HER2-Positive Advanced Solid Tumors
Conditions
Interventions
experimental group:All patients will receive M802 once per week for continuous four weeks followed by a 4-week observation period.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Males or females, aged 18 to 60 years old; 2. Patients must have a diagnosis of histologically or cytologically confirmed advanced solid tumor with failure to standard treatment; 3. HER2 expression status report should be provided during the screening period with: fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH) test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and confirmed by amplification of FISH or CISH 4. Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the screening period. The anti-tumor treatment includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and radiotherapy (except for local radiation therapy for alleviating pain, at least 14 days after end of treatment); 5. Patients must have measurable lesions at baseline according to the RECIST v1.1; 6. Patients must have a ECOG PS Score of 0-1; 7. Patients must have an expected survival > 12 weeks; 8. Patients must have a left ventricular ejection fraction (LVEF) >=50%; 9. Patients must have adequate haematological and organ functions as indicated by the following laboratory values: 1) HaematologicalAbsolute Neutrophil Count(ANC) >=1.5*10^9/L; Blood Platelet Count (BPC)>=80*10^9/L; Hemoglobin>=9.0 g/dL (No blood transfusions within 14 days); 2) Hepatic: Bilirubin<=1.5 x ULN; AST and ALT <=2.5 x ULN (AST, ALT<=5 x ULN is allowed when there is liver metastasis); 3) Renal: Serum creatinine <=1.5x upper limit of normal (ULN); 10. Patients must understand and voluntarily agree to participate by signing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4 weeks before enrollment; 2. Patients with brain metastasis; 3. Patients who have uncontrollable active infections (Grade >=2 according to CTCAE v4.03); 4. Patients with severe respiratory disease who are not suitable for the study at the judgment of investigator; 5. Patients with severe immunosuppression (long-term use of immunosuppressant or glucocorticoid with daily dosage of dexamethasone >=10 mg); 6. Patients who have other malignant tumors in the past 5 years, except the complete cured cervical carcinoma in situ or basal cell or squamous cell carcinoma; 7. Patients with a history of serious cardiovascular disease, including receiving coronary artery bypass grafts or coronary stenting, occurrence of myocardial infarction, congestive heart failure within 6 months, or a history of unstable angina, uncontrolled severe hypertension or arrhythmia requiring medication; 8. Patients with a history of autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis); 9. Patients with severe hyperthyroidism or hypothyroidism; 10. Patients with metabolic diseases such as uncontrolled diabetes, severe gastrointestinal bleeding, severe diarrhea (Grade >=2 according to CTCAE v4.03), or severe gastrointestinal obstruction requiring intervention; 11. Patients with a history of immunodeficiency, including HIV positive; 12. Patients with Hepatitis b surface antigen test positive or hepatitis c antibody test positive; 13. Patients who have received inoculation of (attenuated) live virus vaccine within 4 weeks before screening; 14. Pregnant, lactating women, or females or males who have fertility plan within 12 months; 15. Patients with a previous history of definite neurological or psychiatric disorders, including epilepsy or dementia; 16. Patients who participated in clinical studies of other drugs within 4 weeks prior to the enrollment; 17. Patients with adverse reactions from previous treatment havent recovered to grade 1 according to CTCAE 4.03 (except for residual effect on hair loss); 18. Patients with poor compliance, or patients who are considered unqualified for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;PD;MTD;Immunogenicity;ORR;CRR;PFS; | — |
Countries
China
Contacts
Public ContactHu Xichun
Fudan University Shanghai Cancer Center
Outcome results
None listed