Advanced solid tumor
Conditions
Interventions
Experimental group:XNW5004
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Advanced/metastatic solid tumors: (1) Aged >=18 years; gender is not limited; (2) Patients with advanced/metastatic solid tumors confirmed by histology or cytology, ineffective to standard treatment, or intolerant of standard treatment, or without standard effective treatment; (3) In the dose expansion stage, there must be at least one measurable lesion as the basis for evaluation: for solid tumors, according to RECIST 1.1 criteria, there must be at least one measurable lesion (see Appendix 4 for details); (4) Agree to provide tumor tissue samples that meet the testing requirements (re-biopsy, paraffin block or 8-10 5µm pathological white slices, etc.); If the patient is unable to provide tumor tissue samples during the dose escalation stage, if other criteria for inclusion and exclusion are met, they can be enrolled after evaluation by the investigator; (5) Expected life expectancy of at least 12 weeks; (6) ECOG physical fitness score is 0-1; (7) The functional reserve of vital organs meets the following requirements: 1) Bone marrow function: in the absence of blood transfusion, G-CSF and drug correction within 7 days before the screening period, the absolute value of neutrophil count is >=1.5x10^9/L, hemoglobin is >=90 g/L, platelet count >=80x10^9/L; 2) Liver function: serum total bilirubin = 60 mL/min (Cockcroft-Gault formula, see Appendix 6 for details); 4) Left ventricular ejection fraction (LVEF) >= 50%; 5) International normalized ratio (INR) or plasma prothrombin time (PT) = 18 years; gender is not limited; (2) Pathologically confirmed, relapsed or refractory non-Hodgkin lymphoma (NHL). The definitions of relapse and refractory are as follows: 1) Relapse: After achieving remission, NHL is eligible for disease progression again. For B-NHL patients, two-line drug treatment regimens (the first-line containing CD20 monoclonal antibody), or inappropriate/intolerant (such as toxic and side effects) second-line systemic treatment regimens should be followed; 2) Refractory: After at least two regimens, and the total number of courses of treatment is not less than 4 cycles of standard systemic drug therapy, and partial remission has not been achieved; (3) There is at least one measurable lesion as the basis for evaluation: intranodal lesions require a lon
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria common to all indications: (1) Patients who have previously received drugs with similar or related pathways to the test drug (such as EZH 1/2 or EZH2 inhibitors, etc.); (2) Those who have received anti-tumor therapy in the past but the toxicity has not recovered (the toxicity has not recovered to =150/100mmHg; 4) QTc prolongation (defined as >450ms in males and >470ms in females) (Fredericias formula, see Appendix 7 for details); 5) History of other major cardiovascular diseases (such as valve replacement, coronary artery bypass grafting, etc.); (5) Systemic active serious infection; (6) HIV positive, syphilis (Anti-TB) positive; (7) HBsAg positive; or HBsAg negative, but HBcAb positive and the HBV-DNA copy number higher than the upper limit of the normal limit of the detection value; HCV antibody positive, and the HCV-RNA copy number higher than the normal upper limit of the detection value; (8) Patients who are known to be allergic to the study drug or its active ingredients and excipients; (9) Patients who have undergone major surgery within 4 weeks before the start of study treatment or are scheduled to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy); (10) Patients unable to swallow, or active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of previous gastrectomy or gastric banding that affects drug absorption. However, gastroesophageal reflux previously treated with proton pump inhibitors is permissible (if there is no possibility of drug interaction); (11) Patients taking known CYP3A4 inhibitors/inducers within 14 days before the first dose (see Appendix 7 for details); (12) A history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL); (13) Patients with any history of myeloid malignancies, including myelodysplastic syndrome (MDS), or abnormal test indicators related to MDS or myeloproliferative neoplasms (MPN); (14) Those who have a history of psychotropic substance abuse or drug abuse; (15) The Patients are known to suffer from diseases with bleeding tendency, such as von Willebrand's disease or hemophilia, or require long-term treatment with warfarin or other vitamin K antagonists (such as phenylprocoumarin); (16) Those who may not be able to complete this study for other reasons or should not be included in the researcher's opinion. 2. Advanced/metastatic solid tumors: (1) There are symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases or a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics;Pharmacodynamic (PD) characteristics; | — |
Countries
China
Contacts
Public ContactLi Linlin
Suzhou Sinovent Pharmaceutical Technology Co., Ltd.
Outcome results
None listed