[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Advenchen Laboratories Nanjing Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100626688","phase-1-catequentinib-hydrochloride-al3818-drug-drug-interaction-study-in-healthy-volunteers-100626688",false,"NCT07438886","Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers","A Non-Randomized, Open-Label Clinical Study of Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) With Itraconazole and Ticagrelor in Healthy Volunteer Subjects","Inclusion Criteria:\n\nA subject is eligible for enrollment in the study only if all of the following criteria are met:\n\n1. Male or female; aged between 18 and 45 years old (inclusive).\n2. Male subjects weight ≥50 kg, female subjects weight ≥45 kg, body mass index (BMI) between 19.0 and 26.0 kg\u002Fm2 , BMI= weight (kg)\u002Fheight2 (m2 ) (inclusive).\n3. Physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, urine routine, blood biochemistry, blood lipid, coagulation function and thyroid function, etc.) and chest X-ray at screening showed no clinically significant abnormalities, and the clinical study doctor judged them qualified.\n4. The subject voluntarily signed a written informed consent form and is able to communicate well with the investigator.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria before screening will be excluded from the study:\n\n1. History of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory, endocrine, immune, blood and lymphatic, skeletal\u002Fmuscular, nervous and other system diseases), history of liver and kidney insufficiency, history of mental diseases, history of drug dependence, bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent gastrointestinal bleeding), history of active pathological bleeding, history of intracranial hemorrhage, family history of hypertension;\n2. History of dysphagia or any gastrointestinal diseases affecting drug absorption, digestive system diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months;\n3. Allergic to any component of the investigational product (AL3818, itraconazole capsule, ticagrelor tablet) and its excipients, with a history of drug or food allergy, or history of specific allergy (asthma, urticaria, eczema, etc.);\n4. Subjects who have had clinically significant major diseases or major surgical procedures within 3 months prior to;\n5. Subjects who donated blood within 3 months, or planned to donate blood within the study period, or Subjects who had blood transfusion or blood loss ≥200 mL within 4 weeks;\n6. Participation in any clinical trial as a subject within 3 months;\n7. Subjects with drug abuse history within 5 years or drug use within 3 months or positive urine drug abuse screening at baseline;\n8. Anyone who has taken any prescription, over-the-counter, vitamin or herbal medicine within 2 weeks or 5 half-lives (whichever is longer);\n9. Any drug known to be an inhibitor or inducer of CYP3A4 enzymes or a sensitive substrate (Appendix 4), any drug known to be a P-gp inhibitor or substrate (Appendix 5), any drug known to be a BCRP inhibitor or substrate (Appendix 6), or any drug known to cause a risk of torsades de pointes (TdP) (Appendix 7) within 4 weeks;\n10. Vaccination within 3 months or planned during this trial;\n11. Subjects with a history of bleeding and needle phobia, unable to tolerate intravenous indwelling needle injection;\n12. Subjects with neurological\u002Fpsychiatric, respiratory, cardiovascular, digestive tract, blood and lymphatic system, endocrine, musculoskeletal disorders, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the study results at screening;\n13. Screening or baseline 12-lead ECG with QTcF interval ≥ 450 ms (males), QTcF interval ≥ 460 ms (females); or ECG abnormal and considered abnormal and clinically significant by the investigator;\n14. Laboratory test results during screening period or baseline period meet the following abnormal range requirements and are considered abnormal and clinically significant by the investigator:\n\n    1. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ULN;\n    2. Abnormal coagulation function: activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≥ULN;\n    3. Abnormal thyroid function: Free triiodothyronine (FT3) or free thyroxine (FT4) or thyroid stimulating hormone (TSH) higher than ULN;\n15. Subjects with hepatitis B surface antigen quantitative determination positive, hepatitis C antibody quantitative determination positive, human immunodeficiency virus antigen antibody determination positive or treponema pallidum antibody determination positive at screening period or baseline period;\n16. Have special requirements for diet and fail to comply with the diet and corresponding regulations provided by the clinical trial institution;\n17. Those who cannot control special diet (including pitaya, mango, grapefruit and\u002For xanthine diet, caffeine-containing food or beverage, etc.) during the trial;\n18. Strenuous exercise within 48 hours prior to the first dose, or planned strenuous exercise during the trial;\n19. Regular drinkers within 6 months or during the trial, i.e. drinking more than 21 units of alcohol (male) or 14 units of alcohol (female) per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or unable to stop drinking during the trial, or positive alcohol breath test at baseline;\n20. Smoking more than 5 cigarettes per day in the 3 months, or using any tobacco products during the trial;\n21. Pregnant or lactating women or those with positive blood pregnancy test results;\n22. Subjects who have used long-acting estrogen or progesterone injection or implant tablets within 6 months or during the trial;\n23. Women of childbearing age who have had unprotected sex with their partners within 14 days prior to screening;\n24. Male or female subjects of childbearing potential do not agree to use an effective method of contraception from the time of signing informed consent until 6 months after the last dose (see Section 10.3 for details of specific methods of contraception);\n25. Sperm or egg donation or fertility planning within 6 months from signing the informed consent form to the last dose;\n26. Vulnerable subjects such as the investigator himself\u002Fherself, relevant personnel of the study site and their family members, students and subordinates of the investigator, and employees of the sponsor;\n27. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this clinical trial.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a non-randomized, open-label, fixed-sequence drug-drug interaction study to evaluate the effects of itraconazole and ticagrelor on the pharmacokinetics of catequentinib hydrochloride (AL3818) in healthy volunteers.",[28],"Healthy Volunteer","NOT_YET_RECRUITING","2026-02-23",{"date":32,"type":33},"2026-02-27","ACTUAL",{"date":35,"type":22},"2026-03-02",{"date":37,"type":22},"2027-03-31",{"name":39,"class":40},"Advenchen Laboratories Nanjing Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100606709","phase-1-a-study-of-al58805-in-patients-with-advanced-tumors-100606709","NCT07179081","A Study of AL58805 in Patients With Advanced Tumors","Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be eligible:\n\n1. Patients with histologically or cytologically confirmed advanced tumors (including but not limited to lymphoma, colorectal cancer, breast cancer, pancreatic cancer, lung cancer, head and neck cancer, bladder cancer, cholangiocarcinoma) who lack effective standard treatment options or have failed conventional standard treatments (due to disease progression or intolerable toxicity).\n2. Previous treatment with cytotoxic chemotherapy, with at least 4 weeks between the end of chemotherapy and enrollment, and recovery from previous chemotherapy toxicities to ≤ Grade 1 (except alopecia).\n3. Must have measurable lesions according to RECIST 1.1 criteria.\n4. Major organ function: Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL (1500\u002Fmm3), platelets ≥75 × 10\\^9\u002FL, hemoglobin ≥9g\u002FdL. Serum total bilirubin ≤2 × upper limit of normal (ULN). Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin. For patients without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal.\n5. Age ≥18 years; ECOG performance status (PS) 0 or 1.\n6. Expected survival time of at least 12 weeks.\n7. No malabsorption or other gastrointestinal diseases affecting drug absorption.\n8. For women of childbearing potential: Negative pregnancy test before treatment and use of medically approved contraception during treatment and for 3 months after treatment ends. Must be non-lactating.\n9. For male subjects: Surgical sterilization or use of medically approved contraception during treatment and for 3 months after treatment ends.\n\nAbility to understand and sign informed consent.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded:\n\n1. Known allergy to the investigational drug or drugs with similar chemical structures.\n2. Use of unapproved drugs or other investigational drugs within 30 days before enrollment.\n3. Status of the organ systems:\n\n   Current symptomatic brain metastases or leptomeningeal metastases, or central nervous system (CNS) metastases with uncontrolled symptoms within 8 weeks of first dose.\n\n   Uncontrolled hypertension requiring multiple medications (Grade 2 or higher). Acute myocardial infarction within 6 months. Current arrhythmias (e.g., long QT syndrome, Bazett's corrected QTc ≥480 ms). NYHA Class III or IV heart failure. Poorly controlled diabetes. Any unstable systemic disease (including active infection, angina, hepatic, renal, or metabolic diseases).\n\n   Presence of ascites or pleural effusion (CTCAE 5.0 ≥ Grade 2). Persistent diarrhea (average watery stools ≥1 per day). History of definite neurological or psychiatric disorders (e.g., epilepsy, dementia, mood disorders).\n4. The functional level of each organ： Urine protein ≥++ and 24-hour urine protein \\>1.0 g. Patients treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs, should have an international normalized ratio (INR) of prothrombin time ≤1.5. In this case, low-dose warfarin (1mg, orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) can be used for prophylactic purposes. All other conditions are considered exclusion criteria.\n\n   Patients with active\u002Fvenous thrombosis events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.\n5. Previous treatment with the investigational drug.\n6. Patients exhibiting hepatitis B surface antigen (HBsAg) positivity with HBV DNA concentrations ≥10⁴ copies\u002FmL (equivalent to 2000 IU\u002FmL) must initiate antiviral therapy prior to study consideration. Eligibility for enrollment is contingent upon achieving sustained HBV-DNA suppression below these threshold values. Antiviral therapy will be maintained throughout the study period with concurrent monitoring of hepatic function parameters and quantitative HBV DNA levels. The exclusion criteria further encompass individuals with detectable HCV antibodies or HCV RNA, HIV seropositivity, congenital\u002Facquired immunodeficiencies, or prior organ transplantation history.\n7. Concurrent other anti-tumor treatments. Other conditions deemed unsuitable by the investigator.",{"count":50,"type":22},40,[25],"This Phase I clinical trial is a dose-escalation, multicenter study in patients with advanced solid tumors. It includes tolerance studies of sequential multiple oral doses of AL58805 and pharmacokinetic studies of single and multiple doses, analyzing the tolerance range of multiple doses, observing the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in solid tumor patients, and assessing the reversibility of toxicity and the relationship between toxicity and dose.",[54],"Advanced Tumors","RECRUITING","2025-09-15",{"date":58,"type":33},"2025-09-17",{"date":60,"type":33},"2020-12-20",{"date":62,"type":22},"2026-01-26",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100535113","phase-3-a-phase-iiii-study-of-al8326-in-small-cell-lung-cancer-100535113","NCT06247605","A Phase IIII Study of AL8326 in Small Cell Lung Cancer","Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment","Inclusion Criteria:\n\n1. All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;\n2. Age ≥ 18 years, male or female;\n3. Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies \\*);\n4. At least one measurable tumor lesion according to RECIST 1.1 \\*\\*;\n5. Expected survival time of at least 12 weeks;\n6. ECOG (PS) score of 0 to 2;\n7. Subject has adequate organ and bone marrow function and meets the following laboratory criteria:\n\n   1. Blood routine test (without red blood cell or platelet transfusion or hematopoietic factor drug correction within 14 days before screening): absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (1500\u002Fmm3), platelets ≥ 80 × 10\\^9\u002FL; hemoglobin ≥ 9.0 g\u002FdL;\n   2. Liver function: serum total bilirubin ≤ 1.5 × ULN (upper limit of normal), except for patients with Gilbert 's syndrome (persistent or recurrent hyperbilirubinemia, manifested as unconjugated bilirubin elevation in the absence of hemolysis or pathological evidence of liver); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for patients without liver metastasis, and ALT and AST ≤ 5 × ULN for patients with liver metastasis;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN and estimated standard cendogenous creatinine clearance rate ≥ 60 ml\u002Fmin by Cockcroft-Gault formula, Ccr (ml\u002Fmin) = \\[(140-age) × body weight (kg)\\]\u002F\\[72 × Scr (mg\u002Fdl)\\], calculated for females × 0.85;\n   4. Coagulation function: international normalized ratio (INR) ≤ 1.5;\n   5. Left ventricular ejection fraction (LVEF) \\> 50% at screening. 8.1) Female: For female subjects of childbearing potential, they must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically approved method of contraception (condom, sponge, gel, diaphragm, IUD, oral or injectable contraceptive, subcutaneous implant, etc.) during and for 3 months after treatment; they must be non-pregnant and lactating. Female subjects are considered fertile if they are menopausal but have not reached post-menopausal status (menopause of 12 consecutive months or more, with no cause other than menopause) and have not undergone sterilization (removal of ovaries and\u002For uterus). Their sexual partner agrees to use a medically licensed method of contraception during the subject's treatment and for 3 months after completion; 2) Males: surgical sterilization or agreement to use medically licensed contraception during and for 3 months after the end of treatment; their sexual partners agree to use medically licensed contraception during and for 3 months after the end of the subject's treatment;\n\n9\\. Capable and willing to comply with protocol requirements during the study and subsequent procedures.\n\nExclusion Criteria:\n\n1. Known uncontrollable hypersensitivity to AL8326 similar compounds;\n2. Having previously used AL8326 tablets;\n3. Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);\n4. Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;\n5. Having significant gastrointestinal history or current illness, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, and clinical difficulty in controlling chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases in the past 3 months, which may affect the intake, transport or absorption of drugs as judged by the investigator, or who have previously undergone total gastrectomy;\n6. Having other important primary diseases, such as single agent uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 95 mmHg), arrhythmia requiring clinical intervention (such as long QT syndrome, QTcF \\> 470 ms), abnormally prolonged arrhythmia caused by unstable coronary artery disease, decompensated congestive heart failure (New York Heart Association(NYHA) class III or IV) or myocardial infarction, unstable angina pectoris, ascites or pleural effusion with uncontrolled within 6 months before the administration of the investigational product (CTCAE 5.0 ≥ 2), active autoimmune diseases, mental illness, symptomatic or interstitial lung disease requiring treatment, thyroid disease that may seriously affect the trial evaluation;\n7. Previously received cytotoxic chemotherapy and\u002For immunotherapy, and the end of the last dose is at least 4 weeks apart from the first dose of study drug; the end of anti- tumor herb medicine is at least 14 days apart; the end of nitroso or mitomycin was at least 6 weeks apart, and tyrosine kinase inhibitors (TKIs) class molecular targeted drugs were at least 4 weeks apart; the treatment of brain metastases\u002Fbone metastases had to be at least 2 weeks apart; and had recovered to ≤ Grade 1 from the toxicity of previous treatment \\[except for the following: a. alopecia; b. long-term toxicity caused by radiotherapy, which could not be recovered in the judgment of the investigator; c. platinum-induced Grade 2 and the following neurotoxicity such as hearing impairment (according to the Common Terminology Criteria for Adverse Events CTCAE V5.0)\\];\n8. Had arterial thrombosis or severe venous thromboembolic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;\n9. Having imaging findings indicating that the tumor has invaded around important vessels at screening or the tumor is likely to invade important vessels and cause fatal massive hemorrhage during the subsequent study period as judged by the investigator;\n10. Uncontrolled infection within 14 days prior to first dose;\n11. Screening urine routine showed urine protein ≥ + +, and 24-hour urine protein \\> 1.0 g;\n12. Having active bleeding within 3 months before screening or at high risk of bleeding as judged by the investigator;\n13. Been receiving anticoagulants or vitamin K antagonists (e.g., warfarin, heparin, or their analogues) during the screening period \\[low-dose anticoagulants such as warfarin (no more than 1 mg daily orally), low-dose heparin (no more than 12,000 U daily), or low-dose aspirin (no more than 100 mg daily) were permitted for prophylactic purposes provided INR was ≤ 1.5\\];\n14. Having positive test results for hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody, or active hepatitis B (defined as hepatitis B virus HBV DNA ≥ 2000 IU\u002FmL or HBV DNA ≥ 10 \\^ 4 copies);\n15. Participated in other clinical trials (excluding observational or vitamin studies) within 4 weeks before informed consent;\n16. Having received major surgical treatment within 6 weeks prior to screening (patients must be fully recovered and stable before the start of treatment) or serious unhealed wounds, ulcers or fractures at screening;\n17. Having a history of organ transplantation or being prepared to undergo organ transplantation;\n18. Other reasons that, in the discretion of the investigator, would make participation in this study inappropriate.\n\nNotes:\n\n\\*1 new line of therapy refers to a change in treatment regimen due to disease progression rather than toxicity or other reasons; after progression on the first treatment, reuse of the same treatment regimen is also a new line of therapy;\n\n\\*\\* Lesions treated with radiotherapy or locoregional therapy must have radiographic evidence of disease progression to be considered target lesions. If there is only one measurable lesion, the lesion cannot be brain lesion.",{"count":72,"type":22},243,[74],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.",[77],"Small Cell Lung Carcinoma","2024-01-30",{"date":80,"type":33},"2024-02-08",{"date":82,"type":33},"2023-10-26",{"date":84,"type":22},"2029-07",{"name":39,"class":40},""]