[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Evopoint Biosciences Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":254},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,71,92,118,144,167,187,208,233],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100649159","phase-1-clinical-study-of-xnw5004-combined-with-chopchoep-in-the-treatment-of-untreated-peripheral-t-cell-lymphoma-100649159",false,"NCT07730515","Clinical Study of XNW5004 Combined With CHOP\u002FCHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","A Phase Ib\u002FII Clinical Study of XNW5004 Combined With CHOP\u002FCHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive); both genders are eligible.\n* Pathologically confirmed peripheral T-cell lymphoma (PTCL).\n* No prior systemic anti-PTCL therapy.\n* At least one measurable lesion as the basis for evaluation: nodal lesions with a long diameter \\> 1.5 cm; extranodal lesions with a long diameter \\> 1.0 cm.\n* Life expectancy of at least 12 weeks.\n* ECOG performance status score of 0-1.\n* Vital organ function reserves meet the following requirements:\n* Hematopoietic function:\n* White blood cell count \\>= 3.5 x 10\\^9\u002FL (no G-CSF administration within 1 week before the screening blood test, and no long-acting leukocyte-elevating agent administration within 2 weeks)\n* Platelet count \\>= 75 x 10\\^9\u002FL (no platelet transfusion or TPO receptor agonist administration within 1 week before the screening blood test)\n* Hemoglobin \\>= 80 g\u002FL (no red blood cell transfusion or EPO administration within 1 week before the screening blood test)\n* Hepatic function: serum total bilirubin \\\u003C= 1.5 x ULN (\\\u003C= 3 x ULN for Gilbert's syndrome), and ALT and AST \\\u003C= 2.5 x ULN; for subjects with liver infiltration, ALT\u002FAST \\\u003C= 5 x ULN; for subjects with liver and\u002For bone infiltration, alkaline phosphatase \\\u003C= 5 x ULN\n* Renal function: serum creatinine \\\u003C= 1.5 x ULN or estimated creatinine clearance \\>= 60 mL\u002Fmin according to the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* International normalized ratio (INR) \\\u003C= 1.5 x ULN, or prothrombin time (PT) and activated partial thromboplastin time (APTT) \\\u003C= 1.5 x ULN\n* Women of childbearing potential must have a negative serum pregnancy test before entering this study and agree to use effective contraception from the start of the study until at least 6 months after the last dose of the investigational drug. Female subjects who are not capable of childbearing must have been naturally amenorrheic for at least 12 months and be confirmed by a specialist physician as having no reproductive function based on female hormone testing; or have undergone bilateral oophorectomy, hysterectomy, or tubal ligation at least 6 weeks prior to screening. Male subjects must agree to use adequate contraceptive measures from the start of the study until at least 6 months after the last dose of the investigational drug, and must not donate sperm.\n* Provide a signed and dated written informed consent form prior to undergoing study-specific procedures, and be able to comply with clinical visits and study-related procedures.\n\nExclusion Criteria:\n\n* Prior treatment with any anti-tumor therapy, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or anti-tumor investigational drugs.\n* Subjects with known hypersensitivity to the investigational drug or its active ingredients or excipients.\n* Subjects who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug, or who plan to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).\n* Prior or planned allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Receipt of steroid hormones for anti-tumor purposes (daily dose \\> 20 mg prednisone or equivalent dose of other glucocorticoids) within 7 days prior to the first dose of the investigational drug; or diseases requiring systemic treatment with steroid hormones (daily dose \\> 10 mg prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the first dose of the investigational drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a daily dose \\\u003C= 10 mg prednisone or equivalent dose of other glucocorticoids are permitted.\n* Subjects who have taken known moderate or strong CYP3A4 inhibitors\u002Finducers within 14 days prior to the first dose.\n* Receipt of live virus vaccine (including attenuated live vaccine) within 28 days prior to dosing. Inactivated vaccines are permitted.\n* History of psychotropic substance abuse or drug addiction.\n* History of other malignancies within 3 years prior to enrollment that do not meet clinical cure criteria. The following are exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n* Mycosis fungoides, Sezary syndrome, and primary cutaneous T-cell lymphoma.\n* Presence of central nervous system involvement.\n* Presence of testicular or breast involvement.\n* Prior or current hemophagocytic syndrome.\n* Prior or current immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematological diseases that may affect bone marrow function other than the primary malignancy.\n* Prior or current acute myeloid leukemia (AML).\n* Prior or current T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL).\n* History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory markers associated with MDS or myeloproliferative neoplasm (MPN).\n* Prior or concomitant central nervous system disorders, including but not limited to: epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc.\n* Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n* Acute myocardial infarction within 12 months prior to the first dose\n* Unstable angina pectoris\n* Congestive heart failure (New York Heart Association functional class III or IV)\n* Uncorrected serious arrhythmia, hypertension \\>= 150\u002F100 mmHg\n* Prolonged QTc interval (defined as \\> 450 ms for males and \\> 470 ms for females, by Fredericia's formula)\n* Prior history of other major cardiovascular diseases (e.g., valve replacement, coronary artery bypass grafting, etc.)\n* Tumor invasion of surrounding vital organs and blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) with risk of bleeding, or risk of tracheoesophageal fistula or esophagopleural fistula.\n* Subjects with clinically symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment.\n* Active severe systemic infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether administered intravenously or orally); a washout period of at least 1 week is required after completion of other intravenous anti-infective therapy; other oral anti-infective therapies must be discontinued before the first dose of the investigational drug.\n* Active tuberculosis under treatment.\n* HIV-positive or syphilis (Anti-TP) positive subjects (subjects with negative syphilis non-specific antibody test results and judged by the investigator to have been cured of syphilis are not excluded).\n* HBsAg positive with HBV-DNA copy number above the lower limit of normal detection, or HBcAb positive with HBV-DNA copy number above the lower limit of normal detection; HCV antibody positive with HCV-RNA copy number above the lower limit of normal detection.\n* Subjects who are unable to swallow, or have active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or a history of gastrectomy or gastric banding that may affect drug absorption. However, gastroesophageal reflux treated with proton pump inhibitors is permitted (if there is no potential for drug interaction).\n* Known hemorrhagic diathesis such as von Willebrand disease or hemophilia.\n* Females who are pregnant or breastfeeding.\n* Subjects who may not be able to complete the study for other reasons or whom the investigator considers should not be enrolled.","ALL","18 Years","75 Years",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","In this study, the XNW5004 tablets combined with CHOP\u002FCHOEP will be used for the treatment of newly diagnosed PTCL patients.",[28,29],"Non-hodgkin Lymphoma","Peripheral T-cell Lymphoma",[31,32],"EZH2 inhibitor","XNW5004","RECRUITING","2026-07-27",{"date":36,"type":37},"2026-07-29","ACTUAL",{"date":39,"type":37},"2025-08-15",{"date":41,"type":21},"2028-09-30",{"name":43,"class":44},"Evopoint Biosciences Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100649239","phase-2-study-of-xnw5004-tablets-in-advanced-prostate-cancer-100649239","NCT07730580","Study of XNW5004 Tablets in Advanced Prostate Cancer","An Open-Label, Multicenter Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of XNW5004 Tablets in Combination With Anti-Tumor Therapy in Participants With Advanced Prostate Cancer","XNW5004 Tablet","1. Signed written informed consent prior to initiation of any study activity\u002Fprocedure;\n2. Male, ≥18 years of age;\n3. Expected survival ≥ 3 months;\n4. ECOG performance status score of 0-1;\n5. Histologically or cytologically confirmed prostate adenocarcinoma of a single pathological type, excluding neuroendocrine carcinoma or small cell carcinoma;\n6. Bone metastatic lesions confirmed by bone scan, or soft tissue metastatic lesions confirmed by CT\u002FMRI, with at least one evaluable lesion according to RECIST 1.1 and PCWG3 criteria. \\*Note:\\* Isolated regional lymph node metastasis alone does not qualify for study participation;\n7. Continuous luteinizing hormone-releasing hormone agonist (LHRHa) or antagonist therapy (medical castration), or prior bilateral orchiectomy (surgical castration); participants who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the entire study period;\n8. Castrate level of testosterone at screening (≤50 ng\u002FdL or 1.7 nmol\u002FL);\n9. Disease progression at screening, defined as meeting one or more of the following three criteria while receiving castration therapy: ① PSA progression, defined as PSA \\>1 ng\u002FmL with at least 2 consecutive PSA elevations separated by ≥1 week; ② Disease progression per RECIST 1.1; ③ Bone disease progression per PCWG3 criteria, defined as ≥2 new lesions identified on bone scan;\n10. Prior antitumor therapy meets the following requirements:\n\n    1. Phase Ib:\n\n       * Cohort 1 (combination with abiraterone + prednisone for mCRPC):\\* Prior failure of novel hormonal therapy other than abiraterone acetate - defined as disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the setting of mCSPC or mCRPC, or disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the non-metastatic setting or within 3 months after completing such therapy; disease progression is defined as per Inclusion Criterion 9.\n       * Cohort 2 (combination with docetaxel + prednisone for mCRPC):\\* Metastatic castration-resistant prostate cancer with prior failure of at least one novel hormonal therapy; failure of novel hormonal therapy is defined as per Cohort 1.\n    2. Phase II:\n\n       * Cohort 1 (combination with abiraterone + prednisone for mCRPC):\\* Prior failure of novel hormonal therapy other than abiraterone acetate - defined as disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the setting of mCSPC or mCRPC, or disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the non-metastatic setting or within 3 months after completing such therapy; disease progression is defined as per Inclusion Criterion 9.\n       * Cohort 2 (combination with abiraterone + prednisone for mCSPC):No prior systemic antitumor therapy other than androgen deprivation therapy (ADT) and first-generation antiandrogens. Prior ADT (medical or surgical castration) for up to 3 months is allowed, with no evidence of radiographic disease progression or PSA elevation prior to Cycle 1 Day 1.\n       * Cohort 3 (combination with docetaxel + prednisone for mCRPC):Metastatic castration-resistant prostate cancer with prior failure of at least one novel hormonal therapy; failure of novel hormonal therapy is defined as per Cohort 1.\n       * Cohort 4 (combination with enzalutamide for mCSPC):No prior systemic antitumor therapy other than androgen deprivation therapy (ADT) and first-generation antiandrogens. Prior ADT (medical or surgical castration) for up to 3 months is allowed, with no evidence of radiographic disease progression or PSA elevation prior to Cycle 1 Day 1.\n       * Cohort 5 (combination with other agents):Participants with advanced prostate cancer who have failed prior therapy other than the agent class of interest (to be specified via protocol amendment prior to cohort initiation).\n11. Participant laboratory values meet the following requirements:\n\n    1. Hepatic function assessment:\n\n       * Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases);\n       * Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases);\n       * Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for Gilbert's syndrome).\n    2. Renal function assessment:\\*\\*\n\n       * Creatinine clearance ≥ 60 mL\u002Fmin (per Cockcroft and Gault formula, Appendix 20.3), or serum creatinine ≤ 1.5 × ULN.\n    3. Hematology assessment:\\*\\*\n\n       * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL (no granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week, and no long-acting G-CSF within 2 weeks prior to screening CBC) - for non-docetaxel combination cohorts; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (no G-CSF within 1 week, and no long-acting G-CSF within 2 weeks prior to screening CBC) - for docetaxel combination cohorts;\n       * Platelets ≥ 75 × 10⁹\u002FL (no platelet transfusion and no thrombopoietin \\[TPO\\] within 1 week prior to screening CBC);\n       * Hemoglobin ≥ 8 g\u002FdL (80 g\u002FL) (no red blood cell transfusion and no erythropoietin \\[EPO\\] within 1 week prior to screening CBC).\n    4. Coagulation assessment:\n\n       * Prothrombin time (PT) \\\u003C 1.5 × ULN, or international normalized ratio (INR) \\\u003C 1.5 × ULN; if the participant is currently on anticoagulant therapy, INR ≤ 3 × ULN.\n12. Must agree to use adequate contraception from study initiation through at least 6 months after the last dose of study drug, and must refrain from sperm donation;\n13. Able to comply with all study procedures as judged by the investigator.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will not be eligible for enrollment in this study:\n\n1. Prior antitumor therapy meets the following conditions:\n\n   1. Phase Ib:\n\n      * Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to antibody-drug conjugates \\[ADCs\\] with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 2: Prior cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload) at any stage of prostate cancer. \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n   2. Phase II:\n\n      * Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 2:Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.\n      * Cohort 3:Participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 4: Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.\n2. Prior treatment with agents similar to or targeting the same pathway as the study drug (including but not limited to tazemetostat, EZH1\u002F2 inhibitors, and EED inhibitors);\n3. Received chemotherapy, immunotherapy, definitive radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or other anti-tumor therapies within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; palliative radiotherapy within 2 weeks prior to the first dose;\n4. Planned receipt of any other anti-tumor therapy during the study period;\n5. Received any other investigational product not yet approved in the study region within 28 days prior to the first dose of this study (i.e., last dose of investigational product within 28 days of the first study drug dose);\n6. Presence of central nervous system (CNS) metastases; history of or concurrent CNS conditions including but not limited to epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, spinal cord compression, or cauda equina syndrome (with the exception of stroke that was adequately treated and stable for ≥12 months prior to first dose, or asymptomatic\u002Funtreated lacunar infarction);\n7. Severe bone damage due to tumor bone metastases as judged by the investigator, including poorly controlled severe bone pain, pathological fractures at critical sites occurring within the last 6 months or expected in the near future, and spinal cord compression;\n8. History of other malignancy within 3 years prior to enrollment that does not meet clinical cure criteria. Exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that has been locally treated and cured, superficial bladder cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n9. Poorly controlled bladder outlet obstruction or urinary incontinence as judged by the investigator;\n10. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n    1. Acute myocardial infarction or unstable angina ≤ 6 months prior to first dose;\n    2. Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV), left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    3. Uncorrected serious arrhythmia, hypertension ≥ 150\u002F100 mmHg;\n    4. Prolonged QTc interval (defined as \\>450 ms for males, \\>470 ms for females) per Fridericia's formula (see Appendix 20.4);\n    5. History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.);\n11. Active systemic severe infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether intravenous or oral); at least 1 week washout after completion of other intravenous anti-infective therapy; other oral anti-infective therapy must meet discontinuation criteria and be stopped prior to the first study dose;\n12. History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate anti-tuberculosis treatment;\n13. Known hypersensitivity to the study drug or its active ingredients or excipients;\n14. Use of known moderate or strong CYP3A inducers or inhibitors within 14 days prior to the first dose (see Appendix 20.5);\n15. Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis; with the exception of Type 1 diabetes mellitus, hypothyroidism controlled solely by replacement therapy, hyperthyroidism stable on medication, and skin conditions not requiring systemic therapy (e.g., vitiligo, localized psoriasis);\n16. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active ILD;\n17. Known gastrointestinal (GI) function impairment or GI conditions that may significantly affect the absorption or metabolism of oral medications; abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n18. Human immunodeficiency virus (HIV) positive, or syphilis (Anti-TP) positive (not excluded if non-treponemal syphilis test is negative and the investigator determines syphilis has been cured);\n19. Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive with HBV DNA ≥ 200 IU\u002FmL or ≥ 10³ copies\u002FmL), or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive);\n20. Toxicities from prior anti-tumor therapy that have not resolved (not recovered to ≤ Grade 1 per NCI-CTCAE Version 6.0). Exceptions include other toxicities that the investigator deems do not affect participant safety assessment (e.g., alopecia);\n21. Symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment;\n22. Prior allogeneic tissue or solid organ transplantation;\n23. Major surgery within 4 weeks prior to dosing, or planned major surgery during the study period (excluding procedures such as puncture or lymph node biopsy);\n24. Received live virus vaccine (including live attenuated vaccine) within 28 days prior to dosing; inactivated vaccines are allowed;\n25. Baseline bone scan showing a \"superscan\" pattern that precludes assessment of new bone metastases;\n26. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","MALE",{"count":56,"type":21},242,[25],"Phase Ib A preliminary design of 2 cohorts is planned for this phase, with 3-6 participants to be enrolled in each cohort. A total of 6-12 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.\n\nPhase II A preliminary design of 5 cohorts is planned for this phase. Cohorts 1, 2, and 3 are preset with 2 dose groups each, and each dose group plans to enroll 20-30 participants. Cohort 4 plans to enroll 20-50 participants. Cohort 5 will be adjusted based on results from prior study phases. A total of 140-230 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.",[60],"Advanced Prostate Cancer",[32,60],"NOT_YET_RECRUITING","2026-07-22",{"date":65,"type":37},"2026-07-28",{"date":67,"type":21},"2026-07-13",{"date":69,"type":21},"2028-12-31",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100647508","phase-1-phase-i-open-label-randomized-multicenter-study-of-xnw28012-monotherapy-in-metastatic-pancreatic-cancer-100647508","NCT07707674","Phase I Open-Label Randomized Multicenter Study of XNW28012 Monotherapy in Metastatic Pancreatic Cancer","A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects With Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. subjects with histologically or cytologically confirmed metastatic PDAC, whose disease has progressed after at least 1 prior systemic therapy.\n2. Age ≥ 18 years old at the time of consent.\n3. Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrantsdiscussion with the medical monitor.\n4. Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the following laboratory values;\n5. Life expectancy of at least 12 weeks.\n6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug.\n7. Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized.\n8. Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.\n\n   \\-\n\nExclusion Criteria:\n\n1. A history of severe infusion reactions to other monoclonal antibodies\u002Fantibody drug conjugates (ADCs), or allergic reactions to any components of XNW28012, or treatment with TF-directed therapy.\n2. Any anti-tumor therapy within 21 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.\n3. Any active malignancy, with the exception of the specific types of cancersunder investigation in this study and any locally recurring cancer that has been treated curatively .\n4. Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.\n5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte \u002F macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening.\n6. Subjects with toxicities (as a result of prior anti-cancer therapy) that have not improved to CTCAE grade ≤ 1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia).\n7. Any history of pneumonitis or interstitial lung disease (ILD).\n8. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.\n9. Any hematological risk factors.\n10. Clinically significant cardiovascular\u002Fcerebrovascular conditions.\n11. Subjects have known active CNS metastases and\u002For carcinomatous meningitis.\n12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis, or corneal nebula; subjects with glaucoma of CTCAE grade ≥ 2.\n13. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome.\n14. Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive.\n15. Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is higher than 500 IU\u002FmL or subjects with positive hepatitis C virus (HCV) RNA. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C subjects may be enrolled.\n16. A known history of HIV infection or acquired immunodeficiency syndrome (AIDS).\n17. Subjects with severe chronic or active infections requiring antibacterial, antifungal or antiviral therapy.\n18. Known immunodeficiency or any condition that requires systemic treatment with either corticosteroids (≥ 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days before the first dose of study drug.\n19. Subjects who have received (or plan to receive during the study treatment period) strong\u002Fmoderate CYP3A4 inhibitors or inducers, or strong\u002Fmoderate CYP2D6 inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n20. Have an ongoing significant, uncontrolled medical condition.\n21. Subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study.\n22. Underlying medical conditions or alcohol, drug abuse or dependence that, in Investigator's opinion, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or adverse events, or insufficient compliance during the study according to Investigator's judgment.",{"count":79,"type":21},24,[24],"A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects with Metastatic Pancreatic Cancer",[83],"Metastatic Pancreatic Cancer","2026-07-21",{"date":63,"type":37},{"date":87,"type":21},"2026-07-30",{"date":89,"type":21},"2028-04-30",{"name":43,"class":44},8,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":45},"100634893","phase-2-clinical-study-of-xnw5004-tablets-in-the-treatment-of-relapsed-and-refractory-follicular-lymphoma-100634893","NCT07545603","Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma","Phase II Study of XNW5004 in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma (EZH2 Wild-type)","Inclusion Criteria:\n\n1. Age ≥ 18 years; no gender restriction.\n2. Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study site.\n3. Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a commercially available anti-CD20 monoclonal antibody and at least one line with adequate treatment using a novel agent (including but not limited to PI3K inhibitors, CD3×CD20 bispecific antibodies, BTK inhibitors, etc.):\n\n   Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criterion may be included only with a valid justification (e.g., intolerance).\n\n   Adequate novel agent treatment: failure to achieve response, disease progression during treatment, or treatment discontinuation due to intolerance (intolerance defined as meeting treatment discontinuation criteria per the package insert).\n\n   Relapsed disease: relapse ≥6 months after achieving response to any line of therapy.\n\n   Refractory disease, defined by any of the following:\n\n   Response duration \\\u003C6 months and ineligible for or unwilling to undergo autologous hematopoietic stem cell transplantation (auto-HSCT); Failure to achieve response after at least 4 cycles of treatment; Best response or treatment discontinuation due to progressive disease, regardless of number of cycles; Relapse after auto-HSCT.\n4. Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.\n5. Availability of sufficient biological samples for EZH2 mutation testing.\n6. At least one measurable lesion: nodal lesion with longest diameter \\>1.5 cm; extranodal lesion with longest diameter \\>1.0 cm and FDG-PET positive.\n7. Life expectancy ≥12 weeks.\n8. ECOG performance status 0 or 1.\n\n   Adequate organ function:\n\n   Hematologic function:\n9. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL (≥1.0×10⁹\u002FL if bone marrow involvement); no G-CSF within 1 week or long-acting G-CSF within 2 weeks before screening CBC.\n\n   Platelets ≥90×10⁹\u002FL (≥75×10⁹\u002FL if bone marrow involvement); no platelet transfusion or TPO receptor agonist within 1 week before screening CBC.\n\n   Hemoglobin ≥90 g\u002FL (≥80 g\u002FL if bone marrow involvement); no red blood cell transfusion or EPO within 1 week before screening CBC.\n\n   Hepatic function:\n\n   Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); ALT and AST ≤2.5×ULN; ≤5×ULN with liver involvement; ALP ≤5×ULN with liver and\u002For bone involvement.\n\n   Renal function:\n\n   Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin by Cockcroft-Gault equation.\n\n   Left ventricular ejection fraction (LVEF) ≥50%. INR ≤1.5×ULN, or PT and APTT ≤1.5×ULN.\n10. Women of childbearing potential must have a negative serum pregnancy test at study entry and agree to use highly effective contraception from study start until at least 6 months after last dose of study drug.\n\n    Non-childbearing potential is defined as:\n\n    Amenorrhea ≥12 months with confirmation of menopausal status by hormonal testing and specialist assessment; OR Bilateral oophorectomy, hysterectomy, or tubal ligation ≥6 weeks before screening.\n\n    Male subjects must agree to use effective contraception and refrain from sperm donation from study start until at least 6 months after last dose of study drug.\n11. Signed and dated written informed consent prior to any study-specific procedures, and ability to comply with study visits and protocol-required assessments.\n\nExclusion Criteria:\n\n1. Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.\n2. Prior treatment with an EZH2 inhibitor or EZH1\u002F2 inhibitor (including but not limited to tazemetostat).\n3. Known hypersensitivity to the investigational product, its active ingredients, or excipients.\n4. Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received CAR-T therapy within 12 weeks prior to the first dose; underwent autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.\n5. Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.\n6. Underwent major surgery within 4 weeks prior to initiation of study treatment, or planning major surgery during the study period (excluding procedures such as puncture or lymph node biopsy).\n7. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n8. Disease requiring systemic therapy with corticosteroids (\\> 10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement therapy with ≤ 10 mg prednisone daily or equivalent are permitted in the absence of active autoimmune disease.\n9. Received moderate or strong CYP3A4 inhibitors\u002Finducers within 14 days prior to the first dose (see Appendix 4 for details).\n10. Received live or live-attenuated viral vaccines within 28 days prior to dosing. Inactivated vaccines are permitted.\n11. History of psychoactive substance abuse or drug addiction (except for insomnia with stable, long-term therapy as assessed by the investigator).\n12. Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 per NCI-CTCAE version 5.0, except for toxicities deemed by the investigator not to affect patient safety evaluation (e.g., alopecia).\n13. History of another malignancy within 3 years prior to enrollment that does not meet criteria for clinical cure, except for adequately treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n14. Previous or current central nervous system involvement by lymphoma.\n15. Previous or current testicular or breast involvement by lymphoma.\n16. Previous or current hemophagocytic lymphohistiocytosis.\n17. Previous or current primary or secondary hematologic disorders other than the primary malignant neoplasm that may affect bone marrow function, including immune thrombocytopenia, autoimmune hemolytic anemia, and aplastic anemia.\n18. Previous or current acute myeloid leukemia (AML).\n19. Previous or current T-lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia (T-ALL).\n20. History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory findings associated with MDS or myeloproliferative neoplasms (MPN).\n21. Previous or current central nervous system disorders including, but not limited to: epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc. (excluding stroke with adequate treatment and stable disease for ≥12 months before first dose, or asymptomatic lacunar infarction not requiring treatment).\n22. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n    Acute myocardial infarction within 12 months prior to first dose; Unstable angina; Congestive heart failure (NYHA Class III or IV, see Appendix 5); Uncontrolled serious arrhythmia, hypertension ≥ 150\u002F100 mmHg; Prolonged QTcF interval (\\> 450 ms in males, \\> 470 ms in females) calculated by Fredericia's formula (see Appendix 6); History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.).\n23. Tumor invasion of adjacent vital organs, gastrointestinal tract, or blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of hemorrhage, or risk of esophagotracheal fistula, esophagopleural fistula, gastrointestinal perforation, etc.\n24. Clinically symptomatic pleural effusion, ascites, or pericardial effusion poorly controlled despite repeated treatment.\n25. Unexplained fever with body temperature \\> 38.0 °C (including tumor fever); body temperature must be within normal range for 2 weeks prior to first dose.\n26. Systemic active severe infection: at least 2 weeks washout after completion of antifungal therapy (intravenous or oral), at least 1 week washout after completion of other intravenous antimicrobial therapy, and oral antimicrobial therapy must be discontinued prior to first dose.\n27. History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without adequate anti-tuberculosis treatment.\n28. Positive HIV test or positive syphilis (Anti-TP) test (patients with negative non-treponemal test and syphilis deemed cured by the investigator are not excluded).\n29. Positive HBsAg with HBV-DNA above the lower limit of detection, or anti-HBc positive with HBV-DNA above the lower limit of detection; positive HCV antibody with HCV-RNA above the lower limit of detection.\n30. Inability to swallow, or active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or history of gastrectomy, gastric banding, or other conditions affecting drug absorption. Proton pump inhibitor-treated gastroesophageal reflux is permitted if no potential drug-drug interaction exists.\n31. Known bleeding disorders such as von Willebrand disease or hemophilia.\n32. Female patients who are pregnant or breastfeeding.\n33. Patients who may be unable to complete the study for any other reason, or whom the investigator deems ineligible for enrollment.",{"count":100,"type":21},65,[25],"This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type).\n\nThe study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up.\n\nFor long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.",[104,105,106,107],"Follicular Lymphoma, Grade 1","Follicular Lymphoma, Grade 2","Follicular Lymphoma, Grade 3","Follicular Lymphoma Grade 3A",[109,110],"Follicular Lymphoma","Phrase II","2026-04-21",{"date":113,"type":37},"2026-04-22",{"date":115,"type":37},"2026-02-14",{"date":69,"type":21},{"name":43,"class":44},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":79},"100577541","phase-1-study-of-xnw28012-in-subjects-with-advanced-solid-tumors-who-failed-standard-treatments-100577541","NCT06799637","Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments","A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Efficacy of XNW28012 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. For the dose escalation part: subjects with histologically or cytologically confirmed advanced and\u002For metastatic solid tumors who have failed the established standard anti-cancer therapies for a given tumor type or have been intolerant to such therapies.\n2. For the dose expansion part: subjects must have a histological or cytological diagnosis of progressive, locally advanced, and\u002For metastatic ovarian cancer, cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed the following anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer.\n3. Age ≥ 18 years old at the time of consent.\n4. Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).\n5. Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrants discussion with the medical monitor.\n6. Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the flaboratory values:\n7. Life expectancy of at least 12 weeks.\n8. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n9. Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized.\n10. Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. A history of severe infusion reactions to other monoclonal antibodies\u002Fantibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.\n2. Any anti-tumor therapy within 28 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.\n3. Any active malignancy, with the exception of the specific types of cancers under investigation in this study and any locally recurring cancer that has been treated curatively .\n4. Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.\n5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte \u002F macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening.\n6. Subjects with toxicities (as a result of prior anti-cancer therapy) which have not improved to CTCAE grade ≤1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia).\n7. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.\n8. Any of the hematological risk factors:\n9. Subjects who are unwilling or unable to provide tumor tissue samples that meet the requirements for tissue factor (TF) expression testing.\n\n11\\. Clinically significant cardiovascular\u002Fcerebrovascular conditions. 12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis.\n\n13\\. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome. 14. Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter \\[PICC\\] line).\n\nand so on.",{"count":126,"type":21},350,[24,25],"This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.",[130,131,132,133],"Advanced Solid Tumors","Pancreatic Carcinoma","Ovarian Cancer","Cervical Cancers",[135],"XNW28012","2026-04-14",{"date":138,"type":37},"2026-04-15",{"date":140,"type":37},"2023-12-01",{"date":142,"type":21},"2026-12-31",{"name":43,"class":44},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":45},"100575797","phase-3-a-randomized-double-blind-multicenter-phase-iii-study-of-xnw5004-tablets-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-100575797","NCT06776952","A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* Aged 18-70 years (inclusive)，gender not limited.\n* Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.\n* Disease status defined as relapsed or refractory after \\>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK\u002FT-cell lymphoma require treatment with a regimen containing asparaginase\u002Fprotease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin.\n* Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.\n* Having at least one measurable lesion for evaluation.\n* Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements.\n* Life expectancy of at least 12 weeks.\n* Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Have adequate organ function.\n* Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug.\n* Able to provide written informed consent form prior to the commencement of any study activity\u002Fprocedure.\n\nExclusion Criteria:\n\n* Prior exposure to EZH2 inhibitor(s) or EZH1\u002F2 inhibitor(s).\n* Prior exposure to HDAC inhibitor(s).\n* Subjects with known hypersensitivity to the study drug or its active ingredients or excipients.\n* Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug.\n* Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.\n* Subjects who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy).\n* Subjects who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Subjects who have received systemic treatment with corticosteroids (prednisone at a dose of \\> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with prednisone at a dose of ≤ 10 mg per day or equivalent doses of other glucocorticoids are permitted.\n* Subjects taking known strong CYP3A4 inhibitors\u002Finducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose.\n* Subjects who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted.\n* Subjects with a history of psychotropic drug abuse or drug abuse.\n* Subjects who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia, etc.) that do not affect the safety evaluation of subjects in the opinion of the investigator.\n* Subjects with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally.\n* Subjects with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma.\n* Subjects with previous or current central nervous system invasion.\n* Subjects with previous or current testicular or breast invasion.\n* Subjects with previous or current hemophagocytic syndrome.\n* Subjects with previous or current primary or secondary hematologic diseases that may affect bone marrow function in addition to primary malignancies, such as immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, etc.\n* Subjects with previous or current acute myeloid leukemia (AML).\n* Subjects with previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia.\n* Subjects who have any history of myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal tests results of markers related to MDS or myeloproliferative neoplasm (MPN).\n* Subjects who previously hadcentral nervous system lesions, or diseases accompanies with central nervous system lesions, including but not limited to, epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, cerebral organic syndrome, or psychosis, etc.\n* Subjects with clinically significant cardiovascular disease.\n* Tumor invasion of important peripheral organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) posing a risk of bleeding or the risk of esophageal tracheal fistula or esophageal pleural fistula.\n* Subjects with clinically symptomatic thoracoabdominal effusion or pericardial effusion that are poorly controlled after repeated treatment.\n* Subjects with unexplained fever and body temperature\\>38.0 ℃.\n* Subjects who have severe active systemic infection.\n* Subjects with a history of tuberculosis infection within one year prior to enrollment, or with a history of active tuberculosis infection more than one year ago without sufficient anti tuberculosis treatment.\n* A known history of HIV infection or acquired immunodeficiency syndrome (AIDS), or Anti- Treponema Pallidum test (anti-TP) positive.\n* Subjects who have HBV-DNA copy numbers higher than the lower normal limit of the detection value. Subjects with HCV-RNA copy number higher than the lower normal limit of the detection value.\n* Subjects who are unable to swallow or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or has undergone gastrectomy or gastric banding that affects drug absorption. But gastroesophageal reflux that has been treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction).\n* Subjects with conditions known to have bleeding tendencies, such as von Willebrand disease or hemophilia.\n* Subjects who are pregnant or breastfeeding, or expects to conceive within the projected duration of the study.\n* Subject who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not participate the study.","18 Days","70 Days",{"count":153,"type":21},120,[155],"PHASE3","This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed\u002FRefractory PTCL, with a target of enrolling 120 subjects.",[158],"Relapsed\u002FRefractory Peripheral T Cell Lymphoma","2026-01-07",{"date":161,"type":37},"2026-01-09",{"date":163,"type":37},"2025-04-10",{"date":165,"type":21},"2028-04",{"name":43,"class":44},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":45},"100618105","phase-1-a-phase-iii-study-to-evaluate-xnw34017-in-patients-with-advanced-or-metastatic-solid-tumor-100618105","NCT07327294","A Phase I\u002FII Study to Evaluate XNW34017 in Patients With Advanced or Metastatic Solid Tumor","An Open-label, Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of XNW34017 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose escalation phase: Subjects with advanced and\u002For metastatic malignant solid tumors who have failed standard treatment or lack effective standard treatment, and have histologically or cytologically confirmed diagnosis.\n2. Dose expansion phase, including but not limited to: Advanced and\u002For metastatic small cell lung cancer, prostate cancer, etc., with disease progression confirmed by histopathology, and failure in the following anti-cancer treatments:\n\n   Small cell lung cancer: Patients with small cell lung cancer who have progressed or relapsed after receiving at least two prior systemic treatment regimens.\n\n   Metastatic castration-resistant prostate cancer (mCRPC): Patients who have previously received treatment with enzalutamide or abiraterone and have experienced disease progression. At screening, serum testosterone should be at castration levels (≤ 50 ng\u002FdL or ≤ 1.73 nmol\u002FL). For patients who have not undergone bilateral orchiectomy, LHRHa therapy should be administered ≥ 4 weeks prior to the first dose of study treatment and continued throughout the study.\n3. The subject must be ≥ 18 years of age at the time of signing the informed consent.\n4. At least one measurable lesion according to RECIST 1.1 criteria (applicable to the backfill cohort and dose expansion phase).\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n6. The subject's organ function levels must meet the following requirements within 7 days prior to the first dose:\n\n   Absolute Neutrophil Count (ANC) ≥ 1.5×10\\^9\u002FL, Platelet Count ≥ 100×10\\^9\u002FL, Hemoglobin ≥ 90 g\u002FL; Creatinine Clearance ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault formula) or Serum Creatinine (Cr) ≤ 1.5 times the upper limit of normal; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), for liver cancer\u002Fliver metastasis patients, AST\u002FALT should be ≤ 5×ULN; Total Bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), for patients with Gilbert's Syndrome, Direct Bilirubin (DBIL) must be ≤ 2×ULN; International Normalized Ratio (INR) ≤ 1.2 (without anticoagulant treatment), Activated Partial Thromboplastin Time (APTT) ≤ 1.25×ULN; for subjects who have been on stable-dose anticoagulant therapy (e.g., warfarin) for ≥8 weeks, INR must be ≤3.\n7. Life expectancy ≥ 12 weeks.\n8. Female participants of childbearing potential must undergo a urine or serum pregnancy test within 7 days prior to starting the study medication, and the result must be negative. If the urine pregnancy test is positive or inconclusive, a serum pregnancy test must be performed.\n9. During the study and for 6 months after the last dose of the study drug, an effective, medically approved contraception method (e.g., intrauterine device, contraceptive pills, or condoms) must be used. For male participants with a female partner of childbearing potential, they must either be surgically sterilized or agree to use an effective contraception method during the study and for 6 months after the last dose of the study drug. Additionally, male participants must agree not to donate sperm throughout their study participation and for at least 6 months after their last dose of study drug.\n10. The participant has given informed consent and has signed the informed consent form, and is willing and able to comply with the study procedures required by the protocol.\n\nExclusion Criteria:\n\n1. Individuals who have had an allergic reaction to any component of the XNW34017.\n2. The washout period of prior antitumor treatments before the first study drug treatment is insufficient, defined as follows:\n\n   Chemotherapy, small molecule targeted therapy, or endocrine therapy \\\u003C 2 weeks or 5 half-lives, whichever is shorter; Monoclonal antibody therapy \\\u003C 3 weeks; Brain radiotherapy \\\u003C 2 weeks, palliative radiotherapy \\\u003C 2 weeks, curative radiotherapy \\\u003C 4 weeks.\n3. Subjects with double primary malignant tumors, except for the specific cancer being studied in this trial and any previously cured local tumors: non-invasive basal cell carcinoma or squamous cell carcinoma, non-invasive superficial bladder cancer, and any other tumors with a complete remission (CR) lasting more than 5 years.\n4. Receiving a live vaccine within 4 weeks prior to the first study drug treatment. Note: Seasonal flu vaccines are generally inactivated vaccines and can be used; however, intranasal flu vaccines, which are live attenuated vaccines, are not permitted.\n5. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte\u002Fmacrophage colony-stimulating factor within 1 week prior to the first study drug treatment, or use of pegylated G-CSF within 2 weeks prior to the first study drug treatment. Receiving blood transfusion treatment within 2 weeks prior to the first study drug treatment. Use of erythropoietin (EPO) or IL-11 within 1 week prior to the first study drug treatment.\n6. Subjects who have not yet recovered from the toxicity of prior anticancer treatments to CTCAE grade ≤ 1 or a stable condition, except for AEs that are not considered to pose a safety risk (e.g., hair loss).\n7. A history of intracranial arteriovenous malformation, cerebral aneurysm, or stroke (including transient ischemic attack within 1 month prior to screening, but excluding old cerebral infarction and asymptomatic cerebral infarction).\n8. Presence of any of the following hematologic risk factors:\n\n   Known coagulation defects leading to an increased risk of bleeding; Diffuse alveolar hemorrhage caused by vasculitis; Persistent major bleeding; Trauma resulting in an increased risk of life-threatening bleeding; A history of severe extracranial injury or intracranial surgery within 8 weeks prior to the start of the trial.\n9. Unable to provide tumor tissue samples for biomarker expression testing (for subjects unable to provide tissue samples, enrollment may be determined through consultation between the investigator and the sponsor).\n10. Presence of clinically significant cardiovascular or cerebrovascular diseases:History of unstable angina;Myocardial infarction within 6 months prior to screening;Underwent angioplasty or coronary stent treatment within 6 months prior to screening;History of congestive heart failure with New York Heart Association (NYHA) classification of 3 - 4;Baseline QTc interval abnormality (QTcF \\> 450 ms);Occurrence of ≥ grade 2 ventricular arrhythmia within 6 months prior to screening;Poorly controlled hypertension: systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg despite standard antihypertensive treatment;Presence of cardiac disease\u002Fhistory that results in left ventricular ejection fraction (LVEF) \\\u003C 50%.",{"count":175,"type":21},150,[24,25],"This study is an open-label, dose-escalation, multicenter Phase I\u002FII study conducted in patients with advanced solid tumors. The target population for this study consists of patients with advanced solid tumors who have failed or are intolerant to standard treatments. The study is divided into two parts: the dose-escalation phase and the dose-expansion phase.",[130],"2025-12-25",{"date":181,"type":37},"2026-01-08",{"date":183,"type":21},"2026-01-31",{"date":185,"type":21},"2028-06-30",{"name":43,"class":44},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":45},"100591982","phase-1-a-study-of-parg-inhibitor-xnw29016-in-patients-with-advanced-solid-tumors-who-failed-standard-treatment-100591982","NCT06987500","A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of XNW29016 Tablets in Advanced Solid Tumors With Failed Standard Treatment","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent form (ICF).\n* Age at the time of consent ≥ 18 years;\n* Life expectancy of ≥ 3 months;\n* For prostate adenocarcinoma, at least one evaluable lesion by RECIST v1.1 and PCWG3 criteria; for other advanced solid tumor, at least one measurable lesion by RECIST v1.1 criteria.\n* Agree to provide tumor tissue samples that meet the testing requirements;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;\n* Phase Ia：Patients with advanced solid tumor confirmed by histological or cytological examination,who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening, and must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug. Male patients must agree to take adequate contraceptive measures from the beginning of the study to at least 6 months after the last dose of the test drug, and prohibit sperm donation;\n* Ability to comply with all procedures of the clinical trial protocol.\n\nExclusion Criteria:\n\n* Any previous treatment with a PARG inhibitor.\n* Subjects known to be allergic to the study drug or its active ingredients or excipients;\n* Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;\n* Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;\n* Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);\n* Subjects who have an allogeneic tissue\u002F solid organ transplantation;\n* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;\n* Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure.\n* Central nervous system metastasis or disease;\n* Subjects who have impaired heart functions or clinically serious heart disease；\n* Have severe systemic active infection;\n* Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;\n* Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;\n* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);\n* Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;\n* Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;\n* Active autoimmune and inflammatory diseases；\n* Women who are pregnant or breastfeeding；\n* Subjects who are considered unsuitable for the study judged by the investigator.",{"count":195,"type":21},132,[24,25],"The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .",[199],"Tumor, Solid","2025-06-03",{"date":202,"type":37},"2025-06-06",{"date":204,"type":37},"2025-04-11",{"date":206,"type":21},"2027-08-16",{"name":43,"class":44},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100570111","phase-1-study-of-xnw5004-tablet-in-combination-with-enzalutamide-in-subjects-with-metastatic-castration-resistant-prostate-cancer-100570111","NCT06702995","Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer","A Phase Ib\u002FII Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Failed Prior Novel Hormone Therapy","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent form (ICF).\n* Age at the time of consent ≥ 18 years;\n* Life expectancy of ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;\n* Prostate adenocarcinoma confirmed by histological or cytological examination, except neuroendocrine carcinoma or small cell carcinoma;\n* Metastatic prostate cancer disease, documented by CT\u002FMRI imaging\u002Fbone scan ;\n* Ongoing luteinizing hormone-releasing hormone agonist (LHRHa) or antagonist therapy (medical castration) or prior bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must be scheduled for Maintain effective LHRHa therapy throughout the study period;\n* Testosterone at castration level (≤50ng\u002FdL or 1.7nmol\u002FL) at screening;\n* Progressive disease in the setting of medical or surgical castration for study entry, the subject has 1 or more of the following 3 items: (1) PSA progression, defined as PSA \\> 1ng\u002Fml and at least 2 episodes of PSA level elevation ≥ 1 week apart; (2) disease progression as defined by RECIST 1.1; (3) bone disease progression as defined by PCWG3 criteria, i.e., ≥ more than 2 new lesions found on bone scan;\n* Previous anti-tumor therapy meet the following conditions： Ib and IIb: Failure of previous abiraterone acetate therapy (refers to disease progression during abiraterone acetate treatment; disease progression is defined as the same as in Article 9 of the enrollment criteria), and no next generation androgen receptor inhibitors (enzalutamide or apalutamide, etc.) have been used; IIb: Failure of previous only one approved novel hormone therapy, such as abiraterone acetate, apalutamide, darolutamide and rezvilutamide, etc., except enzalutamide；\n* Adequate hematologic and non-hematologic function during the screening.\n* Must agree to take adequate contraceptive measures from the beginning of the study to at least 3 months after the last dose of the test drug, and prohibit sperm donation;\n* Ability to comply with all procedures of the clinical trial protocol.\n\nExclusion Criteria:\n\n* Previous anti-tumor therapy meet the following conditions： Ib and IIb: previously received any next generation androgen receptor antagonists (such as enzalutamide, apalutamide, proxalutamide and rezvilutamide, etc.) ； IIa: previously received with enzalutamide or more than 1 novel hormone therapy;\n* Prior chemotherapy for castration resistant disease (including but not limited to ADCs);\n* Prior exposure to EZH2 inhibitor(s) (including but not limited to tazemetostat and EZH1\u002F2 inhibitors);\n* Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;\n* Plan to receive any other anti-tumor therapy during this trial;\n* Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;\n* Central nervous system metastasis or disease;\n* Severe bone injury caused by tumor bone metastasis judged by the investigator, including severe bone pain with poor control, pathological fractures of important sites and spinal cord compression that occurred in the past 6 months or are expected to occur in the near future, etc.;\n* Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure. This exclusion criterion does not apply to skin basal cell carcinoma or squamous cell carcinoma with local treatment methods available and has been cured, superficial bladder cancer, intraductal breast carcinoma in situ, and papillary thyroid carcinoma;\n* Subjects who experienced stroke or other serious cerebrovascular diseases within 12 months prior to enrollment;\n* Subjects who have impaired heart functions or clinically serious heart disease；\n* Have severe systemic active infection;\n* Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;\n* Subjects known to be allergic to the study drug or its active ingredients or excipients;\n* Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;\n* Active autoimmune and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc., except type I diabetes, Hypothyroidism that can be controlled by replacement therapy alone, hyperthyroidism that is stable under drug control, skin diseases that do not require systemic therapy (eg, vitiligo, psoriasis);\n* Past medical history of interstitial lung disease (ILD), history of drug-induced ILD, history of radiation pneumonitis requiring steroid therapy, or evidence of any clinically active ILD;\n* Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;\n* Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;\n* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);\n* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;\n* Subjects who have clinically symptomatic and uncontrollable pleural or pericardial effusions after multiple times of treatments;\n* Subjects who have an allogeneic tissue\u002F solid organ transplantation;\n* Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);\n* Subjects who have received live vaccines (including attenuated live vaccines) within 28 days prior to the administration of study drug. Inactivated vaccines are permitted.\n* A superscan as seen in the baseline bone scan；\n* Subjects who are considered unsuitable for the study judged by the investigator.",{"count":216,"type":21},307,[24,25],"In this phase Ib\u002FII study, participants with metastatic castration-resistant prostate cancer (mCRPC) who failed prior novel hormone therapy will be treated with XNW5004 in combination with enzalutamide.",[220,221],"Metastatic Castrate-Resistant Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[32,223],"Enzalutamide","2025-04-17",{"date":226,"type":37},"2025-04-20",{"date":228,"type":37},"2023-04-19",{"date":230,"type":21},"2026-07-19",{"name":43,"class":44},2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100570081","phase-2-to-evaluate-xnw5004-tablets-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-100570081","NCT06702605","To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma","A Phase II Clinical Study of XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma","Inclusion Criteria:\n\n* Aged 18-70 years (inclusive)，gender not limited.\n* Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.\n* Disease status defined as relapsed or refractory after \\>=2 prior systemic treatment lines, including at least one new drug; subjects with CD30 positive ALCL requires prior treatment with Brentuximab vedotin.\n* Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.\n* Having at least one measurable lesion for evaluation.\n* Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements.\n* Life expectancy of at least 12 weeks.\n* Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Have adequate organ function as defined in the following requirements.\n* Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug.\n* Able to provide written informed consent form prior to the commencement of any study activity\u002Fprocedure.\n\nExclusion Criteria:\n\n* Prior exposure to EZH2 inhibitor(s) or EZH1\u002F2 inhibitor(s);\n* Subjects with known hypersensitivity to the study drug or its active ingredients or excipients.\n* Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug.\n* Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.\n* Subjects who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy).\n* Subjects who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Subjects who have received systemic treatment with corticosteroids (prednisone at a dose of \\> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with prednisone at a dose of ≤ 10 mg per day or equivalent doses of other glucocorticoids are permitted.\n* Subjects taking known strong CYP3A4 inhibitors\u002Finducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose.\n* Subjects who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted.\n* Subjects with a history of psychotropic drug abuse or drug abuse.\n* Subjects who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia, etc.) that do not affect the safety evaluation of subjects in the opinion of the investigator.\n* Subjects with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally.\n* Subjects with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma.\n* Subjects with previous or current central nervous system invasion.\n* Subjects with previous or current testicular or breast invasion.\n* Subjects with previous or current hemophagocytic syndrome.\n* Subjects with previous or current primary or secondary hematologic diseases that may affect bone marrow function in addition to primary malignancies, such as immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, etc.\n* Subjects with previous or current acute myeloid leukemia (AML).\n* Subjects with previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia.\n* Subjects who have any history of myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal tests results of markers related to MDS or myeloproliferative neoplasm (MPN).\n* Subjects who previously hadcentral nervous system lesions, or diseases accompanies with central nervous system lesions, including but not limited to, epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, cerebral organic syndrome, or psychosis, etc.\n* Subjects with clinically significant cardiovascular disease;\n* Tumor invasion of important peripheral organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) posing a risk of bleeding or the risk of esophageal tracheal fistula or esophageal pleural fistula.\n* Subjects with clinically symptomatic thoracoabdominal effusion or pericardial effusion that are poorly controlled after repeated treatment.\n* Subjects with unexplained fever and body temperature\\>38.0 ℃.\n* Subjects who have severe active systemic infection.\n* Subjects with a history of tuberculosis infection within one year prior to enrollment, or with a history of active tuberculosis infection more than one year ago without sufficient anti tuberculosis treatment.\n* A known history of HIV infection or acquired immunodeficiency syndrome (AIDS), or Anti- Treponema Pallidum test (anti-TP) positive.\n* Subjects who are HBsAg positive and have HBV-DNA copy numbers higher than the lower normal limit of the detection value, or subjects who are anti HBc positive and have HBV-DNA copy numbers higher than the lower normal limit of the detection value. Subjects with HCV antibody positive and HCV-RNA copy number higher than the lower normal limit of the detection value.\n* Subjects with difficulties to swallow the study drug or conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, clinically symptomatic inflammatory bowel disease, or incomplete\u002Fcomplete intestinal obstruction.\n* Subjects who are unable to swallow or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or has undergone gastrectomy or gastric banding that affects drug absorption. But gastroesophageal reflux that has been treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction).\n* Subjects with conditions known to have bleeding tendencies, such as von Willebrand disease or hemophilia.\n* Subjects who are pregnant or breastfeeding, or expects to conceive within the projected duration of the study.\n* Subject who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not participate the study.","70 Years",{"count":242,"type":21},50,[25],"This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R\u002FR PTCL. The study plans to enroll approximately 50 subjects.",[158],"2024-11-22",{"date":248,"type":37},"2024-11-25",{"date":250,"type":21},"2024-11",{"date":252,"type":21},"2027-01",{"name":43,"class":44},""]