Advanced Solid Tumors
Conditions
Interventions
Test group:SYS6002
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18, regardless of gender; 2. Patients with advanced solid tumors by histopathological diagnosis assays who failed or were intolerant to standard treatment or had no or refused standard treatment; 3. With at least one measurable lesion identified by CT or MRI according to RECIST v1.1; 4. 0-1 point based on Eastern Cooperative Oncology Group (ECOG) performance status; 5. Expected survival >= 3 months; 6. Main organs meet the following criteria within 7 days before treatment: Hematology: no component blood transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 and erythropoietin (EPO) within 2 weeks prior to the investigational drug administration Absolute neutrophil count (ANC) >=1.5*10^9/L; Platelet count (PLT) >=100*10^9/L; Hemoglobin (HGB) >=90 g/L or >=5.6 mmol/L; Renal Function: Serum creatinine clearance (CrCL) Participants at dose escalation, PK expansion and cohort expansion stage: >= 30 mL/min, calculated based on Cockcroft-Gault formula or 24-hour urine test;The urothelial carcinoma participants with severe renal insufficiency at the dose escalation and PK expansion stage: [15, 30) mL/min, calculated based on Cockcroft-Gault formula or 24-hour urine test? Liver function: Total bilirubin (TBIL) <= 1.5ULN, or <= 3ULN for patients with Gilbert syndrome Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<= 2.5ULN, or <= 5ULN in case of liver metastases; for urothelial carcinoma participants with severe renal insufficiency at the dose escalation and PK expansion stage, ALT and AST <= 1.5ULN Coagulation Function: Activated partial thromboplastin time (APTT) 1.5ULN International normalized ratio (INR) 1.5ULN 7. The serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to take adequate contraception from signing of ICF to 6 months after the last dose, during which women should be non-lactating and men should refrain from donating sperms; 8. The participant voluntarily participates in this clinical study, understands the study procedures and is able to sign the ICF.
Exclusion criteria
Exclusion criteria: 1. With active central nervous system (CNS) metastasis and/or leptomeningeal metastasis. The participants with active CNS metastasis include participants with symptomatic (previous or new onset) and asymptomatic (previous or new onset) CNS metastasis requiring treatment. If central nervous system metastasis is limited to the supratentorial ventricles and/or cerebellum (i.e., no metastasis to the midbrain, pons, medulla or spinal cord), local treatment is received, the neurological symptoms have become stable for at least 2 weeks before the first dose of the investigational drug and no hormonal therapy or prednisone (or equivalent) of 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate); 2) With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; 3) Grade III and above heart failure by New York Heart Association (NYHA) classification; in the tests and examinations during the screening period, left ventricular ejection fraction (LVEF) = 8%; 2) With active keratitis and corneal ulcer; 3) With >= Grade 2 neuropathy before the first dose of the investigational drug; 4) Severe infection within 4 weeks before the first use of the investigational drug, including but not limited to bacteremia and severe pneumonia requiring hospitalization; active infection of >= Grade 2 of CTCAE v5.0 requiring systemic antibiotics, antiviral or antifungal therapy within 2 weeks before the first dose of the investigational drug; 5) Active HBV or HCV infection HBV DNA >= 2000 IU/mL, HCV antibody positive and HCV RNA higher than the lower LOD of the analytical method); 6) Those with a history of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; 7) Any other malignant tumor within 5 years before the first dose of the investigational drug, except for cured skin basal cell carcinoma and cervical carcinoma in situ after surgery. 4. Prior therapy: (1) Have received other unmarketed clinical investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study; (2) The time interval between the latest anti-tumor treatment and the first dose of the investigational drug meets the following requirements: Have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical investigational drugs within 4 weeks before the first dose of the investigational drug; have received oral fluoropyrimidines, small molecule targeted drugs and traditional Chinese medicines with anti-t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: Occurrence and frequency of Adverse Event (AE), Serious Adverse Event (SAE) and Dose-limiting Toxicity (DLT);;MTD (if any) and RP2D.; | — |
Countries
China
Contacts
Public ContactYe Dingwei?Zhang Jian
Fudan University Shanghai Cancer Center
Outcome results
None listed