HER2 positive solid tumors (breast cancer or gastric cancer)
Conditions
Interventions
Single arm:Recombinant Humanized Anti-HER2 Monoclonal Antibody-Maytansine Conjugate for Injection
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 7 Years
Inclusion criteria
Inclusion criteria: Only subjects meeting all the following criteria can be enrolled: 1. Aged 18-70 years; 2. Patients with advanced solid tumors refractory to standard treatment or of intolerable or no standard treatment. 3. Patients with breast cancer or gastric cancer (including gastroesophageal junction adenocarcinoma) histopathologically or cytologically diagnosed and tested HER2-positive (IHC 3+ and/or ISH+); 4. At least one measurable lesion according to RECIST version 1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Absence of severe hematopoietic abnormalities, and basically normal heart, lung, liver and kidney functions; 7. Expected survival >=3 months; 8. Laboratory tests: Hematologic System Absolute neutrophil count (NEU) >=1.5 x10^9/L; Platelet count (PLT) >=100x10^9/L; Hemoglobin (HB) >=90 g/L; Liver; Total bilirubin (TBIL) <=1.5 ULN; Aspartate Transaminase (AST) <=2.5 ULN; Alanine Transaminase (ALT) <=2.5 ULN; Alkaline Phosphatase (ALP) <=2.5 ULN; Kidney; Creatinine (Cr) <=1.5 ULN; Blood urea nitrogen (BUN) <=1.5 ULN; Coagulation Function; International Normalized Ratio (INR) <=1.5 ULN; Activated Partial Thromboplastin Time (APTT) <=1.5 ULN; Troponin; Troponin I (TnI) < 0.2 ng/mL; 9. Left ventricular ejection fraction (LVEF) by ultrasound examinations higher than the lower limit of normal range defined by the study site; 10. The cumulative dose of anthracyclines should meet the following: the cumulative dose must not exceed the equivalent dose of 360 mg/m2 doxorubicin; 11. At least 4 weeks after previous treatment of solid tumors and the patient has recovered from any prior treatment-related adverse reactions; 12. Female patients of childbearing age must be tested negative by serum pregnancy test 7 days before the first study dose; 13. Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have active hepatitis B virus or hepatitis C; 2. Patients who are positive for the human immunodeficiency virus; 3. Patients with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation; 4. Patients with clinically significant active infection as determined by the investigator; 5. Other concurrent, severe or uncontrollable systemic diseases (such as clinically significant metabolic disorders, poor wound healing, ulcers, etc.); 6. Moderate or severe dyspnea at rest caused by advanced malignant tumors or complications or serious primary lung diseases, or currently requiring continuous oxygen therapy, or currently having interstitial lung disease or pneumonia; 7. Cardiac insufficiency within the past 6 months before enrollment based on the following definitions: Grade = 3 symptomatic congestive heart failure (CHF) according to CTCAE v4.03, or a history of Grade = 2 symptomatic congestive heart failure, transmural myocardial infarction, unstable angina according to New York Heart Association (NYHA) Functional Classification, or severe arrhythmia without proper medicinal control, severe heart block, uncontrolled hypertension, or clinically significant cardiovascular disease; 8. Patients with central nervous system or brain metastasis symptoms, or who have received treatment for central nervous system or brain metastasis within 3 month before the first dose; 9. Grade >=2 peripheral neuropathy; 10. Previous participation in other clinical trials within 4 weeks before enrollment; 11. Patients who have undergone major surgery within 4 weeks before enrollment and yet completely recovered; 12. Patients who have undergone targeted therapy directly against HER2 within 4 weeks before enrollment; 13. Signs of clinically significant bleeding within 4 days before enrollment or on long-term anticoagulant, anti-platelet and other products that cause bleeding tendencies; 14. Previous use of strong CYP3A4 inhibitors that have not been completely cleared via circulation (less than 3 elimination half-lives) before the first study dose, or requiring concomitant use of strong CYP3A4 inhibitors during the study; 15. Known or suspected allergy to components in the investigational drug; 16. Pregnant or lactating women; 17. Alcoholic, drug addict or drug abuser; 18. Patients who are deemed unsuitable for participation in this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Immunogenicity;Security; | — |
Countries
China
Contacts
Public ContactShuseng Wang
Sun Yat-sen University Cancer Center
Outcome results
None listed