[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuanzhu Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":232},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,66,87,113,139,163,182,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100638382","phase-3-the-clinical-trail-to-evaluate-the-efficacy-and-safety-of-anaprazole-sodium-enteric-coated-tablets-combined-with-bismuth-containing-quadruple-therapy-in-eradicating-helicobacter-pylori-100638382",false,"NCT07606833","The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori","A Multicenter, Randomized, Double Blind, Double-simulated, Parallel Control of Positive Drug Phase III Clinical Study Evaluating the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Containing Bismuth in Quadruple Therapy for the Eradication of Helicobacter Pylori","Inclusion Criteria:\n\n1. Aged 18-75 years\n2. During the screening visit, the participants were determined to be Hp-positive by 13C-UBT and Hp eradication therapy was required by the investigator.\n3. Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Known allergic history to Anaprazole or Esomeprazole, or amoxicillin or clarithromycin and bismuth(including any related excipients ).\n2. Have a history of severe rapid-onset hypersensitivity to β-lactam agents (such as cephalosporins, carbapenems, monocyclic β-lactam).\n3. The participant has Zollinger-Ellison syndrome.\n4. Participants known to have acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury (AGML) or acute duodenal mucosal injury (ADML).\n5. Participants in the trial had previously undergone surgeries or procedures that might affect gastric acid secretion or drug absorption.\n6. Participants with a history of malignant tumors within 5 years prior to screening (Cutaneous basal cell carcinoma or cervical carcinoma in situ that has been cured is excluded).\n7. The subject has severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine or hematological diseases that the investigator believes may affect the study results and the safety of the participants.\n8. Laboratory examination during the screening period showed ALT or AST \\> 2 times of the upper limit of normal value, TBIL \\> 1.5 times of the upper limit of normal value; renal function Cr \\> 1.5 times of the upper limit of normal value (one review was allowed in the study, and those who still did not meet the requirements for inclusion were excluded).\n9. Participants with severe arrhythmia, multigenic premature ventricular contractions (PVC), second-degree or higher atrioventricular block, ventricular arrhythmia or prolonged QT interval (QTcF\\> 450ms in male and 470ms in female).\n10. Previously received Helicobacter pylori eradication treatment.\n11. Used PPI or P-CAB preparations within 2 weeks before 13C-UBT examination during the screening period; Antibiotics, bismuth-containing preparations, or traditional Chinese medicine with antibacterial effects were used within 4 weeks before 13C-UBT test during the screening period.\n12. Those with chronic drug abuse in the 12 months prior to screening.\n13. Those with alcohol dependence in the 12 months prior to screening.\n14. Participated used experimental drugs\u002Fdevices in other drug\u002Fdevice clinical studies within 3 months before screening.\n15. Female participants who are suspected or already pregnant, breastfeeding; and female participant or a partner of male participant who are planning to become pregnant during the study.\n16. Others were deemed unsuitable for the trial .","ALL","18 Years","75 Years",{"count":20,"type":21},556,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.",[27],"HELICOBACTER PYLORI INFECTIONS","NOT_YET_RECRUITING","2026-05-19",{"date":31,"type":32},"2026-05-26","ACTUAL",{"date":34,"type":21},"2026-06-10",{"date":36,"type":21},"2027-03-18",{"name":38,"class":39},"Xuanzhu Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100619520","phase-4-a-study-of-the-pharmacokinetics-and-safety-of-anaprazole-sodium-in-special-populations-100619520","NCT07345689","A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations","A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;\n2. Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;\n3. Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);\n4. Body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive);\n5. Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;\n6. Subjects in the hepatic impairment group must also meet all of the following additional criteria:\n\n   Subjects with chronic liver injury due to primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), classified as Child-Pugh Grade B hepatic insufficiency; Clinically diagnosed cirrhosis; eGFR \\> 59 mL\u002Fmin; Subjects are either those with a stable concomitant medication regimen (for hepatic impairment\u002Fcomplications\u002Fother diseases) for ≥2 weeks pre-dose not requiring anticipated adjustment (excluding, e.g., diuretics\u002Finsulin), or those not on such medications;\n7. Subjects in the renal impairment group must also meet all of the following additional criteria:\n\nDiagnosed with chronic kidney disease (CKD), defined as the presence of any marker of kidney damage or GFR \\\u003C 60 mL\u002Fmin for more than 3 months (evidence may include outpatient records, inpatient records, or laboratory reports); GFR must meet the following criteria: Moderate renal impairment (CKD Stage 3): 30-59 mL\u002Fmin (inclusive); Severe renal impairment (CKD Stage 4): 15-29 mL\u002Fmin (inclusive); Note: Staging will be determined solely based on the second scheduled GFR measurement during the screening period; Renal function must be stable, defined as meeting either of the following criteria based on two GFR measurements taken prior to dosing (with at least a 3-day interval between measurements): Both results fall within the same CKD stage; or the fluctuation between the two GFR results is \\\u003C10% (calculated as: \\[(Second result - First result) \u002F First result\\] × 100%).\n\nExclusion Criteria:\n\n1. Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;\n2. QTcF (male) \\> 470 ms, QTcF (female) \\> 480 ms;\n3. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;\n4. History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;\n5. History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;\n6. Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;\n7. Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;\n8. Use of moderate or strong CYP3A4 inhibitors\u002Finducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;\n9. Use of proton pump inhibitors (PPIs, e.g., rabeprazole, pantoprazole, esomeprazole) within 2 weeks prior to screening or planned concomitant use during the study; medications known to affect serum creatinine clearance (e.g., calcium dobesilate, trimethoprim\u002Fsulfamethoxazole, cimetidine); drugs prone to cause liver injury (e.g., non steroidal anti inflammatory drugs, antibiotics, antituberculosis agents, antifungals, glucocorticoids); or drugs with high plasma protein binding (e.g., warfarin, dicoumarol, diazepam, phenylbutazone, digitoxin);\n10. Consumption of special diets (including pitaya, mango, pomelo, and\u002For xanthine containing foods such as chocolate) within 2 weeks prior to dosing, and\u002For habitual excessive intake of tea, coffee, grapefruit\u002Fgrapefruit juice, or caffeinated beverages (average \\>8 cups per day, 200 mL per cup);\n11. History of excessive alcohol consumption, defined as \\>14 units per week on average, within the 3 months preceding screening (where 1 alcohol unit equals 360 mL of beer, 45 mL of 40% distilled spirits, or 150 mL of wine);\n12. Positive result on alcohol breath test or urine drug screening at screening;\n13. Average cigarette consumption of ≥10 cigarettes per day within 3 months prior to screening;\n14. History of drug abuse or substance misuse;\n15. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test;\n16. Intolerance to venipuncture or history of needle\u002Fphobia syncope;\n17. Use of any investigational drug within 3 months prior to screening or planned participation in another clinical trial during this study;\n18. Other conditions deemed by the investigator to compromise the subject's suitability for the study;\n\n    Healthy Subjects will be excluded if they meet any of the following criteria:\n19. History of hepatic impairment or renal impairment;\n20. Any clinically significant active or chronic disease affecting major organ systems (e.g., circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems) at screening, or any other medical condition that could potentially confound the interpretation of study outcomes;\n21. Clinically significant abnormalities (as judged by the investigator) in physical examination, vital signs, laboratory tests, 12 lead ECG, abdominal ultrasound, or chest X ray;\n22. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody;\n23. Administration of any prescription medication, non prescription drug, vitamin supplement, or herbal preparation within 14 days prior to screening;\n\n    Subjects in the hepatic impairment group will be excluded if they meet any of the following criteria:\n24. Subjects who present with any of the following conditions and are deemed by the investigator as unsuitable for this study will be excluded:\n\n    Prior liver transplantation; Diseases such as biliary cirrhosis or extrahepatic biliary obstruction;\n\n    Diagnosis of liver cancer or other malignant tumors, with the following exceptions:\n\n    Certain completely cured cancers after surgical resection, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; Liver cancer patients who have received radical therapy with no recurrence; Liver cancer patients classified as BCLC stage 0. Acute liver failure; History of esophageal or gastric variceal bleeding within 3 months prior to screening;\n25. Laboratory test results at screening meeting any of the following criteria:\n\n    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN);\n    2. Absolute neutrophil count \\\u003C 0.75 × 10⁹\u002FL;\n    3. Hemoglobin \\\u003C 80 g\u002FL;\n    4. Alpha fetoprotein (AFP) \\> 100 ng\u002FmL;\n    5. Platelet count \\\u003C 40 × 10⁹\u002FL; or any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n26. Positive screening result for HIV antigen\u002Fantibody; Positive syphilis antibody test result with a confirmatory positive rapid plasma reagin (RPR) test;\n27. In addition to the primary hepatic condition, subjects will be excluded if, at screening, they present with any other severe systemic disease-including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardiovascular\u002Fcerebrovascular disorders-that in the investigator's judgment would make them unsuitable for the study;\n\n    Subjects in the renal impairment group will be excluded if they meet any of the following criteria:\n28. Acute renal failure, prior kidney transplantation, or requirement for renal dialysis during the study;\n29. Subjects will be excluded if, in addition to chronic kidney disease and its complications, they have a history or current evidence of any other severe systemic disorder-including but not limited to significant gastrointestinal, respiratory, neurological, hematological, endocrine, oncological (except for completely resected in situ basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast), immunological, psychiatric, or cardiovascular\u002Fcerebrovascular disease-that, in the investigator's opinion, would make participation in the study inappropriate;\n30. ALT ≥ 2 × ULN, AST ≥ 2 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Absolute neutrophil count \\\u003C 1.3 × 10⁹\u002FL; Hemoglobin \\\u003C 80 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n31. Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, or Left ventricular ejection fraction (LVEF) \\\u003C 50% at screening;\n32. Positive result for HIV antigen\u002Fantibody; Positive syphilis antibody test result, with a confirmatory positive rapid plasma reagin (RPR) test;\n\n    Elderly subjects will be excluded if they meet any of the following criteria:\n33. Subjects will be excluded if they have any other severe systemic disease at screening - including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, oncologic (except completely resected in situ basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast), immunologic, psychiatric, or cardiovascular\u002Fcerebrovascular disorders - and if, in the investigator's judgment, participation would be inappropriate;\n34. Fasting blood glucose \\> 7.0 mmol\u002FL;\n35. ALT ≥ 1.5 × ULN, AST ≥ 1.5 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Creatinine \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Hemoglobin \\\u003C 100 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n36. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody.",true,{"count":50,"type":21},60,[52],"PHASE4","The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.",[55,56,57],"Hepatic Insufficiency","Renal Insufficiency","Elderly","2026-01-07",{"date":60,"type":32},"2026-01-16",{"date":62,"type":21},"2026-01-30",{"date":64,"type":21},"2027-06-30",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100618354","phase-4-drug-drug-interaction-study-of-rifampin-and-anaprazole-sodium-100618354","NCT07330531","Drug-drug Interaction Study of Rifampin and Anaprazole Sodium","A Drug-drug Interaction Study to Evaluate the Effects of Rifampin Capsules on the Pharmacokinetics of Anaprazole Sodium Enteric-coated Tablets in Healthy Adult Subjects","Inclusion Criteria:\n\n1. Healthy male or female subjects aged 18-45 years (including boundary values);\n2. Male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg\u002Fm2 (including boundary value);\n3. No mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, history of systemic, endocrine and metabolic abnormalities;\n4. The subjects agreed to use effective contraception and had no plans to donate sperm or eggs from the time of trial screening until 6 months after the last dose;\n5. The subjects should be able to communicate well with the researchers, understand and comply with the requirements of the study, and understand and sign the informed consent.\n\nExclusion Criteria:\n\n1. Subjects with a specific allergic history (e.g., urticaria, eczema), an allergic constitution (e.g., allergy to two or more drugs, foods such as milk or pollen), a known allergy to anaprazole sodium or similar drugs, or an allergy to rifampin or its similar antibacterial drugs;\n2. During screening, there are clinical significant abnormal results in physical examination, laboratory tests, 12-lead electrocardiogram, chest x-ray examination or abdomen B ultrasound examination;\n3. Subjects with a history of drug abuse (including regular use of sedatives, hypnotics, or other addictive substances) within 12 months before screening; or who have used illicit drugs; or test positive in urine drug screening;\n4. Subjects who smoked more than 5 cigarettes per day within the 3 months before screening, or who could not stop using any tobacco products during the study;\n5. Alcohol breath test positive o regular drinkers within 6 months before screening, drinking more than 14 units per week \\[1 unit is equivalent to 350 mL of beer (5%), 45 mL of spirits (40%) or 150 mL of wine (12%)\\];\n6. Use any prescription drugs or traditional Chinese medicine within 4 weeks prior to the first dose, or use any OTC drugs or dietary supplements within 2 weeks before the first dose;\n7. Participated in other clinical trials and used investigational drugs within 3 months before screening;\n8. Those who received live vaccine within 2 weeks before the first dose, or planned to receive live vaccine during the study or within 7 days after the study was completed;\n9. Blood donation (including component blood donation) or blood loss of 400 mL within 3 months before screening, or blood transfusion; Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before screening;\n10. Have a history of major disease, major surgery, or significant trauma within the 3 months prior to screening, or who plan to undergo surgery during the study;\n11. Subjects with dysphagia or a history of gastrointestinal disorders that may affect drug absorption or cause clinically significant symptoms (e.g., gastrectomy or small bowel resection, atrophic gastritis, chronic intestinal diseases, gastrointestinal bleeding, obstruction, etc.), or those with acute gastrointestinal conditions (such as nausea, vomiting, diarrhea, abdominal pain, constipation, etc.) within the week prior to screening;\n12. Female subjects during pregnancy and lactation and female subjects of reproductive age who cannot take contraception as required;\n13. HBsAg, HCV Ab, Treponema pallidum antibody, HIV Ab test results are positive;\n14. Those who have special dietary requirements (including lactose intolerance) and are unable to comply with the provided diet and corresponding regulations;\n15. Those who have consumed a special diet (including pitaya, mango, pomelo, and\u002For xanthine-containing foods, chocolate) and\u002For have regularly consumed excessive amounts of tea, coffee, grapefruit\u002Fgrapefruit juice, and\u002For caffeinated beverages (averaging more than 8 cups per day, with each cup being 200 mL) within the 2 weeks prior to the first dose, thereby potentially affecting drug absorption, distribution, metabolism, or excretion;\n16. Use of any drug that inhibits or induces hepatic metabolism within 30 days prior to the first dose: Inducer such as barbiturates, carbamazepine, phenytoin sodium, rifamequine; Inhibitors such as cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrroles, etc.);\n17. Those who cannot tolerate blood collection by venipuncture or whose blood vessels are in poor condition;\n18. Other subjects deemed unsuitable to participate in the study by the investigator.","45 Years",{"count":75,"type":21},24,[52],"A drug-drug interaction study designed to evaluate the drug-drug interaction between rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects",[79],"Drug-drug Interaction Study","2026-01-04",{"date":82,"type":32},"2026-01-09",{"date":80,"type":21},{"date":85,"type":21},"2027-07-21",{"name":38,"class":39},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":40},"100593720","phase-3-a-clinical-trial-of-anaprazole-for-treating-reflux-esophagitis-100593720","NCT07010107","A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.","Efficacy and Safety of Anaprazole in the Treatment of Reflux Esophagitis: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Positive-Controlled Phase III Clinical Trial.","Inclusion Criteria:\n\n1. The patients provided voluntary signed informed consent forms.\n2. Aged ≥18 years and ≤75 years old.\n3. Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.\n\nExclusion Criteria:\n\n1. Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems.\n2. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.\n3. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.\n4. Patients confirmed to have active peptic ulcers or active upper\u002Flower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).\n5. Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders.\n6. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.\n7. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.\n8. Patients who tested positive for HIV, HBsAg, and\u002For HCV antibodies during screening.\n9. Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.\n10. Patients with abnormal liver function: AST and\u002For ALT levels ≥2.0×ULN, and\u002For total bilirubin (TBIL) levels ≥1.5×ULN.\n11. Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.\n12. Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).\n13. Patients with poorly controlled diabetes or hypertension.\n14. Patients who were unable to undergo esophagogastroduodenoscopy (EGD).\n15. Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.\n16. Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.\n17. Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.\n18. Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.\n19. Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.\n20. Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.\n21. Patients who had participated in other drug clinical trials within 3 months prior to randomization.\n22. Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.",{"count":95,"type":21},500,[24],"This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.",[99],"Reflux Esophagitis (RE)",[101,102,103],"Anaprazole","Rabeprazole","Reflux Esophagitis","RECRUITING","2025-09-23",{"date":107,"type":32},"2025-09-29",{"date":109,"type":32},"2025-07-30",{"date":111,"type":21},"2026-08",{"name":38,"class":39},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":40},"100498607","phase-1-a-study-of-xzb-0004-in-patients-with-solid-tumors-100498607","NCT05772455","A Study of XZB-0004 in Patients With Solid Tumors","A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours","Inclusion Criteria:\n\n1. Patient has signed informed consent before any trial related activities.\n2. Be 18 years of age or older and less than 75 years at the time of signing the informed consent.\n3. Part 1: Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy; Part 2：Have a histologically or cytologically confirmed diagnosis of a NSCLC or solid tumour malignancy.\n4. Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.\n5. Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n6. Have adequate organ function.\n7. Have recovered to ≤ grade 1 or Meet the requirements of the study from the effects of any prior cancer therapy, except for alopecia; irreversible neuropathy should have recovered to ≤ grade 2.\n8. Have a life expectancy greater than 3 months.\n9. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner.\n10. Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Previous use of AXL inhibitors and immunotherapy was consistent with protocol requirements.\n2. Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug.\n3. Received other unmarketed investigational drugs or treatments within 4 weeks or 5 times the elimination half-life prior to the first dose of the investigational drug.\n4. Treatment with systemic glucocorticoids (prednisone \\> 10mg per day or equivalent) or other immunosuppressive agents within 14 days before the first dose of a trial drug.\n5. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.\n6. Patient with heart function impaired or clinically significant heart disease.\n7. Any condition or illness that, in the opinion of the Investigator, would interfere with the evaluation of the safety of the study drug.\n8. History of immune deficiencies, including positive HIV antibody tests.\n9. Patient is in the active stage of HBV or HCV.\n10. History of solid organ transplant or bone marrow transplant.\n11. Any other malignant tumor has been diagnosed within 5 years.\n12. Has known Primary tumor of the central nervous system or central nervous system metastase.\n13. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage were present within 4 weeks before the first dose of the trial drug.\n14. Subjects with psychiatric disorders that may affect trial compliance.\n15. history of Alcoholism or drug abuse.\n16. Pregnant or breastfeeding.\n17. The researchers considered that there were some cases that were not suitable for inclusion.",{"count":121,"type":21},128,[123],"PHASE1","XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL.\n\nThis is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors.",[126,127],"Advanced Solid Tumor","NSCLC",[129,130],"XZB-0004","AXL inhibitor","2024-10-23",{"date":133,"type":32},"2024-10-28",{"date":135,"type":32},"2023-03-24",{"date":137,"type":21},"2027-02",{"name":38,"class":39},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":40},"100501100","phase-1-a-study-of-km501-in-patients-with-solid-tumors-100501100","NCT05804864","A Study of KM501 in Patients With Solid Tumors","A Single-arm, Open, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of the KM501 Double-antibody ADC in Subjects With Advanced Solid Tumors That Express, Amplify, or Mutate HER2","Inclusion Criteria:\n\n1. Voluntarily sign informed consent;\n2. At least 18 years old and less than 75 years old on the date of signing the informed consent;\n3. Subjects with histologically or cytologically confirmed advanced solid tumors who have developed disease progression since the last antitumor therapy, have no standard therapy available, do not tolerate or refuse standard therapy;\n\n   * Stage Ia: Subjects with advanced relapsed or metastatic solid tumors with HER2 expression or amplification or mutation, stage Ia may refer to (but is not limited to) specific types of tumors at stage Ib;\n   * Stage Ib: HER2-positive or expressed advanced breast cancer, advanced urothelial cancer, advanced gastric cancer or gastroesophageal junction adenocarcinoma, advanced ovarian cancer, and advanced endometrial cancer; Wild-type unresectable RAS and BRAF with HER2 expression or amplification in locally advanced or metastatic colorectal cancer; Advanced non-small cell lung cancer with a HER2 mutation. Other advanced tumors that are HER2-positive or expressed, HER2 amplified or mutated may be determined after discussion with the sponsor.\n4. The subject shall provide a previous HER2 test report. If there is no previous HER2 test result, the archived\u002Fbiopsied tumor tissue shall be provided for HER2 test in a 3A hospital or central laboratory. The HER2 status of the tumor tissue was determined by the investigator based on previous reports and test results from a 3A hospital or central laboratory. HER2 status is as follows:\n\n   * HER2 expression: IHC(3+), IHC(2+) or IHC(+);\n   * HER2 positive: IHC(3+) or IHC(2+) further test positive for ISH;\n   * HER2 amplification: ISH positive or NGS\u002FPCR confirmed HER2 amplification; • HER2 mutation: A HER2 mutation identified by NGS\u002FPCR\u002FSanger sequencing.\n5. The ECOG physical status score is 0 or 1 ;\n6. Lesion requirements: Stage Ia subjects need to have evaluable lesions; Stage Ib subjects must have at least one measurable target lesion. For targets previously treated with radiation, a measurable lesion is considered only if there is definite progression \\[see Appendix 3 for the definition of measurable lesions in solid tumors\\].\n7. Expected survival ≥12 weeks; 8. Within 7 days prior to initial drug administration, subjects must meet the following laboratory test values to ensure adequate organ and hematopoietic function (no blood transfusion, erythropoietin, granulocyte colony stimulating factor and other hematopoietic growth factor treatment, hepatoprotective therapy or other medical support treatment within 2 weeks prior to initial drug administration).\n\n9\\. A man or woman with reproductive potential must consent to the use of effective contraceptive methods starting with the signing of an informed consent form and continuing for six months from the end of the study treatment (Appendix 6). Pregnancy tests for women of reproductive age must be negative within 7 days of the first trial drug administration (fertility potential defined as premenopausal women who have not had a tubal ligation or hysterectomy, or within 1 year after menopause).\n\nExclusion Criteria:\n\n1. Subjects with known clinical or untreated central nervous system metastases, including meningeal metastases. Does not include: After radiation therapy, MRI\u002FCT examination at least 4 weeks prior to initial administration of the trial drug (showing stable lesions, no uncontrollable neurological symptoms or signs (e.g., epilepsy, headache, central nausea\u002Fvomiting, progressive neurological dysfunction, papilledema), or any treatment that does not require local (e.g., radiation) and systemic (e.g., Untreated asymptomatic brain metastases of mannitol or corticosteroids;\n2. Subjects with other malignancies within 5 years prior to initial administration of the experimental drug, except those with basal cell carcinoma, local squamous cell carcinoma of the skin, cervical carcinoma in situ, etc., who have not relapsed and metastasized after radical treatment;\n3. Subjects who have received chemotherapy, targeted therapy, or other systematic antitumor therapy within 4 weeks or 5 half-lives (whichever is older) prior to the initial administration of the test drug, and who have been treated with Chinese herbal or proprietary drugs for antitumor purposes within 2 weeks prior to the initial administration;\n4. Subjects who required systematic treatment with a dose of a corticosteroid \\>10 mg\u002F day equivalent to prednisone (see Appendix 9 for dose conversion) or other immunosuppressant within 14 days prior to initial administration of the trial drug or during the study period. Inhaled or topical doses ≤10 mg\u002F day equivalent to prednisone are permitted in the absence of active autoimmune disease. Short-term use of corticosteroids in doses \\>10 mg\u002F day equivalent to prednisone is permitted for the prevention (e.g., contrast allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by exposure to allergens);\n5. Subjects who received major surgery (as determined by the investigator) or radical radiation therapy within 4 weeks prior to initial administration of the test drug; Or received palliative radiotherapy within 2 weeks prior to initial administration of the trial drug; Or received radioactive agents (strontium, samarium, etc.) for therapeutic purposes within 8 weeks prior to the first dosing of the test drug;\n6. Subjects who have received other investigational drugs or treatments within 4 weeks prior to initial administration of the investigational drug;\n7. ILD (non-infectious) interstitial lung disease (ILD) requiring glucocorticosteroid treatment\u002For current clinically significant active or current ILD\u002F pneumonia, or suspicious ILD\u002F pneumonia that cannot be excluded by imaging during screening;\n8. Subjects with a known history of human immunodeficiency virus (HIV) infection; Laboratory test value: ANC≥ 1.5×109\u002FL; PLT≥ 100×109\u002FL Hb≥ 90 g\u002FL ; CR≤1.5 times the upper limit of normal range (ULN) and creatinine clearance ≥60 mL\u002Fmin (calculated according to Cockcroft-Gault formula); T-BIL ≤ 1.5 times ULN; ALT and AST Stage Ia: ≤ 2.5 times ULN;Stage Ib: ≤ 2.5 ULN, or ≤5 ULN (for subjects with liver metastases); INR and PT≤ 1.5 times ULN; APTT≤ 1.5 times ULN;\n9. Active hepatitis B virus (HBsAg positive and\u002For HBcAb positive with HBV-DNA\\> upper limit of quantification) or hepatitis C virus infection (HCV antibody positive and HCV RNA positive);\n10. Active infections requiring systematic treatment, including active tuberculosis, within 2 weeks prior to initial administration of the experimental drug;\n11. Pleural effusion, pericardial effusion, and abdominal effusion that could not be controlled by appropriate intervention were present within 4 weeks prior to initial administration of the test drug (note: Subjects with small amounts of effusion that could only be detected by imaging examination could be included);\n12. Subjects who have received previous organ transplants;\n13. Toxicity associated with previous antitumor therapy did not return to grade 1 or less (NCI-CTCAE v5.0) (except for alopecia, grade 2 hypoparathyroidism, or toxicity judged by the investigator to be of no safety risk);\n14. Subjects with active gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, glaucoma, uncontrolled diabetes and other serious concomitant diseases;\n15. Subjects with a known history of alcohol or drug abuse;\n16. Subjects with significant cardiovascular disease: Subjects with severe arrhythmias, acute myocardial ischemia, unstable angina pectoris, congestive heart failure (NYHA grade ≥ 2 (Appendix 5)), left ventricular ejection fraction (LVEF) \\\u003C50% within 6 months prior to initial administration of the experimental drug, Subjects with a history of long QT syndrome or a confirmed family history of long QT syndrome had heart-rate adjusted QTcF intervals of \\> 450 msec (male) and \\> 470 msec (female) using the Fridericia formula (Appendix 7);\n17. Uncontrolled hypertension with standard treatment (systolic blood pressure ≥140 and\u002For diastolic blood pressure ≥90 mmHg);\n18. History of cerebrovascular accidents, including transient ischemic attack or stroke, within 6 months prior to initial administration of the experimental drug;\n19. Subjects with stage Ib colorectal cancer: subjects with known activating mutations in exons 2, 3, and 4 of KRAS\u002FNRAS and V600E of BRAF (except those who are assessed to benefit by the investigator);\n20. Subjects with a history of grade 2 or above peripheral nerve disease;\n21. People who are known to be allergic to recombinant humanized anti-HER-2 bispecific antibody -MMAE conjugate drug and its components (L-histidine, histidine hydrochloride, polysorbate 80, etc.);\n22. Previous history of hypersensitivity, angioedema or severe hypotension caused by Herceptin or pertuzumab or biosimilar drugs;\n23. Subjects with a known mental illness that may affect compliance with the test;\n24. Pregnant women (positive pregnancy test before medication) or lactating women;\n25. The investigator considers that the subject is ineligible to participate in the clinical study for any clinical or laboratory abnormality or other reason.",{"count":147,"type":21},96,[123],"A single-arm, open, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the KM501 double-antibody ADC in subjects with advanced solid tumors that express, amplify, or mutate HER2",[151],"Advanced Solid Tumors",[153,154],"KM501","ADC","2023-04-05",{"date":157,"type":32},"2023-04-07",{"date":159,"type":21},"2023-04",{"date":161,"type":21},"2027-12",{"name":38,"class":39},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":40},"100498151","phase-1-a-study-of-km602-in-patients-with-advanced-solid-tumors-100498151","NCT05766527","A Study of KM602 in Patients With Advanced Solid Tumors","A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)\n2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1\n3. ECOG performance status of 0 or 1\n4. Life expectancy of ≥ 12 weeks\n5. Adequate baseline hematologic, renal, and hepatic function\n\nExclusion Criteria:\n\n1. Patients with meningeal metastasis or symptomatic central nervous system metastasis\n2. Any second malignancy active within the previous 5 years\n3. Any active, known, or suspected autoimmune disease\n4. Active or prior pneumonitis or interstitial lung disease\n5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation\n6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602\n7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab\n8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation\n9. Systemic treatment with corticosteroids (\\> 10 mg\u002Fday prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study\n10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C\n11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation\n12. Active infection requiring therapy at the time of the first dose of KM602\n13. Pregnancy or breastfeeding\n14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.",{"count":171,"type":21},38,[123],"This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.",[126],"2023-03-09",{"date":177,"type":32},"2023-03-13",{"date":159,"type":21},{"date":180,"type":21},"2026-12",{"name":38,"class":39},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100438963","phase-1-a-study-of-xzp-5955-tablets-in-patients-with-ntrk-or-ros1-fusion-positive-locally-advanced-or-metastatic-solid-tumors-100438963","NCT04996121","A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors","The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Male or female subjects aged ≥18 years old;\n2. Phase I dose escalation period: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, assessed by investigator that no standard therapy exists, or the tumor has relapsed, progressed or was nonresponsive to available therapies, or intolerance, or not suitable to standard therapy at current stage. Priority will be given to patients who have previously documented NTRK or ROS1 gene fusion confirmed by the central laboratory; Phase I dose expansion and Phase II: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, patients can provide a written report of pathological diagnosis of NTRK or ROS1 positive tested by qualified laboratory;\n3. Phase I dose expansion cohort 1 and Phase II cohort 1: locally advanced, or metastatic solid tumor with NTRK gene fusion Phase I dose expansion cohort 2 and Phase II cohort 2： locally advanced, or metastatic NSCLC with ROS1 gene fusion that has progressed to crizotinib and other therapies or was intolerance to crizotinib Phase I dose expansion cohort 3: locally advanced, or metastatic NSCLC with ROS1 gene fusion who have not previously received crizotinib or other therapy.\n4. phase I dose escalation: at least 1 measurable target lesion according to RECIST version 1.1 Phase I dose expansion and Phase II: at least 1 measurable target lesion according to RECIST version 1.1 (Tumor lesions treated with prior radiation or other local treatment are considered measurable if they show definite progression)\n5. ECOG PS 0-1\n6. Life expectancy ≥ 3 months.\n7. Adequate organ function:\n\n   Baseline laboratory values fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1.5 × 109\u002FL; Platelets (PLTs) ≥75 × 109\u002FL; Hemoglobin ≥ 85g\u002FL; Serum creatinine≤ 1.5 × ULN， or creatinine clearance ≥50 mL\u002Fmin\u002F1.73m2(only when serum creatinine\\>1.5 × ULN); Total serum bilirubin ≤1.5 × ULN; Liver transaminases (AST\u002FALT) ≤ 2.5 × ULN，≤3× ULN if liver metastases are present or liver cancer patients; Activated Partial Thromboplastin Time≤1.5× ULN；International Normalized Ratio (INR)≤1.5× ULN；\n8. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner during the trial and within 90 days from the last dose; Women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose of the trial.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug except the following:\n\n   Nitroso ureas or mitomycin C within 6 weeks before the first dose of the drug; Oral fluorouracil and small molecule targeted drugs within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer);\n2. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug;\n3. Major organ surgery (except biopsy) or significant trauma within 4 weeks prior to first dose of the investigational drug or required elective surgery during the trial;\n4. Adverse reactions to previous antitumor therapy have not recovered to NCI CTCAE 5.0 ≤ grade 1 (except for alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);\n5. Inability to swallow drug, or a condition that the investigator judged to severely affect gastrointestinal absorption (eg:Chronic Diarrhea, intestinal obstruction, etc.);\n6. Cerebral or meningeal metastases with clinical symptoms. The below patients were allowed to be included: those who were asymptomatic, stable, and did not require steroid treatment for more than 4 weeks prior to the start of study treatment (if the cerebral metastases had undergone radiotherapy or\u002Fand surgery, radiotherapy and surgery should be at least 1 month prior to the first dose) ;\n7. Known active infections and currently need intravenous anti-infective therapy;\n8. History of immune deficiencies, including positive HIV antibody tests;\n9. Active Hepatitis B (HBsAg and\u002For HBcAb positive with HBV-DNA \\> 500IU\u002Fml) or hepatitis c virus infection (positive test results of anti-HCV with positive HCV-RNA );\n10. Known interstitial lung disease (except for radioactive pulmonary fibrosis that does not require steroid therapy);\n11. History of serious cardiovascular disease;\n12. Pregnant or lactating women.",{"count":190,"type":21},360,[123,192],"PHASE2","A phase I\u002FII study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion",[195,196],"Locally Advanced or Metastatic Solid Tumors","Locally Advanced or Metastatic Non-small Cell Lung Cancer",[198,199,200],"XZP-5955","Safety, tolerability, pharmacokinetics and efficacy","Solid tumors with NTRK or ROS1 gene fusion","2022-08-28",{"date":203,"type":32},"2022-08-30",{"date":205,"type":32},"2021-12-06",{"date":207,"type":21},"2027-06",{"name":38,"class":39},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":40},"100463913","phase-1-a-study-of-km257-in-patients-with-advanced-her2-positive-or-expressing-solid-tumors-100463913","NCT05320874","A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.","The Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors in a Single-arm, Open-label, Multi-center Phase 1 Clinical Study.","Inclusion Criteria:\n\n1. Able to understand, voluntarily participate and willing to sign the ICF.\n2. Male or female subject \\>= 18 years and =\\\u003C75 years.\n3. Histologically or cytologically confirmed advanced solid tumors.\n4. HER2 positive or expressing.\n5. ECOG score 0 or 1.\n6. According to the definition of RECIST1.1, for Part1a, the patient has evaluable but Non-measurable lesion can be accepted. For Part1b, the patient has at least one measurable lesion.\n7. Life expectancy≥12weeks.\n8. Adequate organ function.\n9. Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.\n\nExclusion Criteria:\n\n1. primary CNS tumors (including meningeal tumors), symptomatic or untreated CNS metastases(including meningeal metastases).\n2. Subjects who had other malignancies in the 2 years prior to the first administration of the investigational drug were excluded in Phase Ib, except those who had basal cell carcinoma, breast cancer in situ, or cervical cancer in situ and had no recurrence and metastasis after radical therapy.\n3. Accepted any other anti-tumor drug therapies within 2 weeks before first dose.\n4. Accepted major surgery or radical radiotherapy within 4 weeks before first dose; Accepted palliative radiotherapy within 2 weeks before first dose; Accepted radioactive agents(strontium, samarium, etc.)for therapeutic purposes within 8 weeks before first dose.\n5. Participating in other studies involving investigational drug(s) ≤ 4 weeks before the first dose of KM257.\n6. Subjects with interstitial lung disease or non-infectious pneumonia and related history.\n7. Infection with HIV disease.\n8. Active hepatitis.\n9. Had an active infection requiring systemic treatment within 2 weeks prior to initial administration of the investigational drug.\n10. Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled.\n\n    Subjects are eligible with clinically controlled and stable neurologic function \\>= 4 weeks, which is no evidence of CNS disease progression; Subjects with\n11. Subjects who have received organ transplants.\n12. Unresolved toxicities ( Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade greater than or equal to2) from prior anti-cancer therapy. (with the exception of alopecia, the special provisions of inclusion criteria);\n13. Subjects who have a history of severe allergic reactions to antibody medications or have a history of severe allergic asthma (CTCAE V5.0 grade ≥3).\n14. Subjects with a known history of alcohol or drug abuse.\n15. History of myocardial infarction or unstable angina within 6 months prior to enrollment, congestive heart failure (NYHA Class≥2), or clinically significant cardiac disease，LVEF\\\u003C50%，QTc Fridericia (QTcF) \\> 470 ms for female, QTc Fridericia (QTcF) \\> 450 ms for male.\n16. History of TIA or stroke within 6 months prior to initial administration of KM257.\n17. Subjects known to have a mental illness that may affect trial compliance.\n18. The investigator considers that the subject has any clinical or laboratory abnormalities or other reasons that would disqualify him or her from participating in this clinical study.\n19. Part1b cohort 2: subjects with known mutations in exons 2, 3, and 4 of KRAS\u002FNRAS and in V600E of BRAF.",{"count":217,"type":21},232,[123],"This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing cancers.",[126],[222,199,223],"KM257","Advanced HER2 positive or expressing solid tumors","2022-04-08",{"date":226,"type":32},"2022-04-11",{"date":228,"type":21},"2022-04",{"date":230,"type":21},"2026-11",{"name":38,"class":39},""]