[{"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:":245},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,74,97,118,139,166,192,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634893","phase-2-clinical-study-of-xnw5004-tablets-in-the-treatment-of-relapsed-and-refractory-follicular-lymphoma-100634893",false,"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.","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29],"Follicular Lymphoma, Grade 1","Follicular Lymphoma, Grade 2","Follicular Lymphoma, Grade 3","Follicular Lymphoma Grade 3A",[31,32],"Follicular Lymphoma","Phrase II","RECRUITING","2026-04-21",{"date":36,"type":37},"2026-04-22","ACTUAL",{"date":39,"type":37},"2026-02-14",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"Evopoint Biosciences Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"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":54,"type":20},350,[56,23],"PHASE1","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.",[59,60,61,62],"Advanced Solid Tumors","Pancreatic Carcinoma","Ovarian Cancer","Cervical Cancers",[64],"XNW28012","2026-04-14",{"date":67,"type":37},"2026-04-15",{"date":69,"type":37},"2023-12-01",{"date":71,"type":20},"2026-12-31",{"name":43,"class":44},24,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"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":83,"type":20},120,[85],"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.",[88],"Relapsed\u002FRefractory Peripheral T Cell Lymphoma","2026-01-07",{"date":91,"type":37},"2026-01-09",{"date":93,"type":37},"2025-04-10",{"date":95,"type":20},"2028-04",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"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":105,"type":20},150,[56,23],"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.",[59],"NOT_YET_RECRUITING","2025-12-25",{"date":112,"type":37},"2026-01-08",{"date":114,"type":20},"2026-01-31",{"date":116,"type":20},"2028-06-30",{"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":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"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":126,"type":20},132,[56,23],"The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .",[130],"Tumor, Solid","2025-06-03",{"date":133,"type":37},"2025-06-06",{"date":135,"type":37},"2025-04-11",{"date":137,"type":20},"2027-08-16",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":146,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},"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.","MALE",{"count":148,"type":20},307,[56,23],"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.",[152,153],"Metastatic Castrate-Resistant Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[155,156],"XNW5004","Enzalutamide","2025-04-17",{"date":159,"type":37},"2025-04-20",{"date":161,"type":37},"2023-04-19",{"date":163,"type":20},"2026-07-19",{"name":43,"class":44},2,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":45},"100576987","phase-1-xnw27011-study-of-advanced-solid-tumor-subjects-who-failed-standard-therapies-100576987","NCT06792435","XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.","A Phase I\u002FⅡ, First-in-Human Study of XNW27011 in Patients with Locally Advanced And\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n* Phase I (Dose Escalation)：\n\n  1. Patients are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n  2. Age ≥18 years old when signing the informed consent form.\n  3. Patients with a histologically or cytologically-confirmed, locally advanced or metastatic solid tumor, which has failed on standard therapy or is intolerable to available standard therapy, or there is no available standard therapy for the tumor. The advanced solid tumors include but are not limited to gastric and gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma, esophageal adenocarcinoma, ovarian cancer, lung cancer, colorectal cancer, andbiliary tract cancer.\n  4. The enrollment is not restricted to patients with tumor expressing CLDN18.2. However patients are required to provide tumor tissue sections for CLDN18.2 expression confirmation.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n  6. Estimated life expectancy \\> 12 weeks.\n  7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n  8. Adequate organ function, evidenced by the following laboratory results:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n     2. Platelet count ≥ 100 × 109\u002FL.\n     3. Hemoglobin ≥ 9.0 g\u002FdL.\n     4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n     5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN (if liver metastases are present, ≤ 3 × ULN).\n     6. Creatinine clearance (Ccr) ≥60 mL\u002Fminute as calculated using themodified Cockcroft-Gault equation.\n     7. QTc prolongation to ≤480 milliseconds (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n     8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n  9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\n     1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n     2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n  10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control during the study, and for 180 days after the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nPHASE Ⅱ (DOSE EXTENSION)：\n\n1. Subjects are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n2. Age ≥18 years old when signing the informed consent form.\n3. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, which have failed on standard therapy, or are intolerable to available standard therapy, or for which there is no available standard therapy.\n\n   Patients are grouped by anatomic locations of solid tumors:\n\n   Group A: gastric adenocarcinoma\u002Fgastroesophageal junction adenocarcinoma. Group B: pancreatic adenocarcinoma. Group C: ovarian cancer. Group D: other cancer including esophagus adenocarcinomas, lung cancer, colorectal cancer, and biliary tract cancer.\n4. Only patients with tumor expressing CLDN 18.2 will be enrolled. The most recently available tumor samples of patients will be examined by IHC at a central laboratory. If no archived tumor samples are available or the archived tumor samples are deemed to be inappropriate for the confirmation of CLDN18.2 expression, a new biopsy must be performed to obtain the tumor sample to confirmation of CLDN18.2 expression.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Estimated life expectancy \\> 12 weeks.\n7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n8. Adequate organ function, evidenced by the following laboratory results:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9.0 g\u002FdL.\n   4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5× ULN (if liver metastases are present, ≤ 3 × ULN).\n   6. Creatinine clearance (Ccr) ≥50 mL\u002Fminute as calculated using the modified Cockcroft-Gault equation.\n   7. QTc prolongation to ≤ 480 millisecond (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n   8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study and for at least 180 days following the last dose of study medication.\n\n   1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n   2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control for 180 days following the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* PHASE I (DOSE ESCALATION)：\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or at present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the tests, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes(HbA1c\\>8%).\n     4. History of or currently suffering from uncontrolled primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of the XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection. Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     10. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapy or biological therapy,) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception of tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011 or plan to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002F ligation, bilateral salpingectomy, or bilateral oophorectomy in the past, or women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator. PHASE Ⅱ (DOSE EXTENSION)：\n\n  \u003C!-- -->\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the study, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes (HbA1c\\>8%).\n     4. Previously or currently suffering from uncontrollable primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection.\n\n        Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Has multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.\n     10. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     11. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2, or participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapyor biological therapy) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Have received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception for tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011or planned to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002Fligation, bilateral salpingectomy, or bilateral oophorectomy in the past and women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator.",{"count":174,"type":20},240,[56,23],"This is a global, multi-center, open-label, Phase I\u002FII first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and\u002For metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and\u002For metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.",[178,179,61,180,181,182,183],"Pancreatic Adenocarcinoma Metastatic","Lung Cancer (NSCLC)","Colorectal Cancer Metastatic","Biliary Tract Cancer","Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma","2025-02-05",{"date":186,"type":37},"2025-02-07",{"date":188,"type":37},"2023-07-27",{"date":190,"type":20},"2025-12-31",{"name":43,"class":44},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"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":201,"type":20},50,[23],"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.",[88],"2024-11-22",{"date":207,"type":37},"2024-11-25",{"date":209,"type":20},"2024-11",{"date":211,"type":20},"2027-01",{"name":43,"class":44},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":233,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":45},"100517839","phase-1-study-of-xnw5004-tablet-in-combination-with-keytruda-pembrolizumab-in-subjects-with-advanced-solid-tumors-who-failed-standard-treatments-keynote-f19-100517839","NCT06022757","Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)","A Phase Ib\u002FII Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)","Inclusion Criteria:\n\n* Sign informed consent form prior to the commencement of any research activity\u002Fprocedure.\n* Age ≥ 18.\n* Cohort 3 (mCRPC cohort) is male-only, and no gender restrictions for other cohorts.\n* Subjects with advanced solid tumors who meet one of the following requirements can be enrolled in the study. No cohorts planned for the Phase Ib study, whereas the Phase II study is divided into 6 cohorts:\n\n  * Cohort: 1 Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including nasopharyngeal carcinoma),has progressed after treatment with a standard regimen containing PD-1\u002FPD-L1 inhibitors.\n  * Cohort 2: Histologically confirmed advanced urothelial carcinoma (including urothelial carcinoma of bladder, renal pelvis, ureter, and urethral origin) that is not suitable for surgical treatment and has progressed after treatment with a standard regimen containing PD-1\u002FPD-L1 inhibitors.\n  * Cohort 3:\n\n    1. Metastatic castration-resistant prostate adenocarcinoma with histological or cytological evidence of disease progression except neuroendocrine or small cell carcinoma; Imaging examination (CT\u002FMRI\u002F bone scan) confirmed metastatic lesions.\n    2. Failed previous standard treatments, and at least received one second-generation anti-androgen drug treatment (including but not limited to abiraterone acetate, enzalutamide or apalutamide).\n    3. Disease progression at screening.\n    4. Continuous luteinizing hormone-releasing agonist (LHRHa) or antagonist therapy (drug castration) or prior bilateral orchiectomy (surgical castration).\n    5. Testosterone at screening was at castration level.\n  * Cohort 4: Subjects with histologically or cytologically confirmed extensive-stage small cell lung cancer with disease progression after first-line standard therapy.\n  * Cohort 5: Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.\n\n    1. Cohort 5a: Previous use of and resistant to EGFR inhibitors and failed standard treatment.\n    2. Cohort 5b: No driver gene mutations identified and failed standard therapy containing PD-1\u002FPD-L1 inhibitors.\n  * Cohort 6: Subjects with advanced solid tumors other than those described in the above cohorts, and failed standard therapy. For recurrent or metastatic cervical cancer, it should be histologically or cytologically confirmed as squamous cell carcinoma, progressed after systematic standard treatment, and is not suitable for radical therapy .\n* For patients who have progressed on treatment with PD-1\u002FPD-L1 inhibitors administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, PD-1\u002FPD-L1 inhibitor treatment progression is defined by meeting all of the following criteria:\n\n  1. Has received at least 2 doses of approved PD-1\u002FPD-L1 inhibitors.\n  2. Documented objective radiographic progression following initiation of treatment with a PD-1\u002FPD-L1 inhibitor. Subjects should not be enrolled if they are suspected of permanent withdrawal due to pseudo-progression after previous PD-1\u002FPD-L1 inhibitor treatment.\n* To the extent possible, provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue section (previously archived or fresh) samples and blood samples that meet the detection requirements for exploratory studies.\n* Life expectancy ≥ 3 months.\n* At least one measurable lesion according to RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Have adequate organ function.\n* Females of child-bearing potential and males who use adequate birth control through 6 months post last dose.\n\nExclusion Criteria:\n\n* Cohort-specific exclusion criteria:\n\n  1. Cohort 1 (head and neck squamous cell carcinoma cohort)\n\n     * Neuroendocrine carcinoma and small cell carcinoma.\n     * Salivary adenocarcinoma or other non squamous cell carcinoma (such as adenocarcinoma, sarcoma or mixed carcinoma) confirmed by histology or cytology, and metastatic squamous cell carcinoma with unknown primary origin. This exclusion criterion is not applicable to nasopharyngeal cancer.\n  2. Cohort 3 (mCRPC)\n\n     * Severe bone injury caused by tumor bone metastasis, including severe, uncontrolled bone pain as judged by the investigator, bone fractures or spinal cord compression at critical parts of the body that occurred in the last 6 months or are expected to occur in a near future.\n     * Any previous treatment targeting T-cell co-stimulation or checkpoint pathways.\n  3. Cohort 5 (non-small cell lung cancer)\n\n     * Any previous treatment targeting T-cell co-stimulation or checkpoint pathways other than PD-1 \u002F PD-L1 inhibitors.\n     * Combined with other targetable driver mutations either alone or in addition to EGFR, including but not limited to: ALK gene rearrangement, ROS1 mutations, BRAFV600E mutation, etc. (For cohort 5a only.)\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.\n* Prior exposure to EZH2 inhibitor(s) or EZH1\u002F2 inhibitor(s) (including but not limited to tazemetostat).\n* Subjects known to be allergic to the study drug or its active ingredients or excipients, or subjects with prior severe hypersensitivity to other monoclonal antibody therapy in the past.\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 allogenic bone marrow transplantation or solid organ transplantation.\n* Subjects who have diseases requiring systemic therapy with corticosteroids (\\> 10 mg of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive medications within 14 days prior to the study drug administration. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy is allowed with a dose of ≤ 10 mg of prednisone or equivalent doses of other glucocorticoids.\n* Subjects who took moderate to strong CYP3A4 inhibitor\u002Finducer medications within 14 days prior to the first dose of study drug.\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* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (toxicity has not resolved means the severity of the toxicity events has not been graded as ≤ level 1 according to National Cancer Institute- Common Terminology Criteria for Adverse Events \\[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. 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, primary cervical carcinoma in situ, intraductal breast carcinoma in situ, and papillary thyroid carcinoma.\n* Subjects who have symptoms of active central nervous system metastases. However, subjects with stable brain parenchymal metastases can be enrolled.\n* Subjects who have active autoimmune disease that has received systemic treatment in the past 2 years (i.e., taking disease control medications, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered to be systemic treatments.\n* Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease. Has had a history of radiation pneumonitis.\n* Subjects who have serious psychiatric illness and are unable to cooperate in completing the clinical study.\n* Has an active infection requiring systemic therapy.\n* Has tuberculosis that is being treated.\n* Subjects who have known history of human immunodeficiency virus (HIV) or Anti- Treponema Pallidum test (anti-TP) positive.\n* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU\u002FmL or ≥ 10\\^3 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test).\n* Subjects who have history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL).\n* Subjects who have history of any myeloid malignancies including myelodysplastic syndrome (MDS), or subjects who have abnormal test results related to MDS or myeloproliferative neoplasm (MPN).\n* Women during pregnancy or lactation.",{"count":221,"type":20},204,[56,23],"In this study, participants with different types of advanced solid tumors who failed standard treatments will be treated with XNW5004 in combination with KEYTRUDA® (pembrolizumab) .",[225,226,227,228,229,230,231,232],"Carcinoma","Squamous Cell Carcinoma of Head and Neck","Urothelial Carcinoma","Prostate Cancer","Small-cell Lung Cancer","Non-small Cell Lung Cancer","Cervical Cancer","Other Solid Tumors",[155,234,235,236],"EZH2 inhibitor","KEYTRUDA® (pembrolizumab)","immune checkpoint inhibitors","2024-02-21",{"date":239,"type":37},"2024-02-23",{"date":241,"type":37},"2023-09-20",{"date":243,"type":20},"2028-08",{"name":43,"class":44},""]