RP2D).",[29],[114,32,115,33],"Late stage solid tumor","MTD","2024-09-28",{"date":118,"type":38},"2024-10-01",{"date":120,"type":22},"2024-11-20",{"date":122,"type":22},"2028-11-20",{"name":44,"class":45},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100555978","phase-2-neratinib-tablets-monotherapy-for-advanced-solid-tumors-with-her2-mutations-100555978","NCT06519110","Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations","A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets Monotherapy in the Treatment of Advanced Solid Tumors With HER2 Mutations","CVL009-C2001","Inclusion Criteria:\n\n* 1.Age is 18 years or older, and the patient can be male or female;\n* 2.Histologically or cytologically confirmed advanced non-small cell lung cancer, cholangiocarcinoma, cervical cancer, and salivary gland cancer patients; those who have failed to respond to ≤2 lines of standard treatment (disease progression after treatment or intolerable toxic side effects of treatment), or have no standard treatment options, or are unable to receive standard treatment;\n* 3.Previously underwent second-generation sequencing testing with evidence of HER2 mutation, otherwise, the patient must provide sufficient tissue samples for second-generation sequencing testing in the study's central laboratory, with tissue samples being the primary source; if tissue slices or samples that meet the requirements cannot be obtained, blood samples may be provided for testing.\n* 4.According to the RECIST v1.1 criteria (see Appendix 1), there must be at least one measurable lesion; if the only lesion is one that has previously received local treatment (such as radiotherapy, ablation, interventional treatment, etc.), there must be clear radiological evidence of disease progression;\n* 5.Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;\n* 6.Predicted survival is 3 months or more;\n* 7.Bone marrow reserve must meet the following laboratory value criteria: Absolute neutrophil count (ANC) is ≥1.5 × 10\\^9\u002FL; Platelet count (PLT) is ≥90 × 10\\^9\u002FL; Hemoglobin (Hb) is ≥90 g\u002FL; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) are ≤2.5 × ULN (the upper limit of the normal range); if liver metastasis is present, it should be ≤5 × ULN; Total bilirubin (TBIL) is ≤1.5 × ULN; Blood urea\u002Furea nitrogen (UREA\u002FBUN) and Creatinine (Cr) are ≤1.5 × ULN; Coagulation function: International normalized ratio (INR) and Activated partial thromboplastin time (APTT) are ≤1.5 × ULN; Urine protein is less than 2+ (if baseline urine protein is ≥2+, a 24-hour urine protein quantification should be performed, and it is acceptable for inclusion if ≤1g);\n* 8.Women of reproductive age should agree to use contraceptive measures (such as intrauterine devices, hormonal contraceptives, or condoms) during the study period and for 6 months after the study ends; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; men should agree to use contraceptive measures during the study period and for 6 months after the study ends;\n* 9.The subject can understand the nature of this study, and the subject and\u002For legal representative voluntarily agrees to participate in this trial and signs the informed consent.\n\nExclusion Criteria:\n\n* 1.Patients who have previously received treatment with any HER2-targeted tyrosine kinase inhibitors (such as lapatinib, pyrotinib, neratinib, etc.);\n* 2.Those who do not meet the following requirements for the washout period from previous anti-tumor treatments before the first administration of the study drug: the washout time from the end of the last dose of previous anti-tumor treatment to the first administration of the study drug (calculated from the end of the last dose) is as follows: chemotherapy ≥3 weeks (oral fluorouracil ≥2 weeks; mitomycin C, nitrosoureas ≥6 weeks), small molecule targeted therapy ≥2 weeks, large molecule drugs (including immunotherapy) ≥4 weeks, radiotherapy ≥4 weeks (local palliative radiotherapy ≥2 weeks), Chinese medicine with anti-tumor indications ≥2 weeks, other anti-tumor treatments ≥4 weeks, investigational drugs or treatments that are not yet marketed ≥4 weeks;\n* 3.Received major organ surgery (excluding biopsy) or had significant trauma within 4 weeks before the first administration of the study drug;\n* 4.Spinal cord compression or brain metastasis, unless asymptomatic, stable, and has not required steroid treatment for at least 4 weeks before the start of the study treatment (before dosing);\n* 5.A history of other malignant tumors within the past 5 years, excluding cured cancers such as cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n* 6.Adverse reactions from previous anti-tumor treatments have not recovered to a grade of ≤1 according to CTCAE 5.0 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, thyroid hypothyroidism stable with hormone replacement therapy);\n* 7.The presence of uncontrollable third-space fluid accumulation (such as a large amount of pleural effusion, ascites, or pericardial effusion) that cannot be managed by drainage or other methods;\n* 8.Patients with gastrointestinal diseases that may affect drug absorption (such as Crohn's disease, intestinal obstruction, active peptic ulcer disease, etc.);\n* 9.Patients currently suffering from interstitial lung disease;\n* 10.Patients with any cardiac disease, including: (1) unstable angina; (2) clinically significant arrhythmias requiring medication; (3) myocardial infarction; (4) heart failure of grade 3 or higher; (5) echocardiography: left ventricular ejection fraction (LVEF) ≤50%; (6) 12-lead electrocardiogram: QTcF: females \\>470 milliseconds, males \\>450 milliseconds; (7) any other cardiac disease judged by the investigator to be unsuitable for participating in this trial;\n* 11.History of immunodeficiency, including HIV antibody test positive;\n* 12.Active hepatitis B or C (HBV DNA, HCV RNA test results at screening are not within the normal range of the central laboratory);\n* 13.According to the investigator's judgment, there are other serious accompanying diseases that endanger patient safety or affect the patient's ability to complete the study (such as uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg after taking antihypertensive drugs), diabetes (glycated hemoglobin \\>9.0%), autoimmune diseases, etc.);\n* 14.The investigator deems the subject unsuitable for other reasons to participate in this study.",{"count":133,"type":22},60,[26],"Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.",[29],[138,139,140,141,142,143],"HER2 mutation-positive","Non-Small Cell Lung Cancer (NSCLC)","Cholangiocarcinoma","Cervical Cancer","Salivary Gland Cancer","Neratinib tablets","2024-07-23",{"date":146,"type":38},"2024-07-25",{"date":148,"type":22},"2024-08-10",{"date":150,"type":22},"2026-04-15",{"name":44,"class":45},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100544899","phase-2-nilatinib-maleate-tablets-combined-with-capecitabine-in-the-treatment-of-her2-positive-advanced-esophagealesophagogastric-junctiongastric-adenocarcinoma-with-brain-metastases-100544899","NCT06374888","Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal\u002FEsophagogastric Junction\u002FGastric Adenocarcinoma With Brain Metastases","A Single-arm, Open, Multicenter Phase II Clinical Study of Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal\u002FEsophagogastric Junction\u002FGastric Adenocarcinoma With Brain Metastases","Inclusion Criteria:\n\n* Age ≥18 years old\n* Histologically or cytologically confirmed advanced esophageal\u002Fesophagogastric junction\u002Fgastric adenocarcinoma with brain metastases (clear imaging evidence of metastasis)\n* Tumor tissue was HER2 positive Her2-positive is defined as immunohistochemical (IHC) 3+ or IHC 2+ and in situhybridization (ISH) positive\n* Presence of a measurable lesion according to RECIST 1.1: presence of at least one non-radiation-treated lesion with a diameter ≥10 mm (lymph node lesion with a diameter ≥15 mm) that can be accurately measured at baseline on CT or MRI and can be repeatedly measured. If study participants only have lesions after radiotherapy, and the lesions have been clearly identified as radiological progression and can be measured, they can be selected as target lesions. The brain lesion must have a measurable target lesion, but it is not required to have a measurable targetlesion outside the brain\n* Corticosteroid dose did not increase one week before brain MRI examination\n* There is no limit to previous treatment options, including chemotherapy, radiotherapy, targeted drugs, antibody coupling drugs, immunosuppressants, etc\n* Cohort A: Patients with brain metastases who have not previously received central nervous system radiotherapy should be more than 2 weeks from the end of the last systemic therapy. Patients who developed new brain lesions after craniotomy were allowed to be included if they had not received postoperative radiotherapy and were at least 2 weeks removed from surgery.\n\nCohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For lesions that have received local treatment, there is clear evidence of progress in imaging examination, and those that have received radiotherapy can be selected as target lesions. Patients with multiple central nervous system lesions, only one or a few of which received stereotactic radiotherapy, and those with lesions that did not receive local treatment, may still participate in the study\n\n* Predicted survival ≥8 weeks\n* Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period\n* The patient can understand the situation of this study, and the patient and (or) legal representative voluntarily agree to participate in this trial and sign the informed consent\n\nExclusion Criteria:\n\n* Participants who have received chemotherapy or radiation therapy (including study drugs) within 2 weeks prior to study participation, or who have not fully recovered from adverse events (excluding hair loss) due to taking drugs for more than 4 weeks\n* Patients who have previously received anti-HER2 small-molecule TKI therapy progression\n* More than two seizures in the first 4 weeks of enrollment\n* Participants currently receiving any other study drug\n* History of allergic reactions caused by compounds chemically or biologically similar to neratinib\n* Concurrent use of enzyme-induced antiepileptic drugs (EIED), including phenytoin, carbamazepine, oxamazepine, phophenytoin, phenobarbital, pentobarbital, or primidone\n* Patients who were receiving any concurrent treatment for cancer during the study period, such as concurrent chemotherapy, radiation, or hormone therapy. Concurrent treatment with bisphosphonates is permitted, but should be started before the first dose of nelatinib\n* Present with co-existing medical conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmia, or mental illness\u002Fsocial conditions that would limit compliance with study requirements\n* Patients with known contraindications to MRI, such as pacemakers, shrapnel, or ocular foreign bodies\n* Patients with pial metastasis only\n* Severe malabsorption syndrome or inability to tolerate oral drugs\n* Any chronic disease that causes diarrhea with CTCAE≥2 at baseline\n* Women who are breastfeeding or whose blood or urine pregnancy test results are positive within 7 days before the first dosing of the study treatment\n* The investigators identified patients with any conditions that compromised patient safety, interfered with study evaluation, or had poor adherence",{"count":160,"type":22},28,[26],"To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal\u002Fesophagogastric junction\u002Fgastric adenocarcinoma with brain metastasis.",[164],"Her2-positive Advanced Esophageal\u002FEsophagogastric Junction\u002FGastric Adenocarcinoma With Brain Metastasis",[166,167,168,169,170],"Her2-positive","esophageal","esophagogastric junction","gastric adenocarcinoma","brain metastasis","2024-04-16",{"date":173,"type":38},"2024-04-19",{"date":175,"type":22},"2024-04-30",{"date":177,"type":22},"2027-07-30",{"name":44,"class":45},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":100},"100530204","phase-2-cvl237-tablets-in-the-treatment-of-advanced-solid-tumors-with-pten-deficiency-100530204","NCT06183736","CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency","A Single-arm, Open-label, Multicenter, Phase II Study of CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency","Inclusion Criteria:\n\n1. Aged 18-75 years (including those of 18 and 75 years old; patients over 60 years old cannot have more than 3 kinds of complications of heart, lung, liver and kidney function at the same time); the sex is not limited;\n2. Aged 18-75 years (including those of 18 and 75 years old; patients over 60 years old cannot have more than 3 kinds of complications of heart, lung, liver and kidney function at the same time); the sex is not limited;after standard treatment as determined by the investigator, or for whom there is no standard treatment, or who refuse the standard treatment;\n3. PTEN deficiency will be determined based on analysis of patient tumor samples and by testing PTEN protein expression using immunohistochemistry (IHC) at the central laboratory;\n4. Have at least one measurable lesion that meets the requirements of RECIST 1.1 ; If the lesion previously treated with local therapy (radiotherapy, ablation, interventional therapy, etc.) is the only lesion, there must be unequivocal imaging evidence of disease progression in this lesion;\n5. Eastern Cooperative Oncology Group (ECOG) score: 0-2;\n6. Expected survival time of more than 3 months;\n7. Good organ function level:\n\n   * Absolute neutrophil count (ANC)≥ 1.5 × 10\\^9\u002FL\n   * Platelets (PLT)≥ 75 × 10\\^9\u002FL\n   * Hemoglobin (Hb)≥ 90 g\u002FL\n   * Total bilirubin (TBIL)≤ 1.5 × ULN\n   * Alanine aminotransferase (ALT)≤ 2.5 × ULN;Patients with liver metastases or liver cancer: ≤ 5 × ULN\n   * Aspartate aminotransferase (AST)≤ 2.5 × ULN;Patients with liver metastases or liver cancer: ≤ 5 × ULN\n   * Serum creatinine clearance (Ccl)≤ 1.5 × ULN, or ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula)\n   * Activated partial thromboplastin time (APTT)≤ 1.5 × ULN\n   * International Normalized Ratio (INR)≤ 1.5 × ULN\n   * Ejection fraction (LVEF) ≥ 50% and Fridericia-corrected QT interval (QTcF) \\\u003C 450 ms for males and \\\u003C 470 ms for females\n8. Eligible patients (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner during the study and for at least 180 days after the last dose; Females of childbearing potential must not be breastfeeding, and females of childbearing potential must have a negative pregnancy test before the start of dosing;\n9. Voluntarily participate in this clinical trial, understand the study procedures and be able to sign the ICF in writing.\n\nExclusion Criteria:\n\n1. Patients who have progressed on previous treatment with any PI3K, mTOR or AKT inhibitors (except for patients who dropped out due to intolerance);\n2. Known hypersensitivity to any ingredient of CVL237;\n3. Those requiring OATP1B1 and OATP1B3 substrate drugs, CYP3A4\u002F5 substrate drugs, moderate and potent cytochrome P450 3A4\u002F5 inhibitors, and potent inducers of cytochrome P450 3A4\u002F5 for treatment;\n4. Received chemotherapy, radiotherapy, immunotherapy, biological agents, molecular targeted therapy or endocrine therapy and other antitumor drugs within 4 weeks before the first dose of the study drug, except for the following: nitrosoureas or mitomycin C within 6 weeks before the first dose of the study drug; oral fluorouracils and small molecular targeted drugs within 2 weeks before the first dose of the study drug or 5 half-lives of the drug (whichever is shorter);\n5. Participated as a subject in a clinical trial within 4 weeks prior to the first dose of the study drug;\n6. Patients who have undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the study drug, or require selective surgery during the study;\n7. Previously received allogeneic bone marrow transplantation or solid organ transplantation;\n8. Presence of third space fluid accumulation (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;\n9. The adverse reactions to previous antitumor treatment have not recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk);\n10. Patients with active brain metastasis, meningeal metastasis and central nervous system (CNS) involvement, who are not suitable for enrollment as judged by the investigator;\n11. Participants with impairment of gastrointestinal (GI) function or GI disease that, in the judgment of the investigator, could significantly alter the absorption of the study drug (e.g., ulcerative disease, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection);\n12. Subjects with a history of acute pancreatitis within 1 year prior to screening or subjects with a previous history of chronic pancreatitis;\n13. Uncontrolled pulmonary fibrosis, acute lung disease, interstitial lung disease, FEV1 (post-bronchiectasis) \\\u003C 70% predicted value at screening, or hepatic failure, etc.;\n14. Patients with active viral, bacterial, fungal or other infections requiring systemic treatment (such as active pulmonary tuberculosis), excluding nail bed fungal infection;\n15. Patients with HBV or HCV infection (defined as HbsAg and\u002For HbcAb positive and HBV DNA copies ≥ 1 × 104 copies\u002FmL or ≥ 2000 IU\u002FmL) or acute or chronic active hepatitis C;\n16. Patients with a history of immune deficiency, including positive HIV test, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;\n17. Had any heart disease within 6 months, including: (1) Angina pectoris; (2) Arrhythmia that requires medication or is clinically significant; (3) Myocardial infarction; (4) Cardiac failure; (5) Patients with any other heart disease judged by the investigator to be unsuitable for this study;\n18. Other concomitant diseases that seriously jeopardize the safety of the patient or affect the completion of the study \\[e.g. Uncontrolled hypertension (systolic\u002Fdiastolic blood pressure ≥ 140\u002F90 mmHg after administration of antihypertensive drugs), diabetes mellitus (HbA1c ≥ 8.0% (63.9 mmol\u002Fmol), thyroid disease, etc.\\] according to the judgment of the investigator;\n19. Received a live vaccine within 30 days prior to the first dose of the study drug, or plan to receive a live vaccine during the study;\n20. The investigator considers that there are other reasons for the unsuitability of the subject participating in the study.",{"count":187,"type":22},98,[26],"This is a single-arm, open-label, multicenter, phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency. It is planned to enroll patients with PTEN deficiency advanced solid tumors of different tumor types (PTEN deficiency gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer and melanoma etc.) to evaluate the preliminary efficacy, safety and pharmacokinetic profile of CVL237 tablets in patients with PTEN deficiency advanced solid tumors of different tumor types.",[191],"Advanced Solid Tumors",[193,63,194,64,195,67,68,196,197],"PTEN deficiency","prostate cancer","colorectal cancer","melanoma","CVL237 Tablets","2023-12-25",{"date":200,"type":38},"2023-12-27",{"date":202,"type":22},"2023-12-20",{"date":204,"type":22},"2027-06-30",{"name":44,"class":45},""]