[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Henan Genuine Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":139},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,71,92,114],{"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":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100620847","phase-1-a-phase-a-clinical-study-of-gen-725-in-combination-with-dositinib-100620847",false,"NCT07362940","A Phase Ⅰ\u002FⅡa Clinical Study of GEN-725 in Combination With Dositinib","A Phase Ⅰ\u002FⅡa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. 18-75 years old (including 18 and 75 years old), male or female.\n2. Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to curative surgery or radiotherapy. (For subjects naive to EGFR-TKI therapy, paraffin-embedded tissue blocks, unstained slides, or fresh tumor tissue samples must be available for EGFR testing.)\n3. Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are recommended.)\n4. a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed). Patients who have received prior neoadjuvant, adjuvant, and\u002For radical concurrent\u002Fsequential chemoradiotherapy (including chemotherapy, immunotherapy, targeted therapy, etc.) must have documented disease recurrence or progression within \\\u003C6 months of completing the last regimen. b) Phase Ⅱa Dose Expansion Stage: Cohort 1: NSCLC patients with disease progression on a prior third-generation EGFR-TKI. Cohort 2: EGFR mutant NSCLC patients who are EGFR-TKI-naive.\n5. Patients with at least one measurable or evaluable lesion per RECIST 1.1 criteria.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a life expectancy of at least 12 weeks.\n7. Adequate organ function must meet the following criteria (with no transfusion of blood, blood products, no administration of hematopoietic growth factors, or no infusion of albumin\u002Fblood products within 14 days before laboratory testing):\n\n   1. Absolute neutrophil (NE) count ≥ 1.5 × 10\\^9\u002FL.\n   2. Platelet (PLT) count ≥ 100 × 10\\^9\u002FL.\n   3. Hemoglobin (HGB) ≥ 100 g\u002FL.\n   4. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBIL ≤ 3 × ULN and AST\u002FALT ≤ 5 × ULN are acceptable).\n   5. Serum creatinine (SCr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin. Note: If the investigator deems retesting necessary (with the reason documented), the above laboratory tests may be repeated only once. If the retesting results meet the criteria, they will be considered eligible.\n8. Patients with stable intracranial metastatic lesions are eligible. Stable intracranial metastasis is defined as: stable signs and symptoms for at least 2 weeks before enrollment, and discontinuation of corticosteroid treatment for intracranial metastasis for at least 14 days before enrollment. Patients with stable intracranial metastases (including newly identified intracranial metastasis that are treatment-naive) who do not require treatment are eligible. Patients with stable meningeal metastasis are eligible following confirmation by the investigator (Applicable only to dose expansion stage).\n9. Women of childbearing potential must have a negative blood pregnancy test and agree to use effective contraception during the study treatment and for 180 days after the last administration. According to the judgment of the investigator, women of childbearing potential in this study are defined as sexually mature women: 1) have not undergone a hysterectomy or bilateral oophorectomy; 2) have not experienced natural menopause last for 12 consecutive months (amenorrhea following cancer treatment does not preclude the possibility of fertility) (i.e., have experienced menstruation with the last 12 consecutive months). Male patients with female partners of childbearing potential must agree to use effective contraception during the study treatment and for 180 days after the last administration.\n10. Subjects have been fully informed, have voluntarily sign the informed consent form, and are willing to comply with the study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Patients have previously received any of the following treatments:\n\n   1. Undergone major surgery within 4 weeks prior to the first administration;\n   2. Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration; for oral small-molecule targeted drugs, within 2 weeks or within 5 half-lives prior to the first administration (whichever is shorter);\n   3. Radiation therapy involving \\>30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration;\n   4. Strong inhibitors or inducers of CYP3A4 within 7 days prior to the first administration;\n   5. Traditional Chinese medicine (TCM) or TCM preparations that have antitumor indications, or that are intended for tumor adjuvant therapy within 14 days prior to the first administration;\n2. Presence of unresolved toxicities from previous anticancer therapy, with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade \\>1 (except alopecia) at the start of study treatment. The pre-existing neuropathy from previous platinum-therapy is allowed up to grade 2;\n3. Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: MET exon 14 skipping mutation, MET amplification, ALK fusion, HER-2 mutation, ROS-1 fusion, RET fusion, BRAF V600E mutation, KRAS G12C, NTRK fusion, etc. (Applicable only to the dose expansion period, and will be adjusted according to the gene detection results from the dose escalation period);\n4. Patients with disease progression (PD) or stable disease (SD) with a duration of ≤3 months following treatment with a third-generation EGFR-TKI;\n5. Patients with any uncontrolled systemic disease, as determined by the investigator, such as uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after optimal medical therapy), uncontrolled diabetes, coronary artery stenosis, aortic dissection, aortic aneurysm, active bleeding diathesis, etc.;\n6. Patients with any clinically significant gastrointestinal condition that could impair the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrollable nausea and vomiting, history of major gastrointestinal resection, uncured chronic diarrhea, atrophic gastritis (age of onset \\\u003C60 years), uncured gastric diseases requiring long-term use of proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole), Crohn's disease, ulcerative colitis, etc.;\n7. Patients meeting any of the following cardiac criteria:\n\n   1. Mean corrected QT interval (QTc) \\>470 msec based on resting electrocardiogram (ECG);\n   2. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG, such as complete left bundle branch block, Ⅲ degree atrioventricular block, Ⅱ degree atrioventricular block, or PR interval \\>250 msec, etc.;\n   3. Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or poorly controlled and clinically significant arrhythmias;\n   4. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome in first-degree relatives or unexplained sudden death under 40 years of age, or current use of any medication known to prolong the QT interval;\n8. Left ventricular ejection fraction (LVEF) \\\u003C50% as measured by echocardiography;\n9. Patients with interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; or those with suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging during screening;\n10. Patients with concurrent pulmonary disease resulting in clinically severe respiratory impairment, including but not limited to: severe pulmonary embolism within 3 months prior to the first dose, severe asthma, or severe chronic obstructive pulmonary disease, etc.;\n11. Patients with a history of significant arterial\u002Fvenous thrombotic events or cerebrovascular accidents within 6 months prior to the first administration, such as pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc.; with the exception of asymptomatic lacunar infarction or intramuscular venous thrombosis not requiring clinical intervention;\n12. Patients with concurrent use of therapeutic doses of anticoagulants such as vitamin K antagonists or heparin (patients using prophylactic doses are eligible);\n13. Patients with an active systemic infection: Tuberculosis (clinical diagnosis including history, physical examination, radiographic findings, and TB testing per local practice), Hepatitis B (HBsAg positive and HBV DNA ≥500 copies\u002Fml or above the upper limit of the normal reference range), Hepatitis C (HCV RNA above the upper limit of normal), or Human Immunodeficiency Virus (HIV antibody positive);\n14. Patients with clinically uncontrolled pleural effusion\u002Fascites\u002Fpericardial effusion within 2 weeks prior to the first administration. (Patients are eligible if the effusion does not require drainage or has shown no significant increase for 3 days after drainage cessation);\n15. Patients with a history of other malignancies within 5 years prior to the first administration, except for: adequately treated papillary thyroid carcinoma, basal cell or squamous cell skin cancer, or other in situ carcinomas that have been adequately treated with no evidence of recurrence (including but not limited to cervical carcinoma in situ, ductal carcinoma in situ of the breast, etc.);\n16. Patients who have received systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks prior to the first administration. The use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is permitted;\n17. Patients with a history of psychiatric disorders or substance abuse that may impair compliance with trial requirements;\n18. Patients with a history of other acquired or congenital immunodeficiency diseases, or those who have undergone or are scheduled for organ transplantation or bone marrow transplantation;\n19. Patients with a history of hypersensitivity to the active ingredient or any excipients of the study drug, or to any drug of a similar chemical structures or pharmacological class;\n20. Patients with any other acute or chronic medical conditions, psychiatric conditions, or abnormal laboratory findings that may increase the risk associated with study participation or study drug administration, or interfere with result interpretation, and, in the investigator's judgment, make the patients unsuitable for participation in this study;\n21. Patients who are unlikely to comply with the study protocol, or in the investigator's opinion, the patient is unsuitable for participation in this clinical study due to other reason.","ALL","18 Years","75 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an open-label phase I\u002Fphase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or metastatic EGFR-mutant non-small cell lung cancer.",[28],"Non-Small Cell Lung Cancer",[28,30,31,32],"EGFR mutation","GEN -725","Dositinib","RECRUITING","2026-01-15",{"date":36,"type":37},"2026-01-23","ACTUAL",{"date":39,"type":37},"2025-11-27",{"date":41,"type":21},"2028-12-31",{"name":43,"class":44},"Henan Genuine Biotech Co., Ltd.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100616682","phase-2-a-phase-a-clinical-study-of-cl-197-capsules-100616682","NCT07308782","A Phase Ⅱa Clinical Study of CL-197 Capsules","An Exploratory Pharmacodynamic Clinical Study of CL-197 Capsules in Treatment Naive Patients With Human Immunodeficiency Virus (HIV-1)","Inclusion Criteria:\n\n1. Participants aged 18-60 (including boundary values), both male and female.\n2. Body mass index (BMI) range between 18.5-29.9 (including the boundary value). Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women.\n3. Participants diagnosed with HIV-1 infection before screening, and never received any anti-HIV drugs or HIV-related vaccine therapy (including investigational or other unmarketed anti-HIV drugs or vaccines) before screening.\n4. Participants who agree not to receive other anti-HIV drugs during the trial period (from signing the informed consent form until the Day 13 sampling).\n5. CD4 cell count \\> 200 cells\u002FμL at screening.\n6. Women of childbearing potential (WOCBP) must have adopted effective non-drug contraceptive measures, have a negative serum pregnancy test at screening\u002Fbaseline, and be willing to use appropriate effective methods of contraception from signing the informed consent form until 3 months after the last dose of the study drug. Male study participants must be willing to refrain from fathering children and voluntarily use effective contraception during the trial and until 3 months after the last dose of the study drug, or have been surgically sterilized.\n7. Participants who understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months prior to enrollment with the condition remaining unstable within 4 weeks prior to enrollment.\n2. Had pre-exposure prophylaxis (PrEP) and\u002For post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.\n3. Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine\u002Fmetabolic, neurological\u002Fpsychiatric, hematological, and immune system diseases, etc.) that is poorly controlled, as determined by the investigator at screening.\n4. Resting systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg, or heart rate \\> 100 beats per minute, or heart rate \\\u003C 50 beats per minute, or QTcF (QT interval corrected for heart rate according to Fridericia's formula) \\> 450 ms, or fasting blood glucose ≥ 7.0 mmol\u002FL.\n5. History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug components (e.g., lactose or gelatin), or food, or history of allergic diseases requiring medication control (e.g., asthma, urticaria, atopic dermatitis\u002Feczema, etc.) prior to screening.\n6. Had major gastrointestinal surgery within 6 months prior to screening (except uncomplicated appendectomy or cholecystectomy), or any surgery that could affect drug absorption, distribution, metabolism and excretion; or planned elective surgery during the trial period, as determined by the investigator at screening.\n7. History of malignancy (except carcinoma in situ of the cervix treated with conization, or radically resected basal cell carcinoma, squamous cell carcinoma, and\u002For carcinoma in situ \\[Bowen's disease\\] of the skin).\n8. Hepatitis B surface antigen (HBsAg) positive at screening, or active syphilis, or Hepatitis C virus (HCV) antibody positive, or previous interferon treatment for HBV infection leading to HBsAg seroconversion.\n9. Hemoglobin (Hb) \\\u003C 110 g\u002FL, or white blood cell (WBC) count \\\u003C 3 × 10\\^9\u002FL, or absolute neutrophil count (ANC) \\\u003C 1 × 10\\^9\u002FL, or platelet (PLT) count \\\u003C 100 × 10\\^9\u002FL at screening.\n10. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≥ 2.5 times upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.5 × ULN at screening.\n11. Serum creatinine (SCr) \\> 1.1 × ULN, or creatinine clearance (Ccr) \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) at screening.\n12. Participants smoke more than 5 cigarettes daily on average within 3 months prior to screening, or may be unwilling to stop using any tobacco products during drug administration and sampling periods.\n13. Drinking more than 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer with 5% alcohol, or 45 mL of liquor with 40% alcohol, or 150 mL of wine with 12% alcohol) within 3 months prior to screening on average, or positive alcohol breath test at screening or baseline, or unwillingness to stop using any alcohol-containing products during hospitalization.\n14. Excessive consumption of tea, coffee, and\u002For caffeine-containing beverages (averaging more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to screening on average, or unwillingness to stop consuming tea, coffee, and\u002For caffeine-containing beverages during hospitalization.\n15. Participants with consumption of pitaya, mango, pomelo, carambola, or foods\u002Fbeverages prepared from them, or foods\u002Fbeverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or any other special diet that may affect drug absorption, distribution, metabolism, or excretion within 48 hours prior to the first dose of the investigational product, or unwillingness to stop using them during hospitalization.\n16. History of drug abuse (non-medical, excessive, misuse, or addictive use of any drug leading to social, psychological, or physical impairment) within 5 years prior to screening, or positive urine drug screen at screening or baseline.\n17. Intolerance to venipuncture, or history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or blood transfusion within 3 months prior to screening, or blood donation plan during the trial.\n18. Specific dietary requirements during the trial, or inability to accept the standardized diet.\n19. Have participated in or are participating in other investigational drug or interventional medical device clinical trials (having signed informed consent and received investigational drug\u002Finterventional device or placebo) within 3 months prior to screening.\n20. Pregnant or breastfeeding females at screening, or positive serum pregnancy test (applicable to WOCBP only).\n21. Have a birth plan (including egg or sperm donation) by WOCBP or male participants from 1 month prior to informed consent until 3 months after administration of the investigational drug, or unwillingness to use effective contraception\u002Fbarrier methods (including one or more non-drug contraceptive methods or abstinence from heterosexual activity).\n22. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within 14 days prior to dosing.\n23. Any other conditions considered by the investigator as unsuitable for participation in this trial.","60 Years",{"count":54,"type":21},24,[25],"This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.",[58],"HIV-1 Infection",[60,61],"HIV-1 infection","CL-197","2026-01-05",{"date":64,"type":37},"2026-01-06",{"date":66,"type":37},"2025-11-29",{"date":68,"type":21},"2027-03",{"name":43,"class":44},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":5},"100610706","phase-1-a-dose-escalation-and-dose-expansion-phase-iphase-ii-clinical-study-of-dositinib-mesylate-tablets-90-1408-in-the-treatment-of-locally-advanced-or-metastatic-non-small-cell-lung-cancer-with-positive-egfr-mutation-100610706","NCT07231068","A Dose-escalation and Dose-expansion Phase I\u002FPhase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation","A Dose-escalation and Dose-expansion Phase I\u002FPhase II Clinical Study on the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutations","Inclusion Criteria:\n\n1. 18-75 years old (including 18 and 75 years old), male or female.\n2. Histologically or cytologically confirmed patients with locally advanced NSCLC (stage IIIB \u002F IIIc) or metastatic NSCLC (stage IV) who are unable to undergo radical surgery or radiotherapy (International Alliance against cancer, 8th Edition, 2017).\n3. Locally advanced or metastatic NSCLC patients who have documentation of disease progression (with imaging evidence) while on previous continuous treatments with EGFR-TKI (such as gefitinib, erlotinib, icotinib, afatinib, etc., excluding the third-generation EGFR TKI drugs), or cannot tolerate the treatments for various reasons (only applicable to dose escalation part).\n4. Patients with confirmed EGFR activating mutations that are sensitive to EGFR TKI at any time after initial diagnosis, in dose escalation part including G719X, exon 19 deletion, L858R, L861Q, in dose expansion part including exon 19 deletion and L858R.\n5. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC (patients who have received first-line chemotherapy but not TKI treatment can be enrolled). Patients who have undergone radical surgery, radical chemoradiotherapy or adjuvant treatment (chemotherapy, radiotherapy) for early-stage NSCLC and have experienced disease recurrence or metastasis later can be enrolled (only applicable to dose expansion part).\n6. According to RECIST 1.1 response evaluation criteria in solid tumours, the patient has at least one imaging (CT, MRI) measurable or evaluable lesion, and accurate and repeatable measurement can be made at baseline, such as CT or MRI. In the dose expansion part, for the 160 mg and 200 mg dose groups, at least one measurable intracranial lesion is required in 20 to 30 patients with brain metastases. The long diameter of the lesion is more than or equal to 10 mm (if the lesion is a metastatic lymph node, the short diameter is more than or equal to 15 mm), and the lesion has not received radiotherapy or biopsy in the past (if the patient has only one target lesion and needs biopsy, the target lesion can be biopsied, and the time interval between the biopsy and the baseline assessment of the tumor in the screening period must be more than 2 weeks, and the target lesion still meets the definition in RECIST1.1 after biopsy). The same test method should be used in the follow-up evaluations.\n7. Subjects with ECOG performance score of 0-1.\n8. Patients whose life expectancy is at least 12 weeks.\n9. Patients have adequate important organ functions during screening, including: a. The absolute neutrophil count (NEUT#) ≥ 1.5 x 10\\^9\u002FL without using hematopoietic stimulating factor within 14 days before the first administration; b. Platelet count ≥ 100 x 10\\^9 \u002F L without using hematopoietic stimulating factor or blood transfusion within 14 days before the first administration; c. Hemoglobin\\>90g\u002FL without using hematopoietic stimulating factor or blood transfusion within 14 days before the first administration; d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN (ULN = upper limit of normal value) or ≤ 5 x ULN (patients with hepatic metastases); e. Total bilirubin ≤1.5 x ULN (ULN = upper limit of normal value) or ≤ 3 x ULN (patients with hepatic metastase); f. Coagulation function INR ≤ 1.5; g. Serum creatinine ≤ 1.5 x ULN (ULN = upper limit of normal value) and creatinine clearance rate (calculated by Cockcroft and Gault formula) ≥ 50ml \u002F min.\n10. Female subjects of childbearing age must confirm that the blood pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 90 days after the last administration.\n\n    In this program, female subjects of childbearing age are defined as sexually mature women. (1) No hysterectomy or bilateral oophorectomy is performed; (2) Natural amenorrhea doesn't last for 12 consecutive months (amenorrhea after cancer treatment does not exclude fertility) (i.e., menstruation occurred at any time in the previous 12 consecutive months); if the female partner of a male subject is fertile, the subject must agree to take adequate contraceptive measures from the first administration of the study treatment to 90 days after the last administration of the study treatment.\n11. The subjects should give informed consent to the study and sign the informed consent form before the trial.\n\nExclusion Criteria:\n\n1. Within 28 days before the first administration of the study treatment, the patients have used any chemotherapy drugs and \u002F or immunotherapy drugs in the previous treatment regimen or clinical study; or have undergone major surgery (excluding vascular access establishment surgery) or received \\> 30Gy within 28 days before the first administration of the study treatment. In addition to the local palliative radiotherapy for bone metastases, the patient have used an experimental drug or other anticancer drugs in the previous treatment regimen or clinical study within 14 days before the first administration of the study treatment, or stopped using other experimental drugs or anticancer drugs for less than 5 ×half-life (e.g., erlotinib less than 8 days, gefitinib less than 10 days, icotinib less than 2 days, afatinib less than 8 days).\n2. Patients who have used the third generation EGFR TKI drugs (such as Osimertinib, rociletinib (co-1686), olmutinib (hm61713), asp8273, egf816, Mefatinib, Avitinib, etc.).\n3. Patients who participated in other therapeutic clinical trials within one month before the first administration (patients who discontinue the experimental drug after more than five half-lives of the drug can be included in the study).\n4. The patients are using (or cannot stop using) CYP3A4 strong inhibitor or inducer or Chinese herbal medicine with anti-tumor indications.\n5. Patients who did not recover from the adverse events caused by previous anti-tumor therapy (recovered to ≤ 1 grade) (except for alopecia).\n6. Patients with other malignant tumors within 5 years before the start of treatment (except for basal cell carcinoma or squamous cell carcinoma of the skin that is not melanoma, breast \u002F cervical carcinoma in situ, superficial bladder carcinoma and other carcinoma in situ who have received radical treatment and no evidence of recurrence).\n7. Any condition that affects the patients' swallowing of the drug and seriously affects the absorption or pharmacokinetic parameters of the investigational drug, including any kind of uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability of the patient to swallow the drug, history of gastrointestinal resection or surgery.\n8. Patients with known organ transplantation.\n9. Meet any of the following cardiac criteria: QTc interval \\> 450ms in male and \\> 470ms in female (QTc interval calculated by fridericia formula). All kinds of ECG morphological abnormalities with clinical significance, such as complete left bundle branch block, grade III block, grade II block, PR interval \\> 250ms. Various factors that may increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of immediate family members with long QT syndrome or unexplained sudden death before 40 years of age, and the use of any drug with known QT interval prolongation.\n10. Past medical history: interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, active interstitial lung disease with clinical evidence; patients with active pulmonary tuberculosis (TB) who are receiving anti tuberculosis treatment or received anti tuberculosis treatment within one year before screening.\n11. Pulmonary function test: forced expiratory volume in one second (FEV1) \u002F forced vital capacity (FVC) \\\u003C 70%, FEV1% \\\u003C 30%, or DLCO% \\\u003C 40%.\n12. Patients with spinal cord compression, or meningeal metastasis, or symptomatic and untreated brain metastasis (except those who are asymptomatic, stable, and do not need steroid therapy for more than 4 weeks before the start of study treatment).\n13. The patients have a history of hypersensitivity to the active ingredients or inactive excipients of the study drug, drugs with chemical structure similar to the study drug or similar drugs, etc.).\n14. At any time after the initial diagnosis, there are confirmed EGFR 20 exon insertion mutations.\n15. Subjects are in the stage of acute infection and need medical treatment.\n16. In the active stage of hepatitis B or hepatitis C: HBsAg positive and HBV DNA ≥ 10\\^3 copies\u002FmL or ≥ 200 IU\u002FmL (HBV DNA is required when HBsAg is positive), HCVAb positive and HCV-RNA ≥ 10\\^3 copies\u002FmL (HCV-RNA is required when HCVAb is positive).\n17. Subjects are HIV positive.\n18. Subjects with a clear history of mental disorders and who have taken medication for treatment\n19. Subjects have a history of drug abuse.\n20. Pregnant or lactating women.\n21. Women of childbearing age and fertile men can not take effective contraceptive measures during the period from signing the informed consent to 90 days after the last use of the study drug.\n22. The researcher believes that there are other factors that may affect the results of the study and interfere with the whole process of the study, including past or existing physical conditions, treatment or laboratory abnormalities, etc.; or the researcher believes that participating in the study can not maximize the benefits of the patients.\n23. Subjects are not suitable to participate in this study for any reason in the judgment of the researcher.",{"count":79,"type":21},153,[24,25],"This is an open label phase I\u002Fphase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.",[28],[28,30,32],"2025-11-13",{"date":86,"type":37},"2025-11-17",{"date":88,"type":37},"2022-10-31",{"date":90,"type":21},"2029-12-31",{"name":43,"class":44},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100610616","phase-1-a-phase--clinical-study-of-gen-725-tablets-in-patients-with-advanced-solid-tumors-100610616","NCT07229898","A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors","A Phase Ⅰ Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GEN-725 Tablets in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form (ICF).\n2. Aged ≥ 18 years and ≤ 75 years, regardless of gender.\n3. Subjects must meet the following criteria:\n\n   a) Diagnosed by histology or cytology with advanced solid tumors that have progressed after standard treatment, are intolerant to standard treatment, have no standard treatment available, or are judged by the investigator as unsuitable for standard treatment. Tumor types include but are not limited to: NSCLC, HCC, CRC, bladder cancer, breast cancer, etc.; AND b) Time since prior anti-PD-1\u002FPD-L1 monoclonal antibody monotherapy or combination therapy to recurrence\u002Fprogression is ≥ 6 months.\n4. Presence of at least one measurable lesion (RECIST v1.1 criteria).\n5. ECOG performance status score of 0 or 1.\n6. For HCC patients, must have Child-Pugh class A or B, without hepatic encephalopathy.\n7. Expected survival time ≥ 3 months.\n8. Toxicities from prior treatments (except for alopecia and pigmentation) have all recovered to Grade 1 or normal levels.\n9. Adequate organ function, meeting all of the following laboratory test results prior to enrollment:\n\n   * Hematology: ANC ≥ 1.5×10\\^9\u002FL, platelet count ≥ 75×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL;\n   * Liver function: Serum bilirubin ≤ 1.5×upper limit of normal (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5×ULN, or if liver metastases are present, AST and ALT ≤ 5×ULN;\n   * Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n   * Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;\n   * Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n10. Subjects with reproductive potential (including spouses of male subjects) have no plan for pregnancy or sperm donation from screening until 6 months after the last dose, and are willing to use at least one effective contraception method.\n\nExclusion Criteria:\n\n1. Subjects with a history of allergic reactions to GEN-725 tablets or to active or inactive excipients of drugs with similar chemical structures or of the same class.\n2. Subjects who meet any of the following criteria:\n\n   Have received systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug;\n\n   Have received hormonal anti-tumor therapy, small molecule targeted therapy, oral fluorouracil drugs, or endocrine therapy within 2 weeks prior to the first dose of the investigational drug;\n\n   Have undergone palliative local therapy for non-target lesions within 2 weeks prior to the first dose of the investigational drug;\n\n   Have received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 4 weeks prior to the first dose of the investigational drug;\n\n   Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.\n3. Subjects who have received anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug, or who plan to receive such vaccines during the study period.\n4. Subjects who have received systemic therapy with corticosteroids (\\> 10 mg\u002Fday of dexamethasone or equivalent dose) or other immunosuppressive drugs within 4 weeks prior to the first dose of the investigational drug. However, topical applications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted, provided the dosage does not exceed the recommended dose in the prescribing information and there are no signs of systemic exposure.\n5. Subjects with a history of acute or chronic pancreatitis.\n6. Subjects with brain metastases and\u002For carcinomatous meningitis (except for those with brain metastases that have been adequately treated, have remained stable for at least 3 months prior to screening, have all neurological symptoms returned to baseline levels, show no evidence of new or enlarging metastases, and have ceased radiotherapy, surgery, or steroid therapy for at least 4 weeks prior to the first dose of the investigational drug).\n7. Subjects with spinal cord compression that has not been radically treated by surgery and\u002For radiotherapy.\n8. Subjects with a history or evidence of significant cardiovascular disease within 6 months prior to screening, including but not limited to:\n\n   History of myocardial infarction, coronary angioplasty or bypass grafting, valvular heart disease or valvular repair, clinically significant arrhythmias requiring treatment, unstable angina, transient ischemic attack, cerebrovascular accident, etc.;\n\n   Congestive heart failure classified as Class III or IV according to the New York Heart Association (NYHA) criteria.\n9. Subjects with clinically significant abnormalities in the 12-ECG examination during screening, including but not limited to severe arrhythmias, prolonged QT interval (QTcF: \\> 450 ms for males, \\> 470 ms for females; QTc interval calculated using Fridericia's formula); or the presence of any condition that may increase the risk of QT prolongation, such as a known history of QTc prolongation, congenital long QT syndrome, Brugada syndrome, torsades de pointes, uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypokalemia, hypomagnesemia, etc.).\n10. Subjects with hypertension uncontrolled by antihypertensive medication (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg).\n11. Subjects with presence of persistent or active infection that remains poorly controlled despite medication, including but not limited to:\n\n    Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantification ≥ the upper limit of normal (ULN);\n\n    Hepatitis C virus antibody (HCV-Ab) positive and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN;\n\n    Note: HBV-DNA testing is required only for HBsAg positive subjects; HCV-RNA testing is required only for HCV-Ab positive subjects.\n12. Subjects with existing autoimmune diseases or related symptoms, or a history of autoimmune diseases, immunodeficiency diseases (e.g., leukemia, HIV, etc.), or a history of organ transplantation.\n13. Subjects with active, uncontrolled systemic infection (e.g., bacterial, viral, or fungal) despite optimal therapy.\n14. Subjects with a history of or current interstitial lung disease, pulmonary fibrosis, drug-induced interstitial pneumonia, or radiation pneumonitis requiring steroid treatment.\n15. Subjects with moderate to large pleural effusion, pericardial effusion, or ascites requiring pharmacological or medical intervention.\n16. Subjects who have had other malignancies ( except radically cured basal cell carcinoma of the skin, squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, etc.) within 5 years prior to the first dose of the investigational drug, except for the tumor being treated in this study.\n17. Subjects who have undergone major surgery within 3 months prior to screening and have not fully recovered, or who plan to undergo major surgery during participation in this study (except for outpatient surgeries judged by the investigator to have no impact on subject safety or trial outcomes).\n18. Subjects with uncontrollable nausea, vomiting, inability to swallow normally, or those with chronic gastrointestinal diseases, gastrointestinal obstruction, or other conditions that may affect the administration and absorption of the investigational drug.\n19. Subjects with a documented history of psychiatric disorders, or a history of psychotropic drug abuse, drug abuse, or alcohol abuse.\n20. Women who are pregnant or breastfeeding.\n21. Subjects who have participated in any other drug clinical trial or are receiving other investigational therapies within 4 weeks prior to the first dose of the investigational drug (or within 5 half-lives of another investigational drug, whichever is longer) (except for patients participating only in the overall survival follow-up phase of a study).\n22. Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.",{"count":100,"type":21},48,[24],"A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.",[104],"Advanced Solid Tumors",[104,106],"GEN-725",{"date":86,"type":37},{"date":109,"type":37},"2025-01-07",{"date":111,"type":21},"2026-12-31",{"name":43,"class":44},4,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":70},"100593053","phase-1-a-pharmacokinetics-and-safety-study-of-azvudine-tablets-in-subjects-with-mild-to-moderate-gfr-decline-in-renal-insufficiency-and-in-healthy-subjects-100593053","NCT07001436","A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects","A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects","Inclusion Criteria:\n\n(一) Renal insufficiency study participants and healthy study participants:\n\n1. Age ≥ 18 years old and ≤ 70 years old, regardless of gender;\n2. Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) \u002F height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;\n3. Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;\n4. Understand and sign the informed consent form.\n\n(二) Health study participants (in addition to the above criteria, they should also meet):\n\n1. The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;\n2. Those who have not taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before screening;\n3. Meet the classification standard of glomerular filtration rate of 90≤GFR\\\u003C130 ml\u002Fmin;\n4. Study participants with mild or moderate decline in GFR were matched with the following demographic characteristics: age (mean ± 10 years), weight (mean ±10kg), and gender (±1 cases).\n\n(三) Renal insufficiency study participants (in addition to the above criteria, they should also meet):\n\n1. Stable renal function status: the existing renal function impairment is required to last for more than 3 months, and the GFR results of two tests (with an interval of 72 hours or more) during the screening period are within the same grade and the difference between the two tests is not more than 25%;\n2. No clinically significant abnormalities were found in the pre-test medical history, vital signs, physical examination, laboratory test items (except ALT and AST, total bilirubin, and direct bilirubin) and test-related examinations and were judged by the clinical research physician to be eligible for enrollment (except for abnormalities related to renal impairment);\n3. The drug being taken by the study participant with renal insufficiency, which should not affect the absorption, distribution, metabolism or excretion of the study drug, and has been taken at a stable dose for at least 4 consecutive weeks before giving the study drug, and agrees to continue treatment during the study period;\n4. Two weeks before administration and during the test, Chinese patent medicines, traditional Chinese medicine decoctions, ethnic medicines, SGLT-2i, MRA drugs and benzbromarone are prohibited;\n5. During the screening period, it is necessary to meet: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) all need to \\\u003C 1.5 upper limit of normal (ULN)\n6. Participants in the study of renal insufficiency of all grades met the grading criteria for glomerular filtration rate (GFR was taken as the average of the two tests during the screening period): Mild decrease in GFR: 60≤ GFR≤89 ml\u002Fmin; Moderate decrease in GFR: 30≤GFR ≤59 ml\u002Fmin.\n\nExclusion Criteria:\n\n(一) Renal insufficiency and health research participants:\n\n1. Allergies, especially those who are allergic to any of the ingredients in this product and excipients;\n2. Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;\n3. Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;\n4. Those with fever or infectious diseases at the time of screening;\n5. Those who have participated in other clinical trials within 3 months before screening;\n6. Those who have a history of smoking addiction within 12 months before screening (the average number of cigarettes per day ≥5);\n7. Those who have a history of alcohol abuse within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value \\>0mg\u002F100mL) before enrollment;\n8. Those who have lost blood or donated 200mL of blood ≥ within 8 weeks before screening;\n9. Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum antibody or rapid plasma reagin ring card test (RPR) test results are positive.\n10. Pregnant and lactating women;\n11. Those who cannot tolerate vascular puncture blood collection and\u002For have a history of blood sickness, needle fainting and\u002For poor blood collection vascular conditions;\n12. Those who have been vaccinated within 3 months before screening, or plan to be vaccinated during the trial;\n13. Those who are not considered suitable to enter this trial by the investigator.\n\n(二) Renal insufficiency study participants (except for the above criteria):\n\n1. Have undergone kidney transplantation;\n2. Systolic blood pressure outside the range of 90 \\~ 160mmHg, diastolic blood pressure outside the range of 50 \\~ 100mmHg, or heart rate outside the range of 50 \\~ 120bpm;\n3. Frequent occurrence of hypoglycemia and exclusion of drug factors within 3 months prior to screening;\n4. Albumin\\\u003C30g\u002FL;\n5. Hemoglobin value\\\u003C9 g\u002FdL;\n6. Those who have a history of uncontrolled or unstable serious diseases of cardiovascular, liver, pulmonary, digestive tract, nerves, autoimmune, metabolic and musculoskeletal systems, hematopoietic systems and other systems, or those whose diseases are active.",true,"70 Years",{"count":124,"type":21},40,[24],"Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase.\n\nThis trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.",[128],"Renal Insufficiency",[130],"Azvudine","2025-05-23",{"date":133,"type":37},"2025-06-03",{"date":135,"type":37},"2025-05-20",{"date":137,"type":21},"2025-09-30",{"name":43,"class":44},""]