Malignant tumors of bone and soft tissue
Conditions
Interventions
Zeprumetostat treatment group:Zemetostat tablets will be administered orally continuously at a fixed dose of 350mg according to the BID dosing protocol, and the dose will not be adjusted solely based
Sponsors
The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
Eligibility
Sex/Gender
All
Age
12 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before any trial-related procedures are performed. 2. At the time of obtaining informed consent, male or female aged >=12 years and =18 years and 3 months. 9. Archival tissue from within the past 3 years is available, or if not available, willingness to undergo a fresh biopsy for retrospective diagnosis and exploratory biomarker testing at the central pathology laboratory. 10. Adequate major organ function meeting the following requirements: (1) Absolute neutrophil count >=1.5×10^9/L, platelet count >=80×10^9/L, hemoglobin >=90 g/L (no blood transfusion within 7 days). (2) Total bilirubin =60 mL/min (Cockcroft-Gault formula). (4) Serum albumin >=30 g/L. (5) Thyroid-stimulating hormone (TSH) <=1×ULN (if abnormal, free T3 and free T4 levels should also be evaluated; if both are within normal limits, the patient may be enrolled). 11. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and agree to use adequate contraception during the study and for 8 weeks after the last dose; male patients must be surgically sterile or agree to use adequate contraception during the study and for 8 weeks after the last dose.
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to comply with the protocol due to psychological, family, social, or geographical reasons. 2. Currently participating in interventional clinical research treatment, or having received other investigational drug therapy within 4 weeks before the first dose. 3. Patients who have previously received therapy with EZH2 or EZH1/2 inhibitors. 4. Patients with implanted radioactive seeds. 5. Known immediate or delayed hypersensitivity reaction to drugs chemically related to the study drug or its excipients (including lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and Opadry® II), or having such a predisposition. 6. Symptomatic central nervous system metastases, unstable neurological function, or central nervous system disease requiring increasing doses of steroids for control. 7. Gastrointestinal diseases that may affect the absorption of the study drug. 8. Clinically significant cardiac symptoms or diseases that are not well controlled, such as: (1) heart failure of NYHA class 2 or above; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc>450 ms (male); QTc>470 ms (female). 9. Arterial/venous thrombotic events occurring within 6 months before enrollment, such as cerebrovascular accidents (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 10. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg). 11. Abnormal coagulation function (INR>2.0, PT>16 s), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted. 12. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.). 13. Failure to fully recover from toxicities and/or complications caused by any intervention before the start of treatment (i.e., 2000 IU/ml (or 10^4 copies/ml); or HCV RNA >10^3 copies/ml; or patients who are HBsAg positive and anti-HCV antibody positive. 18. Received live vaccine within 30 days before the first dose. 19. Presence of any medical history, disease, treatment, or laboratory abnormality that may interfere with the trial results or prevent the subject from full participation in the study, or the investigator considers that participation is not in the subject's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR );Progression-Free Survival (PFS);Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease Control Rate (DCR) ;Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactXiao Jianru
Shanghai Changzheng Hospital
Outcome results
None listed