[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":305},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,40,62,85,110,135,165,193,212,233,258,281],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100650468","phase-3-a-study-of-the-efficacy-and-safety-of-fxs6837-capsules-compared-to-eculizumab-for-24-weeks-in-patients-with-pnh-100650468",false,"NCT07747090","A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH.","A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of FXS6837 Versus Eculizumab in Complement Inhibitor-Naïve Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion criteria:\n\n1. Male or female subjects aged ≥ 18 years at screening;\n2. Body weight ≥ 40 kg and body mass index (BMI) ≥ 18 kg\u002Fm2 at screening;\n3. Diagnosis of PNH by the investigator according to the PNH diagnostic criteria, with red blood cell and white blood cell (monocytes or neutrophil) clone levels \\> 10% detected by high sensitivity flow cytometry within 6 months before screening or during the screening period;\n4. PNH patients with no prior treatment involving any complement inhibitors;\n5. At least two measurements during the screening period (2 to 6 weeks apart) showing LDH \\> 1.5 × ULN (multiple measurements are allowed during the screening period);\n6. Hb meeting one of the following conditions: (1) Hb concentration \\\u003C 100 g\u002FL at the first screening visit, and received RBC transfusion therapy due to PNH-related anemia during the screening period; (2) Mean Hb concentration from two measurements during the screening period \\\u003C 100 g\u002FL (these two measurements should be 2 to 6 weeks apart; multiple Hb measurements are allowed during the screening period);\n\nExclusion criteria:\n\n1. With laboratory evidence of bone marrow failure during screening (reticulocyte count \\\u003C 100 × 109\u002FL, or platelet count \\\u003C 30 × 109\u002FL, or neutrophil count \\\u003C 0.5 × 109\u002FL); Received acute treatment (such as platelet transfusion, granulocyte colony-stimulating factor) for thrombocytopenia or neutropenia within 30 days before screening;\n2. Participants receiving other therapies before screening that have not reached the following stable treatment durations:\n\n   * Erythropoietin for at least 8 weeks\n   * Immunosuppressants for at least 8 weeks, systemic corticosteroids (≤ 15 mg\u002Fday) for at least 4 weeks\n   * Iron, vitamin B12, or folic acid supplementation for at least 4 weeks\n   * Anticoagulants: Vitamin K antagonists (such as warfarin) used for at least 4 weeks with a stable international normalized ratio (INR) (as determined by the investigator), low molecular weight heparin, oral anticoagulants such as aspirin, rivaroxaban, apixaban, etc., for at least 4 weeks;\n   * Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) for at least 8 weeks;\n   * Androgens for at least 4 weeks;\n3. History of malignant tumors of any organ or system within 5 years before screening (except local basal cell carcinoma of the skin or carcinoma in situ of the cervix), regardless of whether treatment was received and whether there is evidence of local recurrence or metastasis;\n4. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation (such as heart, lung, kidney, liver);\n5. History of splenectomy or planned surgery during the study period;\n6. Subjects with significantly abnormal liver function at screening: any parameter of alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), or alkaline phosphatase (ALP) \\> 3 × ULN;\n7. Human immunodeficiency virus (HIV) infection (HIV antibody positive), active syphilis infection, hepatitis B virus infection (hepatitis B surface antigen positive), active hepatitis C virus infection, or active tuberculosis infection at screening;\n8. Subjects with concurrent systemic major diseases, including but not limited to: advanced heart disease (such as New York Heart Association \\[NYHA\\] class IV), severe lung disease (such as severe pulmonary hypertension \\[WHO class IV\\]), active hepatitis, severe kidney disease (estimated glomerular filtration rate eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or chronic kidney disease \\[CKD\\] stage 4 or dialysis patients), unstable thrombosis, active gastrointestinal bleeding, other hematologic diseases (such as chronic anemia unrelated to PNH), and deemed unsuitable for study participation by the investigator;\n9. Known or suspected by investigators to have immunodeficiency diseases or hereditary complement deficiency;\n10. History of Neisseria meningitidis infection; History of ≥ 2 episodes of pneumococcal infection;\n11. Detected or suspected (as assessed by the investigator) systemic active bacterial, viral (including COVID-19), or fungal infections within 2 weeks before the first dose; Axillary temperature \\> 38 °C within 7 days before the first dose;\n12. Suspected or known history of allergies to the IPs or any ingredient in the IPs;\n13. Received any type of live attenuated vaccine within 4 weeks prior to screening, or plan to receive any live attenuated vaccine during the study;\n14. Pregnant or lactating women or those with positive pregnancy test results;\n15. Previous history of drug abuse or drug use;\n16. Participated in other clinical trials of investigational drugs (or are still within 5 half-lives of the drug, whichever is longer) or medical device clinical trials within 30 days prior to screening, plans to participate in other clinical trials during the study, or having residual effects as assessed by the investigator;","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","An open label study to evaluate the efficacy and safety of FXS6837 capsules compared to eculizumab in naive PNH patients. About 90 PNH patients who are naive to complement inhibitor therapies will be enrolled to take FXS6837 capsules or eculizumab for 24 weeks according to protocol.",[26],"Paroxysmal Nocturnal Hemoglobinuria","NOT_YET_RECRUITING","2026-08-04",{"date":30,"type":31},"2026-08-05","ACTUAL",{"date":33,"type":20},"2026-12-10",{"date":35,"type":20},"2028-07-31",{"name":37,"class":38},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100650614","phase-2-fxs6837-for-the-treatment-for-igan-patientslongterm-study-100650614","NCT07750665","FXS6837 for the Treatment for IgAN Patients（Longterm Study）","A Study to Evaluate the Long-term Efficacy and Safety of FXS6837 in IgAN Patients","Inclusion criteria: 1. Have completed the study treatment in FXS6837-IIb-201, and are evaluated by the investigator to have an anticipated benefit exceeding risk with long-term FXS6837 treatment; 2. eGFR (CKD-EPI) ≥ 30 mL\u002Fmin\u002F1.73 m2 at screening; 3. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required by the previous study (Booster vaccination should be administered promptly in accordance with vaccination guidelines and local immunization authority requirements if the vaccine protection period fails to cover the treatment duration of this study); 4. Able to continue optimized treatment with RASi, SGLT2i, ERA, and hydroxychloroquine throughout the study with stable prescribed dosing; 5. Have a detailed understanding of the nature, significance, possible benefits, potential inconveniences, and potential risks of the trial, and voluntarily participate in this clinical trial; Able to communicate well with the investigators and comply with the requirements of the entire study; And signed a written ICF; 6. Participants of reproductive potential commit to having no plans for pregnancy or sperm\u002Fegg donation from screening until 1 month (female participants) or 3 months (male participants) after the last dose and voluntarily take effective physical contraceptive methods (including partners). Exclusion criteria: 1. Known or suspected by investigators to have immunodeficiency diseases or hereditary complement deficiency; 2. Any organ transplant recipients (except corneal transplant); 3. Concomitant major systemic diseases, including but not limited to: advanced heart disease (such as NYHA class IV), severe pulmonary disease (such as severe pulmonary hypertension \\[WHO class IV\\]), active hepatitis, or other major systemic diseases assessed by investigators as unable to participate in this study; 4. History of malignant tumors within 5 years before screening (except carcinoma in situ and thyroid cancer assessed by investigators as curatively resected).\n\n5\\. Previous history of Neisseria meningitidis or recurrent Streptococcus pneumoniae infection ; 6. Suspected or known history of allergies to similar ingredients of the study drug or any ingredient in the study drug; 7. Pregnant or lactating women or those with positive pregnancy test results; 8. Other conditions deemed by the investigator that may potentially interfere with study conduct, impose additional risks to the participant, or render the individual ineligible for study participation.",{"count":48,"type":20},60,[50],"PHASE2","This is a multicenter, open-label study to evaluate the long-term safety and efficacy of FXS6837 capsules in primary IgAN patients. About 60 IgAN patients who had received and completed FXS6837-IIb-201 study treatment will be enrolled to take FXS6837 capsules orally according to protocol for 2 years.",[53],"Primary IgAN","2026-08-02",{"date":56,"type":31},"2026-08-06",{"date":58,"type":20},"2026-09-30",{"date":60,"type":20},"2030-01-04",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":39},"100646193","phase-1-qt-interval-effects-study-of-oral-fxs5626-tablets-100646193","NCT07695779","QT Interval Effects Study of Oral FXS5626 Tablets","A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of Oral FXS5626 Tablets in Healthy Chinese Participants","Inclusion Criteria：\n\n1. Healthy, adult, male or female,18-45 years of age (inclusive), with a Body Mass Index (BMI) of 19.0-28.0 kg\u002Fm2 (inclusive),have a minimum weight of at least 50kg(male) or 45kg(female).\n2. Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.\n3. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.\n4. Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm\u002Fegg donation for 3 months from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).\n\nExclusive Criteria:\n\n1. Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test\n2. Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.\n3. Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.\n4. Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years).\n5. Significant screening ECG abnormalities,QTcF interval \\> 450ms (Fridericia's correction), or QRS\\>120ms,or PR interval \\>=210ms or \\\u003C=120ms\n6. Subjects who have got severe infections within 2 months before screening; Or have a history of active bacterial infection or viral infection or fungal infection within 2 weeks before screening\n7. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.\n8. Subjects with a history of drug abuse,or who screened positive for drug abuse.\n9. Subjects who consumed more than 14 units of alcohol per week in the 6 months prior before screening (1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or had a positive alcohol breath test or could not abstain during the trial.\n10. Subjects who smoked more than 5 cigarettes per day in the 6 months prior before screening or could not give up during the trial.\n11. Subjects who have abnormal laboratory test: neutrophil count\\\u003C1.5 x10\\^9\u002FL,or white blood cell count\\\u003C3.5 x10\\^9\u002FL,or creatine kinase greater than the upper limit of normal at screening.",true,"45 Years",{"count":72,"type":20},28,[74],"PHASE1","The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.",[77],"Evaluation of QTc Interval","2026-07-06",{"date":80,"type":31},"2026-07-10",{"date":30,"type":20},{"date":83,"type":20},"2026-09-25",{"name":37,"class":38},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":39},"100640518","phase-1-phase-i-study-of-fxs0683-in-the-treatment-of-blood-tumors-100640518","NCT07616089","Phase I Study of FXS0683 in the Treatment of Blood Tumors","A Multicenter, Open, Single-arm Phase I Dose-escalation and Dose-expansion Clinical Study: Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of FXS0683 Tablets in Patients With Relapsed or Refractory Hematologic Malignancies.","FXS0683-001","Inclusion Criteria:\n\n1. Voluntary participation in the clinical trial and signing of the ICF.\n2. Age ≥ 18 years, regardless of gender.\n3. Dose escalation phase: Patients with mature B-cell malignancies diagnosed per the 2017 WHO classification who have failed standard therapies and have no appropriate treatment options. Dose expansion phase: Patients with B-cell lymphoma (2017 WHO), myeloid malignancies (2022 WHO), or acute lymphoblastic leukemia.\n4. Dose escalation phase: Evaluable disease. Dose expansion phase: For B-cell lymphoma, at least one measurable lesion per Lugano 2014 criteria.\n5. Patients must be willing to undergo bone marrow aspiration and\u002For biopsy.\n6. ECOG performance status of 0-1 (dose escalation phase) or 0-2 (dose expansion phase).\n7. Expected survival time ≥3 months.\n8. Adequate bone marrow function during screening, as defined by local laboratory reference ranges, without growth factor support.\n9. Adequate organ function, defined by laboratory values within 7 days prior to the first dose.\n10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception from signing the ICF until 6 months after the last dose.\n11. Patients at high risk of tumor lysis syndrome (TLS), defined as absolute lymphocyte count (ALC) ≥25×10⁹\u002FL with ≥1 measurable lymph node ≥5 cm or any node ≥10 cm, must be willing to comply with TLS prophylaxis and monitoring requirements.\n12. Patients must be able to comply with the study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia, plasma cell myeloma, or plasmablastic lymphoma.\n2. Acute promyelocytic leukemia (APL) or BCR-ABL positive AML patients, or patients with a history of myeloproliferative neoplasms (MPN).\n3. Use of cytotoxic agents, investigational drugs, or other antitumor therapies within 14 days or 5 half-lives prior to the first dose; or immunotherapy, antibody-based or peptide-based therapies, or live vaccines within 4 weeks prior to the first dose.\n4. Patients who received any therapeutic surgery other than diagnosis, biopsy, or drainage within 4 weeks before the first dose, or patients expected to undergo major surgery during the study. Patients who underwent drainage or placement of drainage tubes within 4 weeks before the first dose must have symptoms\u002Fsigns alleviated and not require prophylactic or therapeutic antibiotics.\n5. Patients who received systemic radiotherapy or palliative local radiotherapy within 4 weeks before the first dose.\n6. Toxicity from previous anticancer treatment has not recovered to ≤ grade 2, except for hair loss and pigmentation.\n7. Prior allogeneic stem cell transplantation; or autologous stem cell transplantation or CAR-T therapy within 3 months prior to the first dose.\n8. Patients with lymphoma\u002Fleukemia that has infiltrated the central nervous system.\n9. Patients with dysphagia or a history of severe gastrointestinal diseases and whose related symptoms cannot be reasonably controlled; or patients with gastrointestinal diseases affecting drug absorption or other malabsorption conditions.\n10. Active or clinically significant cardiovascular or cerebrovascular disease.\n11. Patients with interstitial lung disease or a history of pulmonary interstitial fibrosis; or evidence of active pneumonia found on screening chest CT scan.\n12. Patients with congenital immunodeficiency disorders or active autoimmune diseases, including but not limited to those with active and uncontrolled autoimmune cytopenias lasting ≥2 weeks, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.\n13. Patients with coagulation disorders.\n14. Patients with a history of severe allergies or allergies to any active or inactive component of the study drug.\n15. Patients with uncontrolled systemic infections within 2 weeks before the first dose; hepatitis B surface antigen positive with hepatitis B virus DNA \\>1000 IU\u002Fml; HCV antibody positive with HCV RNA positive; HIV antibody positive.\n16. Other primary malignancies within 5 years prior to enrollment, except for adequately treated basal or squamous cell skin cancer or carcinoma in situ.\n17. Patients who still require systemic immunosuppressive agents or systemic corticosteroids within 2 weeks before the study drug.\n18. Pregnant or breastfeeding women.\n19. Any other serious or uncontrolled acute or chronic disease or laboratory abnormality or other reasons deemed unsuitable for participation in this clinical trial by the investigator.",{"count":94,"type":20},228,[74],"This is a first-in-human, multicenter, open-label, single-arm Phase I study of FXS0683 in participants with relapsed or refractory hematologic malignancies to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity, and to determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D).",[98,99,100,101],"B-Cell Lymphoma","Acute Myeloid Leukemia","Myelodysplastic Syndromes","Acute Lymphoblastic Leukemia","2026-05-26",{"date":104,"type":31},"2026-05-29",{"date":106,"type":20},"2026-06-01",{"date":108,"type":20},"2029-08-08",{"name":37,"class":38},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":39},"100636199","phase-2-a-phase-2-study-of-luvometinib-combined-with-anlotinib-in-kras-mutated-nsclc-100636199","NCT07562581","A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC","A Multicenter, Open-label, Single-arm Phase 2 Study to Evaluate the Efficacy and Safety of Luvometinib Combined With Anlotinib in Patients With KRAS-mutated Metastatic Non-small Cell Lung Cancer","Inclusion Criteria\n\n1. aged between ≥ 18 years and ≤75 years; regardless of male or female.\n2. Histologically and\u002For cytologically confirmed diagnosis of non-small cell lung caner,and the clinical stage is IV(AJCC 4th）; Received at least one line of systemic treatment(including platinum-based chemotherapy ± PD-(L)1) during the stage IV, and disease progression occured during or after the treatment.\n3. KRAS mutation positive.\n4. ECOG score 0-1. 5. Expected survival time ≥ 3 months.\n\n6．At least one intracranial measurable lesion according to RECIST v1.1 criteria.\n\n7．Adequate organ function within 7 days before enrollment. 8. Recovery to ≤grade 1 or return to baseline from previous treatment-related adverse events (according to CTCAE 5.0), except for adverse events such as hair loss that are judged by the investigators to be safe and do not violate other inclusion criteria.\n\n9\\. Avoid excessive exposure to sunlight, and be willing to use sufficient sunscreen when there is expected to be sunlight exposure.\n\n10\\. Take contraceptive measures as required.\n\nExclusion Criteria\n\n1．Patients who have previously received any of the following treatments:\n\n1. Prior treatment with MEK inhibitors、anlotinib or other VEGFR-TKI(such as cabozantinib, sorafenib, apatinib,etc);\n2. Major surgery within 28 days or minor surgery within 14 days prior to the first dose, or need to undergo major surgery during the study treatment;\n3. Systemic anti-cancer treatment (including chemotherapy, targeted therapy, immunotherapy, and other clinical trial drug treatments) within 28 days prior to the first dose or within 5 drug half-lives (whichever is shorter).\n4. Treatment with traditional Chinese medicine, Chinese patent medicine or modern Chinese medicine preparations with anti-tumor indications within 7 days prior to the first dose;\n5. Radical radiotherapy within 28 days prior to the first dose; palliative radiotherapy allowed if ≥14 days before first dose;\n6. Live or live-attenuated vaccine within 28 days prior to the first dose; other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose;\n7. History of allogeneic organ transplantation or allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months prior to the first dose.\n\n   2．Active CNS metastases; brainstem, leptomeningeal, spinal cord metastases or spinal cord compression.\n\n   3.Small cell lung cancer (including mixed SCLC\u002FNSCLC) or cavitary central squamous cell carcinoma.\n\n   4.Receipt of ≥4 prior lines of systemic anticancer therapy. 5.Active autoimmune disease requiring systemic therapy in the past 2 years,except: stable disease on replacement therapy without systemic treatment; non-systemic dermatologic conditions (vitiligo, psoriasis) or alopecia.\n\n   6.Active infection requiring systemic therapy within 2 weeks before first dose. 7.Uncontrolled hypertension. 8.Dysphagia, active gastrointestinal disease, malabsorption, or any condition impairing study drug absorption.\n\n   9.Retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), uncontrolled glaucoma, or other ocular disease interfering with ocular toxicity assessment.\n\n   10.Current or previous idiopathic pulmonary fibrosis\u002Fpneumonitis; active ILD, pneumonitis (including clinically significant radiation pneumonitis), pulmonary fibrosis; history of tracheal fistula; continuous oxygen requirement due to severe dyspnea or respiratory insufficiency.\n\n   11.Active HBV or HCV; known AIDS or positive HIV; active tuberculosis or syphilis.\n\n   12.Tumor invasion into major vessels, heart, pericardium, trachea, esophagus, or high risk of esophagotracheal\u002Fesophagopleural fistula.\n\n   13.Significant hemoptysis within 1 month before first dose; clinically significant bleeding, bleeding tendency, coagulopathy, or history of ≥Grade 3 thrombosis.\n\n   14.Symptomatic or recurrent pleural effusion, ascites, or pericardial effusion requiring frequent drainage.\n\n   15.Other malignancy diagnosed within 5 years before first dose.","75 Years",{"count":119,"type":20},48,[50],"Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner",[123,124,125,126],"Non-small Cell Lung Caner","KRAS-mutated","Metastasis","Previous Treamted","2026-04-25",{"date":129,"type":31},"2026-05-01",{"date":131,"type":20},"2026-06",{"date":133,"type":20},"2030-06",{"name":37,"class":38},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":39},"100635862","phase-1-phase-iaib-study-of-fxb0871-monotherapy-in-locally-advancedmetastatic-solid-tumors-100635862","NCT07558200","Phase Ia\u002FIb Study of FXB0871 Monotherapy in Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1a\u002F1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic\u002FPharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥18 years.\n* Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.\n* ECOG performance status 0 or 1.\n* At least one measurable lesion per RECIST v1.1.\n* Pretreatment tumor tissue available (archival or fresh biopsy).\n* Life expectancy ≥12 weeks.\n* Oxygen saturation ≥92% on room air.\n* Left ventricular ejection fraction \\>50%.\n* Adequate hematologic, coagulation, renal, hepatic, and cardiac function.\n* Women of childbearing potential and sexually active men must use highly effective contraception.\n* Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts.\n\nKey Exclusion Criteria:\n\n* Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.\n* Prior treatment with IL-2, IL-15, or IL-7.\n* Active autoimmune disease requiring systemic treatment or immunodeficiency.\n* Systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.\n* Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.\n* Uncontrolled infection or clinically significant unresolved toxicities from prior therapy.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease, uncontrolled effusions\u002Fascites, uncontrolled hypertension, or QTcF \\>470 ms.\n* Active hepatitis B\u002FC, syphilis, or HIV infection.\n* Clinically significant interstitial lung disease or active noninfectious pneumonitis.\n* Pregnancy or breastfeeding.\n* Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.",{"count":143,"type":20},138,[74],"This is a phase 1a\u002F1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and\u002For recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.",[147,148,149],"Solid Tumors","Non-Small Cell Lung Cancer","Hepatocellular Carcinoma",[151,152,153,154,155,156],"FXB0871","TEV-56278","PD-1","IL-2","Dose Escalation","Dose Expansion","2026-04-23",{"date":159,"type":31},"2026-04-30",{"date":161,"type":20},"2026-05-15",{"date":163,"type":20},"2030-11-18",{"name":37,"class":38},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":39},"100635386","phase-2-a-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-fxs5626-in-patients-with-niu-100635386","NCT07552012","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of FXS5626 Tablets in Patients With Active Non-infectious Uveitis","Inclusion Criteria:\n\n1. Participants must be capable of understanding the trial procedures, voluntarily agree to participate, communicate effectively with the investigators, comply with all study requirements throughout the trial, and provide written Informed consent Form (ICF);\n2. At screening visit, male or female paticipants aged 18-70 years (inclusive) ;\n3. At screening visit, Body mass index (BMI) between 18 and 30 kg\u002Fm² (inclusive), with a body weight of ≥50 kg for males and ≥45 kg for females;\n4. At screening, at least one eye was diagnosed with active non-infectious uveitis by the investigator, including non-infectious intermediate uveitis, posterior uveitis, or panuveitis;\n5. Subject must have active disease at the screening and baseline visit, as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg\u002Fday to ≤ 60 mg\u002Fday (or oral corticosteroid equivalent):\n\n1\\) Active, inflammatory, chorioretinal and\u002For inflammatory retinal vascular lesion 2) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \\[SUN\\] criteria) 3) ≥ 2+ vitreous haze (National Eye Institute \\[NEI\\]\u002FSUN criteria) ; \\[6\\] Participants and their partners must have no plans for reproduction, sperm donation, or egg donation from the start of treatment until at least one month after the last dose of the investigational drug, and must voluntarily employ an effective method of contraception as determined by the investigator.\n\nExclusion Criteria:\n\n1. Participants with isolated anterior uveitis;\n2. Participants with macular edema as the sole clinical manifestation of intermediate uveitis, posterior uveitis, or panuveitis;\n3. Participants with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to Tuberculosis (TB), cytomegalovirus (CMV), Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease and herpes simplex virus (HSV);\n4. Participants with Histoplasmosis Syndrome (HS);\n5. Participants with ocular masquerade syndrome, including but not limited to the following causes: trauma, lymphoma, ocular malignant tumor, or surgery;\n6. Participants with serpiginous choroidopathy;\n7. Participants with corneal or lens opacity that precludes visualization of the fundus in either eye or that likely requires cataract surgery during the duration of the trial;\n8. Participants with severe vitreous opacity or other factors that precludes visualization of the fundus in either eye;\n9. Participant with uncontrolled glaucoma, intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury; The sponsor provides the definitive and complete eligibility criteria in the study protocol.","70 Years",{"count":174,"type":20},40,[50],"The purpose of this study is to find out the efficacy and safety of oral FXS5626 in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).",[178],"Active Non-anterior, Non-infectious Uveitis",[180,181,182,183],"Uveitis","Active","Non-anterior","Non-infectious","RECRUITING","2026-04-20",{"date":187,"type":31},"2026-04-27",{"date":189,"type":31},"2026-01-29",{"date":191,"type":20},"2027-12-31",{"name":37,"class":38},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":211,"locationsCount":39},"100631588","phase-2-fxs6837-for-the-treatment-of-igan-patients-100631588","NCT07502638","FXS6837 for the Treatment of IgAN Patients","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of FXS6837 in IgAN Patients","Inclusion criteria:\n\n1. Adult male or female patients aged ≥18 years with biopsy-confirmed primary IgA nephropathy (IgAN), meeting all of the following:\n\n   1. A qualifying renal biopsy performed within the past 8 years;\n   2. ≤50% tubulointerstitial fibrosis;\n   3. Crescent formation present in ≤50% of glomeruli;\n   4. If a historical biopsy is not available, a biopsy may be performed during screening.\n2. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m² at screening and at the end of the run-in period.\n3. Urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg at screening and at the end of the run-in period.\n4. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required prior to initiation of study treatment. If not previously vaccinated or if a booster is required, 5. vaccination should be administered according to local regulations at least 2 weeks prior to first dose. If treatment must begin earlier, prophylactic antibiotic therapy should be initiated.\n5. Patients must have received a stable dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the locally approved maximum daily dose or maximally tolerated dose (per investigator judgment), for at least 90 days prior to first dose. If receiving sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), or hydroxychloroquine, doses must also be stable for at least 90 days prior to first dose (per investigator judgment).\n\nExclusion criteria:\n\n1. Secondary IgA nephropathy (IgAN), as defined by the investigator.\n2. Rapidly progressive IgAN, defined as ≥50% decline in eGFR (CKD-EPI) within 3 months, or \\\u003C50% decline but considered by the investigator to be at risk of rapid renal function deterioration.\n3. Other systemic diseases associated with proteinuria or chronic kidney disease (e.g., diabetic nephropathy, lupus nephritis, ANCA-associated vasculitis), or severe urinary tract obstruction or dysuria.\n4. Prior treatment with immunosuppressive agents, including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF), mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids within 90 days (or 5 half-lives, whichever is longer) prior to first dose.\n5. Prior treatment with oral budesonide (Nefecon®) within 6 months prior to first dose.\n6. Prior treatment with other complement inhibitors within 30 days (or 5 half-lives, whichever is longer) prior to first dose.\n7. Positive test results for HIV; active syphilis infection; chronic hepatitis B infection (HBsAg positive with HBV DNA \\> lower limit of quantification \\[LOQ\\]); or hepatitis C infection (positive HCV antibody with detectable HCV RNA).\n8. Active tuberculosis at screening.\n9. Clinically significant abnormal liver function at screening, defined as any of the following: ALT, AST, GGT, or ALP \\>3 × upper limit of normal (ULN), or total bilirubin \\>2 × ULN.\n10. History of meningococcal infection.\n11. Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days prior to first dose, or body temperature \\>38°C within 7 days prior to first dose.",{"count":48,"type":20},[50],"This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.",[204],"IgAN","2026-03-27",{"date":207,"type":31},"2026-03-31",{"date":207,"type":20},{"date":210,"type":20},"2027-11-14",{"name":37,"class":38},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":232,"locationsCount":39},"100619516","phase-1-phase-i-study-of-fxs887-in-the-treatment-of-solid-tumors-100619516","NCT07345637","Phase I Study of FXS887 in the Treatment of Solid Tumors","A Single-Arm, Open-Label, Dose-Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FXS887 in Patients With Advanced Solid Tumors","FXS887-I101","Inclusion Criteria:\n\n1. Aged ≥ 18 years, male or female;\n2. Participants must fully understand the requirements of the study and voluntarily sign the written informed consent;\n3. Participants with histologically\u002Fcytologically confirmed advanced solid tumors who have received ≥ 1 line of systemic therapy prior to enrollment in the study and experienced failure of standard therapy (disease progression or intolerance);\n4. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, participants must have at least one measurable target lesion;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n6. Estimated life expectancy of ≥ 12 weeks;\n7. Participants must have adequate organ and bone marrow function.\n8. For female participants of childbearing age, the serum pregnancy test within 7 days prior to the first dose of the study drug must be negative; eligible participants of reproductive potential (both males and females) must agree to use reliable contraceptive methods (hormonal, barrier, abstinence, etc.) with their partners during the study period and for at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Within the washout period of prior anti-tumor medication treatment (4 weeks or 5 half-lives after the last dose, whichever is longer) prior to the first dose of FXS887;\n2. Have participated in another clinical study within 4 weeks prior to the first dose of FXS887;\n3. Have a history of hypersensitivity to any known components of FXS887 or its analogues;\n4. Have intolerance to ATR inhibitors or have received ATR inhibitors within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of FXS887;\n5. Need to take strong CYP3A inhibitors and\u002For inducers, as well as P-gp (P-glycoprotein) inhibitors and\u002For inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of FXS887 and during the study period;\n6. Need to take drugs known to prolong the QTc interval during the study period;\n7. Have had other malignant tumors within 2 years prior to the first dose of FXS887, except for local tumors that have been cured and judged by the investigator to have a low risk of recurrence;\n8. Have received radiation therapy within 14 days prior to the first dose of FXS887;\n9. Have not recovered from adverse events caused by prior anti-cancer treatment (recovered to Grade 1 or baseline), except for alopecia, pigmentation of any grade, Grade ≤2 peripheral sensory neuropathy, and items explicitly specified in the inclusion criteria;\n10. Have refractory nausea and vomiting, chronic gastrointestinal diseases including but not limited to active diverticulitis and symptomatic peptic ulcers, inability to swallow oral medications, or a history of extensive small bowel resection or other conditions that significantly impair gastrointestinal absorption as judged by the investigator;\n11. Have undergone major surgery within 2 weeks prior to the first dose or have not recovered from surgical complications;\n12. Have primary central nervous system (CNS) tumors, meningeal metastasis, spinal cord compression, or brainstem metastasis; participants with known untreated brain metastases or symptomatic or unstable disease are excluded; participants who have completed treatment for brain metastases (radiation therapy or surgery) with stable metastases and no relevant symptoms (without medication control) within 4 weeks prior to the first dose may be enrolled;\n13. Have severe cardiovascular diseases;\n14. Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and medical intervention;\n15. Have active infections requiring treatment (e.g., participants are receiving anti-infective treatment) within 14 days prior to the first dose of FXS887, including Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), uncontrolled active Hepatitis B virus (HBV) infection, syphilis infection, known active tuberculosis, etc.\n16. Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):\n\n    * participants with controlled HBV infection (serum HBV-DNA \\\u003C 500 IU\u002FmL or \\\u003C 2,000 copies\u002FmL) are allowed to enroll in this study.\n    * participants who are HCV antibody-positive with controlled infection \\[polymerase chain reaction (PCR) for serum HCV-RNA below the lower limit of detection\\] are allowed to enroll in this study.\n17. History of human immunodeficiency virus (HIV) infection;\n18. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or clinically active ILD;\n19. Known substance abuse or psychiatric disorder that may interfere with compliance with study requirements;\n20. Participants are pregnant, breastfeeding, or planning to become pregnant during the study period;\n21. Investigator considers the participant has other factors that may affect study results or interfere with participation in the entire study, including past or existing medical conditions, treatment or laboratory abnormalities, or unwillingness to comply with study procedures, restrictions, and requirements-any condition deemed unsuitable for enrollment by the investigator.",{"count":221,"type":20},14,[74],"This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. FXS887 is a innovative ATR inhibitors of a class of small-molecule inhibitors targeting ATR kinase.",[225],"Solid Tumor Refractory to Conventional Treatment","2026-01-07",{"date":228,"type":31},"2026-01-16",{"date":230,"type":20},"2026-01-05",{"date":191,"type":20},{"name":37,"class":38},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":39},"100594818","phase-1-follow-up-study-to-evaluate-the-safety-and-efficacy-of-fcn-159-in-pediatric-participants-with-neurofibromatosis-type-1-100594818","NCT07024394","Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1","A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1","Inclusion Criteria:\n\nPatients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form.\n\nExclusion Criteria:\n\nAny clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.\n\nPatients unable to comply with visit-related requirements.","2 Years","20 Years",{"count":243,"type":20},65,[74,50],"FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1\u002F2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.",[247,248,249],"Neurofibromatosis 1","Plexiform Neurofibroma","NF1","2025-06-09",{"date":252,"type":31},"2025-06-17",{"date":254,"type":20},"2025-06-12",{"date":256,"type":20},"2029-09-23",{"name":37,"class":38},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":240,"maxAge":17,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":39},"100593256","phase-3-fcn-159-monotherapy-versus-chemotherapy-by-investigators-choice-in-pediatric-low-grade-glioma-patients-with-braf-alteration-100593256","NCT07004075","FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration","An Open-label, Randomized, Multi-center Phase III Clinical Study: Aim to Evaluate the Efficacy and Safety of FCN-159 Monotherapy Versus the Treatment by Investigator's Choice in Patients With Pediatric Low-grade Glioma Harboring KIAA1549-BRAF Fusion or BRAF V600E Mutation","Inclusion Criteria:\n\n1. Pediatric patients aged between ≥ 2 years and \\\u003C 18 years; regardless of male or female.\n2. Histologically and\u002For cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).\n3. KIAA1549-BRAF fusion or BRAF V600E mutation-positive.\n4. Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.\n5. At least one intracranial measurable lesion that can be reproducibly measured in two dimensions on T2-FLAIR, with the minimum size of the bi-perpendicular diameter of ≥ 10 mm, and can be visible on two or more imaging slice.\n\n6\\. Karnofsky performance score or Lansky performance score ≥ 70. 7．Adequate organ function within 14 days before enrollment.\n\nExclusion Criteria:\n\n1. Patients who have previously received any of the following treatments:\n\n   1. Patients who have received chemotherapy drugs or traditional Chinese medicines or herbals with definitive anti-tumor treatment within 4 weeks preceding the first dose of investigational drug;\n   2. Patients who have received growth factors that promote platelet or leukocyte count or function within 14 days preceding the first dose of investigational drug;\n   3. Patients who received radiotherapy, surgery or immunotherapy within 4 weeks preceding the first dose of investigational drug;\n   4. Patients who have participated in other interventional clinical trials within 4 weeks before receiving the first dose of investigational drug;\n   5. Patients who have received live vaccines within 4 weeks preceding the first dose of investigational drug, or patients who have received inactivated vaccines and mRNA vaccines within 14 days preceding the study treatment;\n   6. Patients who have previously received any other MEK 1\u002F2 inhibitors such as Selumetinib or BRAF inhibitors such as Dabrafenib.\n2. Patients with high-grade gliomas, as well as schwannoma, subependymal giant cell astrocytoma (tuberous sclerosis), and diffuse intrinsic pontine gliomas (even if the histological diagnosis is WHO Grade 1 or 2).\n3. Patients who require endotracheal intubation for assisted ventilation or tracheotomy should be excluded.\n4. Patients who have uncontrollable epilepsy as assessed by the investigator.\n5. Patients with dysphagia, active GI diseases, malabsorption syndrome, or other conditions that will interfere with the absorption of the investigational drug.\n6. Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeding 1000 IU\u002Fml. Hepatitis B carriers are allowed to be enrolled. Patients with positive hepatitis C virus (HCV) antibody test; those who have confirmed human immunodeficiency virus (HIV) infection, and are unwilling to undergo HIV testing.\n7. Patients with history or current evidence of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), central retinal vein occlusion, glaucoma, and other significant abnormalities in ophthalmological examinations.\n8. Interstitial pneumonia, including clinically significant radiation pneumonitis.\n9. Grade 3 creatine phosphokinase increased (\\>5 × ULN - 10 × ULN).",{"count":266,"type":20},102,[23],"An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation",[270,271,272],"Low-grade Glioma","Pediatric Low-grade Gliomas","pLGG With BRAF Alteration","2025-06-03",{"date":275,"type":31},"2025-06-04",{"date":277,"type":20},"2025-06-30",{"date":279,"type":20},"2029-04-30",{"name":37,"class":38},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":240,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100515906","phase-2-to-evaluate-the-efficacy-safety-and-pk-characteristics-of-fcn-159-in-pediatric-patients-with-refractoryrecurrent-lch-100515906","NCT05997602","To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory\u002FRecurrent LCH","A Multi-center, Open-label, Single Arm Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of FCN-159 in Pediatric Patients With Refractory\u002FRecurrent Langerhans Cell Histiocytosis","Inclusion Criteria:\n\n1. Age 2-16 (inclusive)\n2. Patients with histologically confirmed Langerhans cell histiocytosis (LCH) diagnosed by the central laboratory.\n3. If sufficient tumor tissue samples and peripheral blood samples are available, central laboratory biomarker testing is required as follows: including but not limited to ERBB3, BRAF, ARAF, HRAS, KRAS, NRAS, MEK (MAP2K1 and MAP2K2), and other MEK upstream genes.If inability to get tissue, the gene testing results from a local laboratory also can be accepted.\n4. Patients who have received at least prior first-line systemic treatment, defined as treatment including vinblastine (VBL) and glucocorticoids for at least 2 weeks. VBL can be substituted with vincristine (VCR) or vindesine (VDS). Alternatively, patients may be unable to tolerate chemotherapy due to severe chemotherapy toxicity. Inability to tolerate chemotherapy is defined as one of the following: Severe liver impairment (liver enzyme elevation ≥ 5 × upper limit of normal (ULN) and bilirubin elevation ≥ 1.5 × ULN), severe neurotoxicity related to vinca alkaloids, chemotherapy-related intracranial hypertension, or grade 4 bone marrow depression with severe infection (sepsis, severe pneumonia, etc.) after chemotherapy.\n5. Refractory\u002Frelapsed LCH is defined as the presence of one of the following:\n\n   1. Failure of prior treatment, i.e., no regression in risk organs after at least 2 weeks of systemic treatment, or overall evaluation of AD-progression or AD-mix;\n   2. Initial response of the disease to first or second-line systemic treatment is NAD or AD-better or AD-stable, followed by disease reactivation after maintenance therapy for more than 3 months. Second-line treatment includes cytarabine and\u002For cladribine.\n   3. Persistent mutated gene positive in plasma free DNA testing during prior treatment (confirmed by 2 consecutive tests) or retest positive after treatment discontinuation;\n   4. Lack of regression in the affected central nervous system (including the pituitary gland) after treatment;\n   5. Presence of bone marrow involvement and\u002For hemophagocytic lymphohistiocytosis (HLH);\n6. Presence of evaluable lesions based on PET response criteria (PRC).\n7. Patients who have to have recovered from all acute toxic effects of prior anti-tumor therapy, and all relevant toxicities must be ≤ grade 1 (except for alopecia and ototoxicity).\n8. Expected survival at least ≥ 3 months;\n9. Lansky (≤ 15 years old) and Karnofsky (≥ 16 years old) performance status scores should be ≥ 50%, as shown in Appendix 4.\n10. Patients or their legal guardians must be able to understand and willingly sign a written informed consent form.\n11. For women of childbearing potential, a serum human chorionic gonadotropin (HCG) pregnancy test must be negative within 7 days before starting treatment.\n12. For female patients of childbearing potential: Patients should agree to use effective contraception methods during the treatment period and for at least 90 days after the last dose of study treatment, using dual barrier contraception methods such as condoms, oral or injectable contraceptives, intra-uterine contraceptive devices, etc. Male patients should agree to refrain from donating sperm for at least 90 days after the last dose of study treatment.\n13. Adequate bone marrow function: Absolute neutrophil count ≥ 1.0×10\\^9\u002FL, hemoglobin ≥ 90g\u002FL, and platelets ≥ 75×10\\^9\u002FL without the use of blood transfusions, blood products, or granulocyte colony-stimulating factors. Patients with hematocytopenia below these thresholds due to the underlying disease may be considered for inclusion based on the investigator's comprehensive judgment.\n14. Adequate hepatic and renal function: Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN), or ≤ 5× ULN for patients with Gilbert's syndrome or liver involvement; aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AKP) ≤ 2.5 × ULN, or ≤ 10 × ULN for patients with liver involvement; albumin ≥ 3g\u002FdL; and creatinine clearance or isotopic glomerular filtration rate (GFR) ≥ 50ml\u002Fmin\u002F1.73㎡or serum creatinine based on age; hepatic and renal impairment caused by the primary disease may be considered for inclusion based on the investigator's comprehensive judgment.\n15. Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.\n\nExclusion Criteria:\n\n1. Patients who have received any of the following prior treatments:\n\n   1. Chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal anti-tumor therapy for LCH within 4 weeks or \\\u003C 5 half-lives (whichever is shorter)before the start of the study drug .\n   2. Strong CYP3A4, CYP2C8, and CYP2C9 inhibitors or inducers within 14 days before the start of the study drug, except for topical skin application.\n   3. Gowth factors that promote platelet or white blood cell count or function within 7 days before the start of the study drug.\n   4. Radiotherapy or major surgical treatment (including craniotomy, thoracotomy, laparotomy, open bone or joint surgery, etc.) within 4 weeks before the start of the study drug.\n   5. Participated in other interventional clinical trials within 4 weeks before the start of the study drug.\n   6. MEK 1\u002F2 inhibitors (those who have received this treatment for a short period of ≤ 2 weeks may be included).\n   7. Anticoagulants within 7 days before the start of the study drug for patients with brain tumors (intracranial masses).\n   8. Prednisone treatment \\\u003C 0.5mg\u002Fkg\u002Fday (or equivalent dose of other corticosteroids) is allowed within one month before enrollment, but must be discontinued 14 days before the start of the study drug. Patients with brain lesions receiving corticosteroid therapy for brain edema must maintain a stable dose for 14 days before enrollment. Hormone replacement therapy is allowed for patients with hypopituitarism due to primary disease involvement of the pituitary.\n2. Patients with a history of other malignant tumors or concurrent other malignant tumors (excluding cured non-melanoma skin basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ).\n3. Uncontrolled hypertension (with medication treatment): Blood pressure (BP) greater than or equal to the 95th percentile for age, height, and sex, as described in Appendix 6.\n4. Patients with dysphagia, active gastrointestinal disease, malabsorption syndrome, or other conditions that may affect the absorption of the study drug.\n5. Prior or current history of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), glaucoma, and other clinically significant abnormal ophthalmologic examination results.\n6. Interstitial pneumonia, including clinically significant radiation pneumonitis. Except for interstitial pneumonia caused by pulmonary involvement of the primary disease.\n7. Patients will be excluded if their cardiac function or comorbidities meet any of the following criteria:\n\n   1. During the screening period, 12-lead electrocardiogram (ECG) measurements will be taken three times at the study center with a mean value calculated using the QTcF formula provided by the instrument; patients with a mean value of QTcF \\> 470 milliseconds or with risk factors for QTcF prolongation, such as uncorrected hypokalemia, congenital long QT syndrome, or receiving drugs known to prolong QTcF interval (mainly class Ia, Ic, and III antiarrhythmic drugs) will be excluded from the study. Drugs with the potential to prolong the QTcF interval are listed in Appendix 7.\n   2. New York Heart Association (NYHA) Class 2 and above congestive heart failure as shown in Appendix 5.\n   3. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, and second-degree atrioventricular block.\n   4. Known presence of clinically significant coronary heart disease, cardiomyopathy, or severe valvular disease.\n   5. Echocardiography examination indicating left ventricular ejection fraction (LVEF) \\\u003C 50%.\n8. Patients with active bacterial, fungal, or viral infections, including active hepatitis B (defined as positive hepatitis B surface antigen and hepatitis B virus DNA \\> 1000IU\u002Fml or meeting the diagnostic criteria for active hepatitis B infection at the study center) or hepatitis C (positive hepatitis C virus RNA), or human immunodeficiency virus (HIV positive) infection.\n9. Patients with known allergies to the study drug, other MEK1\u002F2 inhibitors, or their excipients.\n10. Patients with known tumor tissue genetic testing that indicates the presence of MAP2K1 exon 3 deletions (del) or deletion-insertion type (delins\u002Findels) mutations.\n11. The investigator considers clinically significant cases that will impede participation in the study or prevent compliance with safety requirements.","16 Years",{"count":290,"type":20},56,[50],"This is a rare disease, single-arm, open-label,multi-center, non-randomized Phase 2 clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of FCN-159 monotherapy in pediatric patients with refractory\u002Frecurrent Langerhans cell histiocytosis (LCH).",[294,295],"Langerhans Cell Histiocytosis","LCH","2025-01-22",{"date":298,"type":31},"2025-01-24",{"date":300,"type":31},"2023-09-28",{"date":302,"type":20},"2027-05-14",{"name":37,"class":38},11,""]