Advanced Solid Tumors
Conditions
Interventions
Dose escalation group:DX1002 table, PO, QD
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria are to be enrolled in this study: 1)Age 18 to 75 years old, no gender limitation; 2) With histologically or cytologically confirmed metastatic or locally advanced solid tumor(s) that is refractory to standard treatments, or for which a standard therapy is not available or is no longer effective; There is no limit on the number of treatment plans before enrollment; 3) With at least one measurable or evaluable target lesion as measured by MRI or CT according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria; 4)Life expectancy = 3 months; 5)Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6)Major organ functions should meet the following standards before treatment: a)Without growth factor support therapy and an absolute neutrophil count (ANC)of 1.5×10^9/L; b)Without blooding and growth factor support therapy, Hemoglobin(HB)=90g/L; c)Platelet (PLT) count=100×10^9/L; d)Serum creatinine(Scr) =1.5×upper limit of normal (ULN)or creatinine clearance(CCr)=60mL/min(if Scr>1.5×ULN); e) Total bilirubin (TBil ) =1.5×ULN; f) Aspartate aminotransferase (AST) levels and Alanine aminotransferase (ALT) levels= 5×ULN if liver metastases are present, AST and ALT = 2.5 ×ULN without liver metastases g)Alkaline phosphatase=2.5×ULN without liver metastases, Alkaline phosphatase=5×ULN if documented liver metastases h) Electrolyte: serum potassium =3.0 mmol/L; serum calcium=2.0 mmol/L; i) Fasting serum triglyceride=5.7mmol/L; j) Prothrombin time(PT)=1.2×ULN k) Activated partial thromboplastin time(APTT)=1.2×ULN 7) Subjects must be able to swallow whole tablets; 8) Subjects must agree to use effective contraception during the period of the trial; 9) Subjects or guardians of subjects voluntarily agree to participate in this study and sign written informed consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study 1) Subjects who have had chemotherapy , radiotherapy ,and monoclonal antibody therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of investigational product; Subjects who have had short half-life targeted therapy within 5 half-lives preceding the first dose of investigational product. 2) Subjects who are currently participating or have participated in other drug or medical device clinical studies within 4 weeks prior to the first dose of investigational product. 3) Subjects with treatment-related toxicity of anticancer therapy, and the severity of AE is more than grade 2 (nci-ctcae V4.03) (excluding hair loss and pigmentation) 4)Requirement of any drugs known to prolong the QTc interval 5)Women who are pregnant or lactating, Male and female subjects who are either unwilling or unable to use effective contraception within the prescribed time period (from 2 weeks before taking the study drug to 30 days after taking the last study drug); 6)History of the following cardiovascular diseases within 6 months prior to screening,: a) Myocardial infarction b) Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)); c) Acute coronary syndrome (myocardial infarction (MI), unstable angina); d) Major vascular diseases (such as aortic aneurysms, aortic dissections, internal carotid stenosis); e) Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA) ; f) PR, QT, QRS interval abnormalities: 12-lead ECG QTc> 450 ms (male) or> 470 ms (female), PR> 240 ms, QRS> 120 ms; 7) Subjects with pathological bradycardia (less than 60 beats / min for non-athletes), and cardiac block (except for subjects with first-degree block with extended PR interval) 8) Patients with cerebrovascular accident (including transient ischemic attack (TIA)), pulmonary embolism, or untreated deep vein thrombosis (DVT) within 6 months before screening; 9) Patients with uncontrollable persistent hypertension after medication, with systolic blood pressure (SBP)> 140 mm Hg or diastolic blood pressure (DBP)> 90 mm Hg (if the BP result is abnormal, measuring BP again, and time interval between the two measurements should be at least 30 minutes) 10) Patients who are allergic to drugs or excipients similar to the chemical structure of the study drug, or patients with allergies; 11) Patients who have substance abuse diseases that the investigator believes may increase the risk associated with participation in the drug study, active infections (including but not limited to active HIV, hepatitis B virus, and hepatitis C virus infections), other acute or chronic physical or mental illnesses or laboratory abnormal values; 12) Patients with diagnosed active central nervous system metastases and/or cancerous meningitis; excluding patients with central nervous system metastases, who have been treated and have reached clinical stability for 3 months before starting the study (defined as: (1) no evidence of new lesions or progression; (2) patients who do not require steroid therapy or use a stable dose of steroid therapy); 13) A clinically significant amount of ascites or symptomatic pleural effusion (except for patients who have achieved clinical stability after treatment); 14) Patients with dysphagia, absorption disorders or other chronic gastrointestinal diseases, or diseases that may affect compliance and /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Maximum tolerated dose (MTD);Dose-limiting toxicity,DLT;Pharmacokinetics,PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;Time to progression,TTP; | — |
Countries
China
Contacts
Public ContactRuihua Xu
Sun Yat-Sen University Cancer Center
Outcome results
None listed