[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chengdu Zenitar Biomedical Technology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":230},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,67,87,106,129,149,170,191,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637280","phase-1-material-balance-study-of-14c-flonoltinib-maleate-100637280",false,"NCT07612306","Material Balance Study of [14C] Flonoltinib Maleate","A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects","Inclusion Criteria:\n\n1. Chinese healthy adult male, aged 18-45 years old\n2. Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg\u002Fm\\^2\n3. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.\n\nExclusion Criteria:\n\n1. Screening period electrocardiogram examination: Fridericia formula (QTcF=QT\u002F(RR \\^ 0.33)) corrected QT interval (QTcF)\\>450 milliseconds\n2. HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag\u002FAb combined test\n3. Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results\n4. Individuals who have consumed any food or beverage containing alcohol, grapefruit juice\u002Fgrapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice\u002Fgrapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc\n5. Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (\\>=2 chest\u002Fabdominal CT scans, or \\>= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year\n6. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection",true,"MALE","18 Years","45 Years",{"count":21,"type":22},6,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of \\[14C\\]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways;2.Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of fluorotinib maleate in healthy adult male participants;3.Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma.\n\nSecondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS\u002FMS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma;2.Evaluate the safety and tolerability of \\[14C\\]Flonoltinib Maleate after a single oral administration in healthy adult male participants.",[28],"MF","NOT_YET_RECRUITING","2026-05-27",{"date":32,"type":33},"2026-05-28","ACTUAL",{"date":35,"type":22},"2026-06-30",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"Chengdu Zenitar Biomedical Technology Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100627028","phase-2-a-clinical-trial-of-flonoltinib-maleate-tablets-in-the-treatment-of-jak-inhibitor-refractoryrelapsedintolerant-patients-with-medium-to-high-risk-myelofibrosis-100627028","NCT07443306","A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory\u002FRelapsed\u002FIntolerant Patients With Medium to High Risk Myelofibrosis","Flonoltinib Maleate for the Treatment of Patients With Intermediate- or High-risk Myelofibrosis Who Are Refractory, Relapsed, or Intolerant to JAK Inhibitors a Single-arm, Open-label, Multicenter Phase IIb Clinical Trial Evaluating Efficacy and Safety","Inclusion Criteria:\n\n1. Age range of 18-80 years old (including threshold), gender not limited;\n2. Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;\n3. Patients with myelofibrosis assessed as intermediate-2 or high-risk according to the dynamic international prognostic scoring system (DIPSS) prognostic classification criteria;or patients with intermediate-1 myelofibrosis who exhibit hepatosplenomegaly and require treatment;\n4. MF patients who have received JAK inhibitor treatment in the past and meet the criteria of refractory\u002Frecurrent\u002Fintolerant;\n5. Expected survival period greater than 24 weeks;\n6. ECOG score 0-2 points;\n7. Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to physical reasons (such as obesity), it may not be palpable, but MRI\u002FCT spleen evaluation during screening confirms a volume of \\>= 450 cm\\^3;\n8. Peripheral blood and bone marrow blasts \\\u003C=10%;\n9. Within 7 days prior to randomization, ANC \\>=1.0 × 10\\^9\u002FL, platelet count \\>=100 × 10\\^9\u002FL, HGB\\>60 g\u002FL ;\n10. Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST \\\u003C= 2.5 × ULN; TBIL\\\u003C=2.0×ULN; Serum creatinine \\\u003C=1.5 × ULN or serum creatinine clearance rate (Ccr)\\>50 mL\u002Fmin; INR, PT, and APTT \\\u003C= 1.5 × ULN;\n11. Can understand and voluntarily sign an informed consent form..\n\nExclusion Criteria:\n\n1. The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries(such as undergoing major surgery within 4 weeks);\n2. Allergy to experimental drugs and their excipients;\n3. For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose\\>250 mg\u002FdL (13.9 mmol\u002FL), b. hypertension and cannot be reduced to the following range after treatment with two or more antihypertensive drugs (systolic blood pressure\\\u003C160 mmHg, diastolic blood pressure\\\u003C100 mmHg), c. peripheral neuropathy;\n4. Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;\n5. Individuals with impaired cardiac function (those with ejection fraction\\\u003C45% detected by echocardiography, congenital ventricular arrhythmia, QTcF\\>450 ms on electrocardiogram (males), QTcF\\>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);\n6. Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;\n7. Any active infections requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within 14 days prior to enrollment;\n8. Individuals who have experienced active tuberculosis infection within the 48 weeks prior to screening or those who have been diagnosed with latent tuberculosis infection during the screening period (those diagnosed with latent tuberculosis infection must complete preventive anti tuberculosis treatment for at least 3 months before they can be enrolled);\n9. Patients who have undergone splenectomy in the past or those who have received splenic radiation therapy within the 12 months prior to their first dose;\n10. Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and undergo peripheral blood HBV-DNA testing, with the lower limit of HBV-DNA detection value (i.e. the upper limit of normal value in the laboratory of each research center) can be enrolled; If the baseline HBsAg is positive, continuous antiviral treatment is required after enrollment, and HBV-DNA testing should be conducted every 12 weeks and at EOT visits; b) Patients who are positive for HCV serology but negative for HCV-RNA can be included in the study;\n11. Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);\n12. Patients with epilepsy or those taking psychotropic or sedative drugs during screening;\n13. Pregnant or lactating female patients, female\u002Fmale patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;\n14. Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);\n15. Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders;\n16. Combining other serious illnesses, researchers believe may affect patient safety or compliance;\n17. Patients who have participated in clinical trials of other new drugs or medical devices within one month before the first administration and have taken the study drug or used the study device;\n18. Select patients who have used JAK inhibitors within the previous 4 weeks or 5 half lives (whichever is longer);\n19. Patients who have used any MF drug (including traditional Chinese patent medicines and simple preparations with anti-tumor indications), androgen, any immunomodulator (such as thalidomide), any immunosuppressant, prednisone\\>10 mg\u002Fday or glucocorticoid with the same biological effect intensity within 2 weeks or 5 half-life periods (whichever is the elder) before screening;\n20. Researchers believe that there are other factors that are not suitable for participating in the experiment.","ALL","80 Years",{"count":52,"type":22},64,[54],"PHASE2","This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the moderate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Select successful trial participants and allocate flonoltinib maleate tablets based on platelet count levels during the screening period, qd,Oral administration on an empty stomach until the participants meet the withdrawal criteria.",[28],"RECRUITING","2026-05-12",{"date":60,"type":33},"2026-05-13",{"date":62,"type":33},"2026-03-18",{"date":64,"type":22},"2028-03-30",{"name":39,"class":40},2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":66},"100617367","phase-3-a-clinical-trial-of-flonoltinib-maleate-for-intermediate-or-high-risk-myelofibrosis-100617367","NCT07317700","A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis","A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis","Inclusion Criteria:\n\n1. Age range of 18-80 years old (including threshold), gender not limited;\n2. Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;\n3. Expected survival period greater than 24 weeks;\n4. ECOG score 0-2 points;\n5. Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to physical reasons (such as obesity), it may not be palpable, but MRI\u002FCT spleen evaluation during screening confirms a volume of \\>= 450 cm\\^3;\n6. Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST \\\u003C= 2.5 × ULN; TBIL\\\u003C=2.0×ULN； Serum creatinine \\\u003C=1.5 × ULN or serum creatinine clearance rate (Ccr)\\>50 mL\u002Fmin; INR, PT, and APTT \\\u003C= 1.5 × ULN;\n7. Can understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries;\n2. Allergy to experimental drugs and their excipients;\n3. For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose\\>250 mg\u002FdL (13.9 mmol\u002FL), b. hypertension and cannot be reduced to the following range after treatment with two or more antihypertensive drugs (systolic blood pressure\\\u003C160 mmHg, diastolic blood pressure\\\u003C100 mmHg), c. peripheral neuropathy;\n4. Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;\n5. Individuals with impaired cardiac function (those with ejection fraction\\\u003C45% detected by echocardiography, congenital ventricular arrhythmia, QTcF\\>450 ms on electrocardiogram (males), QTcF\\>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);\n6. Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;\n7. Any active infection requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within the first 14 days of randomization;\n8. Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and undergo peripheral blood HBV-DNA testing, with the lower limit of HBV-DNA detection value (i.e. the upper limit of normal value in the laboratory of each research center) can be enrolled; If the baseline HBsAg is positive, continuous antiviral treatment is required after enrollment, and HBV-DNA testing should be conducted every 12 weeks and at EOT visits; b) Patients who are positive for HCV serology but negative for HCV-RNA can be included in the study;\n9. Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);\n10. Patients with epilepsy or those taking psychotropic or sedative drugs during screening;\n11. Pregnant or lactating female patients, female\u002Fmale patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;\n12. Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);\n13. Patients with combined swallowing difficulties;\n14. Patients who participated in clinical trials of other new drugs or medical devices within the first month of randomization and took the study drug or used the study device;\n15. Researchers believe that there are other factors that are not suitable for participating in the experiment.",{"count":75,"type":22},105,[77],"PHASE3","This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug\u002Fcontrol drug until it meets the withdrawal criteria.",[28],"2026-03-02",{"date":82,"type":33},"2026-03-04",{"date":84,"type":33},"2026-02-13",{"date":64,"type":22},{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100610800","phase-2-phase-iia-study-on-flonoltinib-maleate-tablets-in-the-treatment-of-patients-with-polycythemia-vera-100610800","NCT07232290","Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera","An Open Label, Randomized, Parallel Controlled, Multicenter Phase IIa Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Flonoltinib Maleate Tablets in the Treatment of Hydroxyurea or Interferon Resistant\u002FIntolerant Polycythemia Vera","Inclusion Criteria:\n\n1. Age \\>= 18 years old and gender not limited when signing the informed consent form;\n2. Diagnosed as PV according to WHO standards (2016 edition), and resistant\u002Fintolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2);\n3. When screening, the peripheral blood primitive cells are 0%;\n4. Meet any of the following criteria and achieve HCT\\\u003C= 45% before randomization\u002Fenrollment:\n\n1)At least 2 venous bloodletting and\u002For apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one venous bloodletting and\u002For apheresis treatment has been performed within the 16 weeks and HCT\\>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count \\>= 1.0 × 10 \\^ 9\u002FL, platelet count \\>= 100 × 10 \\^ 9\u002FL and \\\u003C= 1000 × 10 \\^ 9\u002FL; ALT and AST\\\u003C= 2.5 × ULN; TBIL\\\u003C=2.0×ULN; Serum creatinine \\\u003C= 1.5 × ULN; 6.ECOG 0-2 points; 7.Can understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with allergies or suspected allergies to the test drug and its excipients;\n2. The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss, blood routine and blood biochemical indicators refer to inclusion criteria 4 and 5), or have not fully recovered from previous surgeries (having undergone major surgery within 4 weeks);\n3. In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present;\n4. Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening;\n5. Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders are included in the screening process;\n6. Patients with basic diseases that are difficult to control in combination with drug treatment during screening, including but not limited to: diabetes, hypertension , peripheral neuropathy ;\n7. Screening for individuals who have experienced congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or require treatment for arrhythmia within the past 6 months;\n8. Individuals with QTcF\\>450 ms (male) and QTcF\\>470 ms (female) on electrocardiogram during screening;\n9. Individuals who have experienced active tuberculosis infection within the past year prior to screening, or those whose tuberculosis related test results indicate latent infection during screening;\n10. Patients who have undergone splenectomy or splenic radiotherapy in the past;\n11. When screening, any of the following situations exist: a) Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) is positive, and HBV-DNA detection is positive or above the upper limit of normal value; b) HCV antibody positive and HCV-RNA detection positive; c) Positive for anti Treponema pallidum antibody (TP Ab) and positive for Treponema pallidum non-specific antibody (PRP or TRUST) detection; d) Positive for Human Immunodeficiency Virus Antibody (HIV Ab);\n12. Individuals with epilepsy or mental illnesses requiring medication during screening (excluding insomnia);\n13. Individuals who have suffered from other malignant tumors within the past 5 years prior to the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);\n14. Patients with congenital or acquired bleeding disorders or active thrombotic disorders during screening;\n15. Combining other serious diseases during screening may affect patient safety or compliance, according to researchers;\n16. Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea, recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks), JAK inhibitors (such as Ruxolitinib), 32P (needs to be discontinued for 8 weeks), Busulfan, etc;\n17. Patients who receive treatment with other clinical trial drugs or clinical trial medical devices before screening and have not fully eluted for at least 5 half lives or 1 month (whichever is longer);\n18. Pregnant or lactating women;\n19. Individuals who have the ability to conceive but refuse to use contraceptive measures during the trial period ;and within 6 months after the trial ends;\n20. Vaccination with active or attenuated vaccines within 4 weeks prior to screening;\n21. Researchers believe that there are other factors that are not suitable for participating in the experiment.",{"count":95,"type":22},60,[54],"This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant\u002Fintolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.",[99],"Polycythemia Vera (PV)",{"date":82,"type":33},{"date":102,"type":33},"2025-09-23",{"date":104,"type":22},"2028-02-28",{"name":39,"class":40},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100607825","phase-2-a-phase-ii-clinical-study-evaluating-of-zl-82-tablets-in-atopic-dermatitis-100607825","NCT07193589","A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study Evaluating the Efficacy and Safety of ZL-82 Tablets in Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Male or female individuals aged 18 years and above and 75 years and below (inclusive of the threshold value, based on the date of signing the ICF), with BMI \\>= 19 kg\u002Fm2.\n2. Participants are fully informed of the purpose and requirements of this trial, and voluntarily sign the informed consent form.\n3. According to the Hanifin \\& Rajka diagnostic criteria (≥ 3 out of 4 main 4, \\>= 3 out of 23 secondary symptoms, see Appendix 1), diagnosed as AD by the investigators, and with a history of AD for \\>= 1 year before screening.\n\n4 . The definition of moderate to severe atopic dermatitis during screening and baseline period is as follows:\n\n1. IGA score of 3 or 4;\n2. EASI score \\>= 16;\n3. Average peak pruritus NRS score \\>= 4 in the past week (Note: The NRS average value is the average of the maximum NRS score of pruritus intensity over 7 consecutive days before baseline, with a score range of 0-10 for each day. At least 4 days of scores are required for the calculation of the average score);\n4. BSA (body surface area) affected by AD \\>= 10% (BSA: body surface area, in this trial, BSA is based on the average human body surface area of 1.6 m2); 5. Participants who have been treated with local corticosteroid drugs, calcineurin inhibitors, or phototherapy within the past 6 months, and whose medical history indicates inadequate response, no response, or intolerance to these treatments, or who have medical contraindications for such treatments (treatment duration ≥ 4 weeks), and who require systemic treatment to control the disease, should be selected. Note: For stable treatment response that is insufficient when using local drugs (such as moderate-to-high potency topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)), insufficient response is defined as participants receiving treatment for the recommended duration or the maximum recommended duration as per the instructions, but failing to achieve and maintain disease remission (corresponding to IGA score = 0 \\[clear\\] - 2 \\[mild\\]).\n\n   6\\. Use a mild moisturizing agent (moisturizing cream) at a stable dose twice a day for at least 7 consecutive days before the first day of administration, and agree to continue using it during the study.\n\nExclusion Criteria:\n\n1. Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors.\n2. Use of any of the following drugs or treatments:\n\n   a. Within 1 month before the baseline, received other oral JAK inhibitor treatment, or had a lack of efficacy or intolerance to other oral JAK inhibitors, including but not limited to baricitinib, upadacitinib, abrocitinib, etc.; b. Within 6 weeks before the baseline, used upadilunab\u002Fspicibaydin; c. Within 3 months before the baseline (or within 5 drug half-lives, whichever is longer), used other systemic biological agents known or potentially affecting AD other than dupilumab (such as IL-13 receptor antibody \\[crizorilumab\\], IL-31Rα antibody \\[nimotuzumab\\] etc.); d. Within 1 week before the baseline, used any AD topical treatment: TCS, TCI, PDE-4 inhibitor, JAK inhibitor, traditional Chinese medicine \u002F Chinese patent medicine, herbal medicine, etc.; e. Within 4 weeks before the baseline (or within 5 half-lives, whichever is longer), used any systemic treatment for AD: immunosuppressants (such as cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, etc.), glucocorticoids, PDE-4 inhibitor, etc.; f. Within 4 weeks before the baseline received any systemic treatment for AD or other autoimmune inflammatory diseases, common AD herbal medicine preparations or Chinese patent medicines; g. Within 4 weeks before the baseline received phototherapy (narrow-band ultraviolet B \\[NBUVB\\], ultraviolet B \\[UVB\\], ultraviolet A1 \\[UVA1\\], psoralen + ultraviolet A \\[PUVA\\]), sunbed or any other light-emitting device treatment; h. Within 6 months before the baseline received allergen-specific immunotherapy; i. Within 2 weeks before the baseline or within 5 half-lives of the drug (whichever is longer), systemically used (or expected to be needed throughout the study period) strong or moderate inhibitors or inducers of cytochrome P450 (CYP) (see Appendix II); j. Within 2 weeks before the baseline or within 5 half-lives of the drug (whichever is longer), systemically used (or expected to be needed throughout the study period) P-glycoprotein (P-gp) inhibitors (see Appendix II); k. Had received lymphocyte depletion therapy before (such as: alegrucilunab, anti-CD4 drugs, cladribine, rituximab, omalizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, darzalex); l. Within 3 months before the baseline or within 5 half-lives of the drug (if known, whichever is longer), received any treatment in clinical studies of drugs or medical devices, or was currently enrolled in another interventional study.\n3. Individuals with a history of major diseases: This includes but is not limited to those with a history of diseases in the digestive system, cardiovascular system, respiratory system, musculoskeletal system, endocrine system, nervous and mental system, hematological system, immune system disorders, thromboembolic diseases (or individuals at high risk of thromboembolism), and metabolic abnormalities, or those who have undergone major surgeries, or any other diseases or physiological conditions that the investigator deems may affect the trial results.\n4. Family Planning: a. Pregnant or lactating women; b. Throughout the entire study period, all participants or their spouses (or partners) who have reproductive capacity must ensure to take effective contraceptive measures from the moment of signing the informed consent form until 90 days after the last administration of the drug (contraceptive measures and requirements are detailed in Appendix III); c. Those who plan to donate eggs or sperm during the trial period and within 3 months after the last administration.\n5. Those who have a history of malignant tumors in the past, including solid tumors and hematological malignancies (excluding basal cell carcinoma and cutaneous squamous cell carcinoma that have been removed or cured).\n6. Those who have undergone major surgical procedures within 4 weeks before screening or are scheduled to undergo such procedures during the screening period.\n7. Those whose hepatitis B surface antigen or hepatitis B core antibody (except for HBV DNA results within the normal range) is positive, hepatitis C antibody (except for HCV RNA results within the normal range) is positive, human immunodeficiency virus antibody is positive, or Treponema pallidum antibody is positive (excluding those with negative RPR\u002FTRUST test results).\n8. Participants should have resting systolic blood pressure (SBP) \\\u003C 90 mmHg and\u002For diastolic blood pressure (DBP) \\\u003C 55 mmHg before the first administration. Participants with hypertension (SBP \\>= 160 mmHg, DBP \\>= 100 mmHg) treated with two or more antihypertensive drugs but with poor control, and those with severe sleep apnea and other diseases, and those judged by the investigators to have conditions that may interfere with the clinical trial results or affect the safety of the participants.\n9. 12-lead ECG before screening and before the first administration suggests that the PR interval \\> 200 msec, heart rate \\\u003C 55 bpm, and corrected Fridericia QT interval (QTcF) \\>= 450 ms (for males), and \\>= 470 ms for females. 10. Participants with a history of severe cardiovascular and cerebrovascular diseases and poor control, including myocardial infarction, unstable angina pectoris, congestive heart failure, congenital heart disease, stroke or transient ischemic attack; and those with bleeding tendencies, or who have had intracerebral hemorrhage within the past 1 year.\n\n11\\. Those with any of the following medical histories:\n\na. Symptoms of bradycardia or related medical history; b. Second or third degree atrioventricular block; c. Cardiac arrest duration \\> 3 seconds; d. History of sick sinus syndrome or neurocardiac syncope. 12. Those with a history of uncontrolled diabetes (defined as HbA1c \\> 9%). 13. Those with any systemic disease that may affect the evaluation of the trial results or active other skin diseases (such as psoriasis, lupus erythematosus, Netherton syndrome, chronic actinic dermatitis, dermatitis herpetiformis), or those with scars, freckles, tattoos, obvious pigmentation and other factors that may affect the evaluation of skin lesions at the affected sites.\n\n14\\. Those with \\>= 2 grade peripheral neuropathy according to CTCAE V5.0 during screening, and those with any significant neurological dysfunction remaining.\n\n15\\. Those with a history of current active primary or secondary immunodeficiency diseases.\n\n16\\. Those with previous disseminated herpes zoster or herpes simplex. 17. Those with a history of significant pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, severe or poorly controlled asthma (except for mild intermittent asthma that does not require routine maintenance treatment).\n\n18\\. Select patients who need intravenous antibiotics for hospitalization within the past 30 days or who need oral antibiotic treatment for active bacterial, fungal, viral, mycobacterial infections or other infections within the past 14 days before screening.\n\n19\\. Select patients who have received any live or attenuated vaccines within the past 30 days before screening or who plan to receive any live or attenuated vaccines during the study period or within 30 days after the last administration.\n\n20\\. Select patients who have a history of active tuberculosis within the past 1 year before screening or who have a positive tuberculosis test result within the past 1 month before screening. These are defined as:\n\na. Have a history of active tuberculosis infection and no evidence of clinical cure; b. Have imaging evidence (such as chest CT) indicating active tuberculosis in the subject at the time of screening; c. Have suspicious tuberculosis symptoms that cannot be excluded by the investigator's assessment (such as low fever, cough, night sweats, weight loss, etc.); d. Latent tuberculosis infection (LTBI): Have a positive tuberculosis test result during the screening period, but no clinical symptoms or signs of active tuberculosis; Detection methods include but are not limited to T-spot test, QuantiFERON-TB Gold test, PPD test. If the subject has started LTBI preventive treatment according to the guideline-approved protocol before randomization and has been treated for at least 1 month, the subject is eligible. To continue the study, the subject must agree to complete the recommended treatment course for LTBI; e. The result of the tuberculosis test: If the result of the first test is uncertain, a second test should be conducted. If the retest result is still uncertain, the subject should be excluded from this study. If the retest is positive, the subject should receive LTBI treatment. If the retest is negative and does not meet other tuberculosis exclusion criteria, the subject is eligible.\n\n21\\. During the screening visit, abnormal results of blood routine tests were screened (repeated tests could be conducted for verification, and the decision was made independently by the researchers). The abnormalities included, but were not limited to:\n\na. White blood cell count \\\u003C 3.5 × 10\\^9\u002FL; b. Neutrophil count \\\u003C 1.5 × 10\\^9\u002FL; c. Lymphocyte count \\\u003C 0.8 × 10\\^9\u002FL; d. Platelet count \\\u003C 100 × 10\\^9\u002FL; e. Hemoglobin \\\u003C 9.0 g\u002FdL. 22. During the screening visit, abnormal results of blood biochemistry (repeated tests are allowed for verification, and the determination is made independently by the researchers), including but not limited to:\n\n1. Total bilirubin \\> 1.5 × upper limit of normal (ULN);\n2. AST \\> 1.5 × ULN;\n3. ALT \\> 1.5 × ULN. 23. With moderate or end-stage renal function impairment, including but not limited to:\n\na. Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2; b. Estimated creatinine clearance rate \\\u003C 60 mL\u002Fmin; c. Creatinine level \\> 1.4 mg\u002FdL or 123 μmol\u002FL (for female participants); d. Creatinine level \\> 1.6 mg\u002FdL or 141 μmol\u002FL (for male participants). 24. Exclude participants who have a history of alcohol abuse within the past 1 year (with weekly alcohol intake exceeding 21 units for men and 14 units per week for women (1 unit = 360 mL of beer; or 150 mL of wine; or 45 mL of liquor)) or a history of drug abuse.\n\n25\\. Accept those who have received any of the following treatments:\n\n1. Within 12 weeks before the first administration of the investigational drug:\n\n   1. Intravenous immunoglobulin or plasma exchange therapy;\n   2. Drugs known to have an impact on the cardiac conduction system (such as Class I or III anti-arrhythmic drugs);\n   3. Other biologics except dupilumab.\n2. Within 4 weeks before administration, those who have used long-acting anticoagulant drugs (such as warfarin, dabigatran, etc.) or those who need continuous anticoagulant drug treatment (except aspirin \\\u003C= 100 mg\u002Fday).\n3. Within 1 week before the first administration of the investigational drug.\n\n   1\\) Use antiplatelet drugs. Note: Based on the investigator's judgment, low-dose aspirin (dose \\\u003C= 100 mg, QD) for the purpose of preventing cardiovascular diseases is allowed; 26. Within 12 weeks before screening, those who have lost blood \\>= 400 mL (including trauma, blood collection, blood donation), or those who plan to donate blood during the study or within 1 month after the study.\n\n   27\\. Due to other reasons, unable to complete this study or considered unsuitable by the investigator.","75 Years",{"count":115,"type":22},111,[54],"This clinical trial aims to explore whether the drug ZL-82 tablets can be used to treat moderate to severe atopic dermatitis in adults, and to understand the safety and tolerability of the drug. The main questions that the trial intends to answer are: Can ZL-82 tablets alleviate the Eczema Area and Severity Index (EASI) score of patients? What physical problems will patients have after taking ZL-82 tablets? The researchers will compare ZL-82 tablets with placebo (a substance with a similar appearance but without drug components) to observe whether ZL-82 tablets can be used to treat moderate to severe atopic dermatitis. Participants need to take ZL-82 tablets or placebo every day for 16 weeks, and visit the hospital for a check-up every two weeks; record their own symptoms and the percentage change of EASI score relative to the baseline.",[119],"Atopic Dermatitis",[121],"ZL-82","2026-02-03",{"date":124,"type":33},"2026-02-04",{"date":122,"type":33},{"date":127,"type":22},"2028-06-30",{"name":39,"class":40},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":113,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":148,"locationsCount":41},"100619063","phase-1-a-clinical-study-of-zl-85fa-tablets-100619063","NCT07339748","A Clinical Study of ZL-85FA Tablets","An Open-label, Multicenter Phase I\u002FIIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ZL-85FA Tablets in Treating Advanced Solid Tumors","Inclusion Criteria:\n\n\\- 1.Voluntarily joining this study, signing informed consent form, good compliance, and able to cooperate with follow-up; 2.Age: \\>=18 years old and \\\u003C=75 years old (including boundary values, calculated on the day of signing informed consent), gender not limited; 3.Patients with advanced breast cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and prostate cancer confirmed by pathological histology or cytology.\n\n4.ECOG \\\u003C= 1 point; 5.Expected survival period \\>= 12 weeks; 6.Sufficient organ functio; 7. All acute toxicity reactions of previous anti-cancer treatments or surgical procedures have been relieved to baseline severity or NCI-CTCAE version 5.0 \\\u003C= 1 (except for hair loss or other toxicity that the researcher considers to be of no safety risk to the patient); 8.Women and men of childbearing age should agree to take effective contraceptive measures (hormone or barrier therapy or abstinence) 10.During the study period and within 6 months after the end of the study; Female patients of childbearing age who have a negative serum or urine pregnancy test within 7 days before administration and must be non lactating patients.\n\nExclusion Criteria:\n\n* 1.It is known that there is severe allergy to the investigational drug or any of its excipients (lactose, microcrystalline cellulose, low substituted hydroxypropyl cellulose, glyceryl behenate, hydroxypropyl methylcellulose, film coated premix (gastric soluble)); 2.Currently or previously suffering from other malignant tumors (excluding fully treated basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ), unless curative treatment has been carried out and there is evidence of no recurrence or metastasis within the past 5 years; 3.Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases requiring steroid treatment within 2 weeks prior to the first use of the study drug. Subjects with malignant meningitis or leptomeningeal spread; 4.Have received the last systemic anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, biologics, etc.) within 4 weeks before the first administration, with mitomycin or nitrosamines within 6 weeks, and small molecule targeted drugs within 2 weeks before the first administration of the study drug or within 5 half lives of the known drug (whichever is longer); Local palliative radiotherapy within 2 weeks prior to the first use of the study drug; The last administration of endocrine therapy is within 2 weeks before the first administration of the investigational drug (excluding necessary drug castration treatment for patients with metastatic castration resistant prostate cancer); Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications were received within 2 weeks before the first administration of the study drug; 5.Individuals with severe infections within 4 weeks prior to the first administration, or those with active infections requiring oral or intravenous antibiotic treatment within 2 weeks prior; Individuals with active pulmonary tuberculosis who have undergone sufficient treatment before their first medication and have stopped anti tuberculosis treatment for at least 3 months are eligible for enrollment; 6.Receive blood transfusion, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, granulocyte colony-stimulating factor and other treatments within 2 weeks before the first use of the investigational drug; 7.Patients who have received systemic corticosteroid (prednisone\\>10 mg\u002Fday or equivalent doses of similar drugs, continuously used for more than 4 days) or other immunosuppressive therapy within 14 days before the first administration; Excluding the following situations: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term prophylactic treatment with corticosteroids such as contrast agents.\n\n  8.There are uncontrollable or significant cardiovascular and cerebrovascular diseases, including:\n  1. Within 6 months prior to the first use of medication, there is a New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or arrhythmia requiring treatment during screening, with a left ventricular ejection fraction (LVEF)\\\u003C50%;\n  2. Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and undifferentiated cardiomyopathy);\n  3. Other cardiovascular and cerebrovascular diseases that have been determined by researchers to be unsuitable for inclusion.\n\n  9.Uncontrollable electrolyte imbalances may affect the efficacy of QTc drugs , but retesting after intervention therapy is allowed; 10.Those who have undergone major surgeries requiring general anesthesia or have not withdrawn from other clinical trials within 4 weeks prior to the first administration; Within 2 weeks prior to enrollment, the patient has undergone surgery requiring local anesthesia\u002Fepidural anesthesia and has not yet recovered (excluding tissue biopsy); 11.he following active infections with clinical significance, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as: subjects who are HBsAg positive or HBcAb positive and whose HBV DNA is higher than the lower limit of detection (i.e. the upper limit of the normal value in the laboratory of each research center), if they reach the negative level of HBV DNA after antiviral treatment and receive antiviral drugs at least 2 weeks before the first administration, those who are willing to continue to receive anti hepatitis B virus treatment during the study period are allowed to be included in the study. Active hepatitis C is defined as those who are HCV antibody positive and whose HCV RNA is higher than the lower limit of detection (the upper limit of the normal value). Treponema pallidum antibody (TP Ab) positive and syphilis non-specific antibody titer (RPR) positive; 12.History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 13.Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders; 14. Patients with bleeding tendency (for example, active peptic ulcer, recent hemorrhagic stroke \\[within 6 months before screening\\], proliferative diabetes retinopathy); 15.Within the first 4 weeks of enrollment, participated in other interventional clinical trials; 16.Other serious acute or chronic medical or psychiatric disorders or laboratory abnormalities that may increase the risk of participation in the study or increase the risk associated with the administration of the study drug, or interfere with the study results, as well as other situations where the researcher deems the patient unsuitable to participate in this study.",{"count":137,"type":22},51,[25,54],"An open-label, multicenter phase I\u002FIIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating advanced solid tumors",[141],"Advanced Solid Tumor","2026-01-13",{"date":144,"type":33},"2026-01-15",{"date":35,"type":22},{"date":147,"type":22},"2028-12-31",{"name":39,"class":40},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":41},"100593793","phase-3-a-phase-iii-clinical-study-of-purinostat-mesylate-for-injection-in-patients-with-diffuse-large-b-cell-lymphoma-100593793","NCT07011056","A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma","A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (R\u002FR DLBCL)","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender restrictions;\n2. Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);\n3. Participants must have measurable disease;\n4. ECOG≤2;\n5. Adequate organ function\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding;\n2. Previous history of transplantation;\n3. Double\u002FTriple Hit B cell lymphoma;\n4. Patient with known active infection, or reactivation of a latent infection;\n5. Any serious diseases that investigator deems inappropriate to participate.",{"count":157,"type":22},390,[77],"The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma.\n\n.The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg\u002Fm2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles.\n\n.Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.",[161],"Recurrent and Refractory Diffuse Large B-cell Lymphoma","2025-09-15",{"date":164,"type":33},"2025-09-19",{"date":166,"type":33},"2025-07-18",{"date":168,"type":22},"2029-06-30",{"name":39,"class":40},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":66},"100551233","phase-2-a-phase-ii-clinical-trial-of-flonoltinib-maleate-tablet-in-intermediate-high-risk-myelofibrosis-100551233","NCT06457425","A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis","An Open-Label, Positive Drug-Controlled, Parallel, Multicenter Phase II Clinical Trial of the Efficacy, Safety, and Pharmacokinetics of Flonoltinib Maleate Tablets in Patients With Intermediate to High-Risk Myelofibrosis","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender restrictions;\n2. Diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) according to IWG-MRT criteria;\n3. Evaluated as intermediate-2 or high-risk myelofibrosis according to the Dynamic International Prognostic Scoring System (DIPSS) risk classification;\n4. Expected survival ≥ 24 weeks;\n5. ECOG score of 0-2;\n6. Splenomegaly: palpable spleen edge reaching or exceeding 5 cm below the costal margin (distance from the intersection of the left midclavicular line and the left costal margin to the farthest point of the spleen); or not palpable due to body habitus (obesity) but confirmed by magnetic resonance imaging (MRI ) (or CT scan if necessary) at screening with spleen volume ≥ 450 cm³;\n7. Blasts in peripheral blood and bone marrow ≤ 10%; 8) Within 7 days before the first dose, absolute absolute neutrophil count (ANC )≥ 1.0×10\\^9\u002FL, platelet count ≥ 50×10\\^9\u002FL, hemoglobin (HGB )\\> 60 g\u002FL (participants should not have received growth factors, colony-stimulating factors, thrombopoietic agents, or platelet transfusions within 2 weeks before the baseline assessment prior to the first dose); 9) Major organ function basically normal within 7 days before the first dose; 10) Able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Previous anticancer treatment-related toxic reactions have not recovered to grade 1 or below (excluding alopecia and conditions specified in inclusion criteria 8 and 9), or have not fully recovered from previous surgery (major surgery within 4 weeks);\n2. Hypersensitivity, allergic to the investigational drug or its excipients;\n3. Previous intolerance or resistance to ruxolitinib;\n4. Use of JAK inhibitors within 4 weeks before the first dose;\n5. Any significant clinical and laboratory abnormalities that, in the investigator's opinion, affect safety evaluation;\n6. History of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident (excluding lacunar infarction), or pulmonary embolism within 6 months prior to screening;\n7. Impaired cardiac function or arrhythmic disease requiring treatment at screening;\n8. Any active infection requiring intravenous antibiotic treatment at screening;\n9. Active tuberculosis infection within 48 weeks prior to screening or latent tuberculosis infection indicated by tuberculosis-related tests during the screening period;\n10. Patients who have undergone splenectomy or received radiation therapy to the spleen area within 12 months before the first dose;\n11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, except for: a) HBV infection: Patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) with undetectable peripheral blood HBV-DNA (below the detection limit of the testing laboratory) can be enrolled; they must continue antiviral therapy and have HBV-DNA testing every 12 weeks and at the end of treatment (EOT); b) HCV seropositive patients with negative HCV RNA can be enrolled.\n12. Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab) (patients with positive Treponema pallidum antibody can have a titer test, and the investigator will determine eligibility based on comprehensive judgment);\n13. Patients with epilepsy or those using psychiatric drugs or sedatives at screening (excluding those used for sleep purposes);\n14. Pregnant or breastfeeding women, and patients with reproductive potential (male and female) who refuse to use contraceptive measures during the trial and for 6 months after the trial;\n15. Patients who have had another malignancy within 5 years before the first dose (excluding cured in-situ carcinoma and basal cell carcinoma of the skin);\n16. Patients with other severe diseases that, in the investigator's opinion, may affect safety or compliance;\n17. Patients who participated in other clinical trials of investigational drugs or medical devices within 1 month before the first dose and used the investigational drug or device;\n18. Use of any treatment for MF (other than JAK inhibitors) within 2 weeks or 5 half-lives (whichever is longer) before the first dose, any immunomodulatory agents (e.g., thalidomide), any immunosuppressants, ≥10 mg\u002Fday prednisone or equivalent biological potency corticosteroids, or growth factors (e.g., erythropoietin (EPO)) (Traditional Chinese medicine should be stopped 1 day before the first dose);\n19. Patients with a history of congenital or acquired bleeding disorders;\n20. Other factors that the investigator deems unsuitable for participation in the trial.",{"count":178,"type":22},75,[54],"This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)",[182],"MF,PMF,PPV-MF,PET-MF","2025-04-07",{"date":185,"type":33},"2025-04-10",{"date":187,"type":33},"2024-05-06",{"date":189,"type":22},"2026-07-06",{"name":39,"class":40},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":113,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":66},"100549225","phase-1-a-clinical-study-of-purinostat-mesylate-for-injection-in-patients-with-advanced-solid-tumors-100549225","NCT06431243","A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors","An Open, Multicenter Phase Ib\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Purinostat Mesylate for Injection in Combination Therapy for Advanced Solid Tumors","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria:\n\n1. Age: ≥18 years and ≤75 years, regardless of gender.\n2. At least one measurable lesion as defined by RECIST 1.1 during the screening period (for the breast cancer cohort in the dose-escalation phase, measurable lesions are not required if the participant has only bone metastases).\n3. Phase Ib:\n\nMonotherapy Dose-Escalation Phase:\n\n1. Monotherapy in Cohort A0 (Breast Cancer):\n\n   Histologically or cytologically confirmed locally advanced or metastatic breast cancer that has failed standard treatment, for which no standard treatment is available, or for which standard treatment is not suitable at the current stage.\n2. Monotherapy in Cohort B0 (Solid Tumors):\n\nHistologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment, for which no standard treatment is available, or for which standard treatment is not suitable at the current stage. This includes but is not limited to triple-negative breast cancer, colorectal cancer, and urothelial cancer.\n\nCombination Therapy Dose-Escalation Phase:\n\n1. Combination with Fulvestrant in Cohort A (Breast Cancer):\n\n   * Histologically or cytologically confirmed breast cancer in perimenopausal, premenopausal, or postmenopausal women with estrogen receptor (ER)-positive, progesterone receptor (PgR)-negative or positive, and non-HER2-positive (including HER2-negative and low-expression) disease.\n   * Participants must have progressed or recurred after at least one line of endocrine therapy (regardless of whether it was in the advanced, metastatic, or neoadjuvant chemotherapy setting), with up to two lines of prior chemotherapy allowed.\n   * Ineligible for surgical resection.\n   * Definition of menopause must meet one of the following criteria:\n\n     1. Previous bilateral oophorectomy;\n     2. Age 60 years or older;\n     3. Under 60 years old, with no chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy within the past year, and naturally postmenopausal for more than 12 months with serum follicle-stimulating hormone and estradiol levels in the postmenopausal range;\n     4. Under 60 years old, currently receiving tamoxifen or toremifene therapy, with serum follicle-stimulating hormone and estradiol levels within the postmenopausal range on two consecutive tests;\n     5. If the above criteria are not met, the participant is considered premenopausal or perimenopausal. Female participants must meet the following criteria: Initiation of luteinizing hormone-releasing hormone (LHRH) agonists such as goserelin or leuprorelin at least 28±2 days before the first dose of study drug (participants who have already been using LHRH agonists for ≥21 days and \\\u003C26 days before the first dose must have hormone levels meeting the criteria), and continued use of such drugs throughout the study treatment period.\n2. Combination with Tislelizumab in Cohort B (Solid Tumors):\n\n   * Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment, for which no standard treatment is available, or for which standard treatment is not suitable at the current stage.\n   * The definition of failure of standard treatment for each tumor type is as follows:\n\n     1. Non-small cell lung cancer: Metastatic patients without driver gene mutations: Progression or recurrence after at least second-line treatment (including platinum-based chemotherapy); Patients with tumors harboring EGFR, ROS1, ALK, or other driver gene mutations should have experienced failure of targeted therapy for these mutations and then progressed or recurred after at least second-line treatment (including platinum-based chemotherapy).\n     2. Small cell lung cancer: Progression or recurrence after at least second-line treatment.\n     3. Colorectal cancer: Progression or recurrence after at least second-line treatment (standard chemotherapy regimens previously received include fluorouracil or its derivatives, oxaliplatin, and irinotecan. Patients with BRAF V600E mutation should have received BRAF inhibitors. Patients with MSIH\u002FdMMR should have received PD-1\u002FPD-L1 therapy).\n     4. Head and neck squamous cell carcinoma: Progression or recurrence after at least second-line treatment (including platinum-based chemotherapy).\n     5. Urothelial cancer: Progression or recurrence after at least second-line treatment (recommended treatment regimens include PD-1\u002FPD-L1 therapy, platinum-based chemotherapy, taxane chemotherapy, Disitamab Vedotin, and vinflunine. Patients with FGFR2\u002F3 mutations should have received erdafitinib).\n     6. Esophageal cancer: Progression or recurrence after at least second-line treatment (including platinum-based chemotherapy).\n     7. Cervical cancer: Progression or recurrence after at least second-line treatment (including platinum-based chemotherapy. Patients with PD-L1 positivity, TMB-H, or MSI-H\u002FdMMR should have received PD-1\u002FPD-L1 therapy).\n     8. Hepatocellular carcinoma: Progression or recurrence after at least second-line treatment.\n     9. Renal cell carcinoma: Progression or recurrence after at least second-line treatment.\n\n        Phase IIa:\n\n        The tumor types and biomarker requirements for each expansion cohort in Phase IIa will be further determined based on data from Phase Ib and discussions with the Study Monitoring Committee (SMC).\n\n        4\\. ECOG performance status ≤1. 5. Life expectancy of ≥12 weeks. 6. Organ function levels must meet the following criteria:\n\n     \u003C!-- -->\n\n     1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n     2. Hemoglobin (HGB) ≥90 g\u002FL;\n     3. Platelet count (PLT) ≥100×10\\^9\u002FL;\n     4. Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin (according to the Cockcroft and Gault formula);\n     5. Serum total bilirubin (TBil) ≤1.5×ULN. For participants with liver metastases or Gilbert's syndrome, TBil \\>1.5×ULN is allowed if direct bilirubin (DBil) is \\\u003CULN. AST and ALT ≤2.5×ULN. For participants with liver metastases or Gilbert's syndrome, AST\u002FALT ≤5×ULN is allowed.\n\n        7\\. Willingness to participate in this study and provision of informed consent. 8. All acute toxicities from previous anticancer treatments or surgical procedures must have resolved to baseline severity or to NCI-CTCAE Version 5.0 ≤Grade 1 (except for alopecia or other toxicities deemed by the investigator to pose no safety risk to the participant).\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are not eligible for the trial:\n\n1. Known severe allergy to the investigational drug, any of the combination drugs, or any of their excipients (hydroxypropyl-beta-cyclodextrin, arginine, tromethamine, mannitol).\n2. Presence or history of other malignancies (except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ), unless the participant has undergone curative treatment and has evidence of no recurrence or metastasis within the past 5 years.\n3. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring corticosteroid treatment within 2 weeks before the first dose of the study drug. Participants with asymptomatic CNS metastases are also excluded. Participants with leptomeningeal carcinomatosis or meningeal dissemination are excluded.\n4. Participants with a history of anti-tumor treatment meeting the following criteria must be excluded:\n\n   1. Received mitomycin C or nitrosourea chemotherapy (e.g., carmustine, lomustine) within 6 weeks before the first dose.\n   2. Received systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, biological therapy) within 4 weeks before the first dose.\n   3. Received investigational drug treatment in a clinical trial or is currently participating in another clinical trial within 4 weeks before the first dose.\n   4. Received oral fluoropyrimidine or small-molecule targeted therapy within 2 weeks before the first dose or within 5 half-lives of the known drug (whichever is longer).\n   5. Received palliative local radiotherapy within 2 weeks before the first dose.\n   6. Received traditional Chinese medicine or patent Chinese medicine with anti-tumor indications within 2 weeks before the first dose.\n\n   Note: If a participant has received multiple treatments with different washout periods, the actual washout period will be determined by the longer duration.\n5. Participants who have previously received HDAC inhibitors.\n6. Participants who have previously received any estrogen receptor degraders, including but not limited to fulvestrant, are not eligible for the cohort combining with fulvestrant.\n7. Participants who have previously received anti-PD-1\u002FPD-L1 antibody treatment are not eligible for the cohort combining with tislelizumab, unless the participant has previously benefited from anti-PD-1\u002FPD-L1 treatment in the advanced\u002Fmetastatic setting and may be included.\n8. Participants with a severe infection within 4 weeks before the first dose of PM (Purinostat Mesylate), or those with active infections requiring oral or intravenous antibiotic treatment within the last 2 weeks.\n9. Participants who received transfusions, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoiesis-stimulating agents, or granulocyte colony-stimulating factors within 2 weeks before the first dose of the study drug.\n10. For breast cancer: Participants with symptomatic, visceral metastatic disease at high risk of life-threatening complications in the short term (patients with visceral crisis) or inflammatory breast cancer.\n11. Participants who experienced ≥Grade 3 immune-related adverse events during previous immunotherapy are not eligible for the cohort combining with tislelizumab.\n12. Participants with active or a history of autoimmune diseases that are at risk of recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) are not eligible for the cohort combining with tislelizumab. Exceptions include participants with Type I diabetes or autoimmune thyroiditis that can be managed with replacement therapy.\n13. Participants who received systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days before the first dose of PM are not eligible for the cohort combining with tislelizumab.\n\n    Exceptions include the use of topical, ocular, intra-articular, nasal, and inhaled corticosteroids, and short-term corticosteroids for prophylactic treatment (e.g., prior to contrast administration).\n14. Participants with uncontrolled or significant cardiovascular or cerebrovascular diseases, including:\n\n    1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first dose of PM, or arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) \\\u003C50% at screening.\n    2. Primary cardiomyopathies (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).\n    3. Symptomatic coronary artery disease requiring pharmacological treatment during the screening period.\n    4. History of clinically significant QTcF interval prolongation, or an average corrected QT interval (QTc) \\>450 msec (male) or \\>470 msec (female) based on three electrocardiograms (ECGs) during screening (repeat and average three values only if the first ECG shows QTc \\>450 msec (male) or \\>470 msec (female)); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmias, or current use of antiarrhythmic drugs or implantable defibrillators for ventricular arrhythmias.\n    5. Cerebrovascular accident (including intracerebral hemorrhage, cerebral infarction, transient ischemic attack) within 6 months before the first dose of PM.\n    6. Inadequately controlled blood pressure during the screening period (regardless of whether antihypertensive medication is being taken): systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.\n    7. Other cardiovascular or cerebrovascular diseases deemed by the investigator as unsuitable for enrollment.\n15. Uncontrolled electrolyte disturbances that may affect the action of QTc-prolonging drugs (e.g., hypocalcemia \\\u003C1.0 mmol\u002FL, hypokalemia \\\u003Clower limit of normal, hypomagnesemia \\\u003C0.5 mmol\u002FL), but retesting is allowed after intervention.\n16. Current or history of any severity of interstitial lung disease with significant impairment of pulmonary function.\n17. Presence of third-space effusions (e.g., pleural effusion, ascites) that cannot be controlled by drainage or other methods.\n18. Participants who underwent major surgery requiring general anesthesia within 4 weeks before the first dose of PM or have not withdrawn from other clinical trials; those who underwent surgery requiring local anesthesia\u002Fepidural anesthesia within 2 weeks before enrollment and have not recovered (except for tissue biopsy).\n19. Clinically significant active infections, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as participants who are HBsAg positive or HBcAb positive with HBV-DNA above the limit of detection (i.e., upper limit of normal for the laboratory of each center). If participants achieve HBV-DNA negativity after antiviral therapy and are willing to continue antiviral therapy during the study, they may be enrolled after receiving at least 2 weeks of antiviral treatment before the first dose. Active hepatitis C is defined as HCV antibody positive with HCV-RNA above the limit of detection (upper limit of normal). Positive Treponema pallidum antibody (TPAb) and positive non-treponemal antibody titer.\n20. History of immunodeficiency, including positive HIV antibody test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n21. Participation in another interventional clinical trial within 4 weeks before enrollment.\n22. Pregnant or breastfeeding women, or those who cannot ensure the use of contraception during the study and for at least 6 months after the last dose of Purinostat.\n23. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study or the risk associated with the administration of the study drug, or may interfere with the study results, as well as other situations where the investigator deems the patient unsuitable for participation in this study.",{"count":199,"type":22},132,[25,54],"Primary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors; and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of Purinostat Mesylate in combination therapy in patients with advanced solid tumors.\n\nTo determine the recommended Phase II dose (RP2D) of Purinostat Mesylate in combination therapy for advanced solid tumors.\n\nPhase IIa To further evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors.\n\nSecondary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate Monotherapy for the treatment of advanced solid tumors; To evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors; To evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for the treatment of advanced solid tumors.\n\nPhase IIa To further evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors.\n\nTo evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for advanced solid tumors.\n\nExploratory Objectives To assess the pharmacodynamic characteristics in Purinostat Mesylate combination therapy for advanced solid tumors.",[141],{"date":185,"type":33},{"date":205,"type":33},"2024-05-08",{"date":207,"type":22},"2026-11-01",{"name":39,"class":40},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":113,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":41},"100553341","phase-1-purinostat-mesylate-combined-with-pomalidomide-capsules-and-low-dose-dexamethasone-in-patients-with-relapsed-or-refractory-multiple-myeloma-100553341","NCT06484829","Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","An Open-Label, Parallel-Controlled, Multi-Center Phase Ib\u002FIIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Diagnosed with multiple myeloma (MM) by reference to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022);\n2. Those who have received at least one line of prior systemic antimyeloma therapy (which must include lenalidomide and proteasome inhibitors; see Appendix 4 for counts of myeloma treatment lines) and meet the definition of relapse or refractory; Definition of relapse: disease progression that occurs at least 60 days from the last treatment after the efficacy of a prior treatment regimen was evaluated at MR or better (except for those who relapsed more than 1 year after treatment); Definition of refractory: progression during prior therapy or progression within 60 days of the last treatment; or failure to achieve MR or better after at least 2 prior courses of therapy; or treatment intolerance.\n3. Age 18-75 years, male or female, if of childbearing potential subjects should be on effective contraception and must agree to comply with all contraceptive requirements:\n\n1\\) Females of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: beginning 4 weeks prior to treatment with this product, two reliable methods of contraception are required concurrently for the duration of the treatment, during the dose suspension, and for 4 weeks after termination of the treatment (one highly effective method of contraception-tubal ligation, intrauterine device, hormonal (contraceptive pills, injections, patches, vaginal rings, or implants), or partner's vasectomy, and another effective contraceptive method - male rubber or synthetic condom, diaphragm or cervical cap). Effective contraception is needed even with a history of infertility unless due to hysterectomy; 2) Men of childbearing potential must use a rubber or synthetic condom at all times during sexual contact with women of childbearing potential beginning 4 weeks prior to treatment with this product, during the treatment period, during the dose suspension period, and for 4 weeks after termination of treatment, even if they have had a successful vasectomy; 4. Subjects with multiple myeloma who have measurable M protein, i.e., at least one of the following 3 measurements:\n\n1. Serum M protein ≥ 0.5 g\u002FdL (5 g\u002FL);\n2. Urine M protein ≥ 200 mg\u002F24h;\n3. Serum free light chain assay: in the case of an abnormal serum free light chain ratio (less than 0.26 or greater than 1.65), an affected free light chain level ≥10mg\u002FdL (100mg\u002FL); 5. Hematologic fulfillment of the following conditions:\n\n1\\) ANC ≥ 1.0 x 109\u002FL (without granulocyte colony-stimulating factor within 7 days), with no specific requirement for neutrophil count when ≥ 50% of the bone marrow is plasma cells; 2) PLT ≥75 × 109\u002FL (no platelet transfusion or use of thrombopoietin within 7 days), and platelets ≥50 × 109\u002FL were eligible for enrollment when ≥50% of plasma cells were present in the bone marrow; 3) Hemoglobin ≥ 80 g\u002FL (no red blood cell suspension infusion or use of erythropoietin within 7 days); 6. Liver and kidney function tests fulfill the following conditions:\n\n1. TBIL ≤ 1.5 x ULN;\n2. ALT and AST are ≤ 2.5 x ULN;\n3. Glomerular filtration rate (GFR) ≥ 30mL\u002Fmin\u002F1.73m2 (Cockcroft-Gault formula) without the effects of dialysis therapy; 7. Ability to receive and have access to antithrombotic medications such as low molecular heparin sodium, heparin, warfarin or aspirin; 8. An ECOG (Appendix 2) score of 0-2 and an expected survival of ≥12 weeks; 9. Subjects voluntarily enrolled in the study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Those with prior antitumor therapy with histone deacetylase (HDAC) inhibitors (except cedarbenazine), antibody-coupled degradation agents (DAC), HSP90 inhibitors, or valproic acid; or those who, in the judgment of the investigator, are intolerant to treatment with the same type of drug as HDAC inhibitors, pomalidomide, thalidomide, lenalidomide, or the like (e.g., grade ≥3 rash during prior use, severe refractory myelosuppression, etc.);\n2. Those with disease progression following prior treatment with standard dose pomalidomide;\n3. Allergic reactions to the components of the test drug involved in this trial;\n4. A diagnosis of non-secretory MM (defined as a subject who is completely non-secretory or who has a small amount of free light chain but the affected light chain is less than 100 mg\u002FL), or MM in combination with amyloidosis, or plasma cell leukemia, either primary or during the course of therapy\n5. Those with active new thrombosis or who are unable to receive antithrombotic therapy;\n6. Other malignant tumors within 5 years prior to screening, with the exception of cured carcinoma in situ (e.g., cervix, breast, bladder, etc.), basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, or early-stage prostate carcinoma (with clinical staging of Tla or T1b);\n7. Those who have a combination of central nervous system disorders and require treatment for such disorders\n8. Peripheral neuropathy ≥ grade 3; and\n9. Co-morbidities requiring long-term treatment with immunosuppressive drugs or steroids; 10. active infectious diseases;\n10. Those with comorbid active infectious diseases, including the following:\n\n1\\) Hepatitis B Surface Antigen (HbsAg) or Hepatitis B Core Antibody (HbcAb) positive with HBV-DNA quantification higher than the upper limit of normal value 2) Positive Hepatitis C Virus Antibody (HCV-Ab) with HCV RNA quantification above the upper limit of normal; 3) Human immunodeficiency virus antibody (HIV-Ab) or anti-syphilis spirochete antibody (TP-Ab) positive; 11. Subjects with any of the following:\n\n1. Cardiac insufficiency ≥ grade 3 by NYHA classification (Appendix 1) criteria;\n2. Myocardial infarction within 6 months;\n3. Poorly controlled angina, including variant angina, within 6 months;\n4. Clinically significant arrhythmia;\n5. ECG QTcF \\>450 ms (men) and QTcF \\>470 ms (women) (Fridericia formula);\n6. Echocardiographic indication of left ventricular ejection fraction \\\u003C50%; 12. A combination of severe infectious disease requiring systemic intravenous antibiotic therapy 2 weeks prior to the first dose; 13. Those who have received an allogeneic hematopoietic stem cell transplant within 12 months, or those who have active graft-versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy more than 12 months after the allogeneic hematopoietic stem cell transplant; 14. Who have participated in another clinical trial within 4 weeks prior to the first dose; 15. Those who have received other antitumor therapy (including herbal antitumor therapy, except for ≤20 mg\u002Fday of prednisone and its equivalent dose of steroid hormones) within 2 weeks prior to the first administration of the drug; 16. Those who have not recovered to Grade 1 or below from toxic reactions to prior antitumor therapy (except alopecia, malaise and those limited by entry criteria #6); 17. Those who have received major surgical treatment within 4 weeks prior to the first dose and have not fully recovered; 18. Women who are pregnant or breastfeeding; 19. Persons who, in the opinion of the investigator, have other factors that make them unsuitable for participation in the trial (e.g., uncontrolled active hypertension, uncontrolled active diabetes mellitus, poor adherence, substance abuse, etc.).",{"count":217,"type":22},144,[25,54],"Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma.\n\nPhase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM).\n\nSecondary Objectives Phase Ib\n\n1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in the treatment of relapsed or refractory multiple myeloma.\n2. To assess the pharmacokinetic (PK) parameters of the combination therapy in patients with relapsed or refractory multiple myeloma.\n3. To observe the preliminary efficacy of the combination therapy in patients with relapsed or refractory multiple myeloma.\n\nPhase IIa\n\n1. To evaluate the preliminary efficacy of the combination therapy in patients with relapsed and refractory multiple myeloma (RRMM).\n2. To characterize the population pharmacokinetic (PPK) profile of the combination therapy in patients with relapsed or refractory multiple myeloma (RRMM).",[221],"Relapsed or Refractory Multiple Myeloma (RRMM)","2025-03-27",{"date":224,"type":33},"2025-04-02",{"date":226,"type":33},"2024-03-25",{"date":228,"type":22},"2026-04-01",{"name":39,"class":40},""]