Relapsed/refractory advanced solid tumors
Conditions
Interventions
Experimental group:Oral administration of XNW5004 tablets 1200 mg
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range is 18 to 65 years old (including 18 and 65 years old), with no gender restrictions; 2. Patients with advanced solid tumors diagnosed by histology or cytology; And the previous standard treatment has failed, currently intolerant, unsuitable or without a standard treatment plan; 3. Subjects' laboratory data meet the following requirements: 1) hematopoietic function: a) absolute neutrophil count (ANC) >= 1.5 x 10^9/L (no G-CSF use within 1 week prior to routine blood tests during the screening period and no use of long-acting leukocyte boosters within two weeks); b) platelet count >= 100 x 10^9/L (no platelet transfusion, no use of TPO receptor agonists); c) hemoglobin >= 100 g/L (no transfusion of red blood cells or use of EPO within 1 week prior to routine blood tests during the screening period); 2) liver function: serum total bilirubin =60 mL/min based on the Cockcroft-Gault formula (Cockcroft-Gault formula, see Appendix 1 for details); 4) left ventricular ejection fraction (LVEF) >=50%; 5) coagulation assay: international normalized ratio (INR) <=1.5×ULN (Gilbert's syndrome), alanine aminotransferase (ALT) and glutamic oxalate aminotransferase (AST) <=2.5×ULN; 5) coagulation test assessment: international normalized ratio (INR) <= 1.5 x ULN or plasma prothrombin time (PT) <= 1.5 x ULN. if the patient is currently on anticoagulant therapy, INR <= 3 x ULN. Translated with DeepL.com (free version); 4. The ECOG score (see Appendix 2 for details) ranges from 0 to 1, and the expected lifespan is at least 12 weeks; 5.Before entering this study, women of childbearing age must have a negative serum pregnancy test and agree to complete contraception for at least 6 months from the start of the study until the last administration of the investigational drug; Female subjects with no possibility of reproduction should have natural amenorrhea for at least 12 months, and after undergoing female hormone testing and being judged by a specialist to have no fertility function, they can be included in the study; Or have undergone bilateral oophorectomy, hysterectomy, or tubal ligation at least 6 weeks before the screening period; Male participants must agree to take sufficient contraceptive measures from the start of the study to at least 6 months after the last administration of the investigational drug, and sperm donation is prohibited. 6. Prior to conducting the specialized procedures for this study, provide a signed and dated written informed consent, and be able to comply with clinical visit and study related procedures.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with EZH2 inhibitors, EZH1/2 inhibitors, or drugs with similar or related pathways to the investigational drug; 2. Subjects who are allergic to the investigational drug or its active ingredients or excipients; 3. Within 4 weeks before the first administration or within 5 half lives (whichever is longer), chemotherapy, immunotherapy, curative radiotherapy, major surgery, targeted therapy and other anti-tumor treatments have been used; Palliative radiotherapy is administered within 2 weeks prior to the first dose; 4. Participants who have participated in any other clinical trials within 28 days prior to the first administration of the study drug (the last administration of the study drug was within 28 days of the first administration of the study drug); 5. Subjects who have undergone major surgery within 4 weeks prior to the first administration or are planning to undergo major surgery during the study period (excluding procedures such as biopsy or lymph node biopsy); 6. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 7. Individuals with a history of abuse or drug use of psychotropic substances; 8. It is known that the subject has a bleeding tendency, such as von Willebrand's disease or hemophilia; 9. The subject is 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); 10. Past or current central nervous system metastases; 11. Past or current acute myeloid leukemia (AML); 12. Have any history of myeloid malignancies, including myelodysplastic syndrome (MDS), or have abnormal detection indicators related to MDS or myeloproliferative neoplasms (MPN); 13. Previously suffered from or accompanied by 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, mental illness, etc; 14. Active autoimmune diseases that require systemic treatment (i.e. the use of disease regulating drugs, corticosteroids, or immunosuppressants) within the past 2 years. Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments; 15. Impaired heart function or clinically severe heart disease, including any of the following: 1) acute myocardial infarction within 12 months prior to the first administration; 2) Unstable angina pectoris; 3) Congestive heart failure (New York Heart Association functional class III or IV, see Appendix 3 for details); 4) Unregulated severe arrhythmia and hypertension >= 150/100 mmHg; 5) QTc interval prolongation (defined as QTCF>450ms in males and>470ms in females) (Fredericia's formula, see Appendix 4 for details); 6) Previous history of other major cardiovascular diseases (such as valve replacement surgery, coronary artery bypass surgery, etc.); 16. Tumor invasion of important organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) poses a risk of bleeding or esophagotracheal fistula or esophageal pleural fistula; 17. Subjects with clinical symptoms and poorly cont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Xuewen Liu
The Third Xiangya Hospital Central South University
Outcome results
None listed