Patients with HER2-positive (IHC 2+ and FISH positive or IHC3+) relapsed or refractory solid tumors were treated with C406. The specific dose is adjusted by the researcher according to the patient's physical condition, tumor load, etc.
Conditions
Interventions
Experimental group:A predetermined dose of C406 was administered intravenously
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer to participate in clinical research; Understand and know about this study, and sign the informed consent; Willingness to follow all research procedures; Access to treatment and follow-up, including the subject's need to be treated at an enrollment center; 2.Male or female subjects aged 18-70 years; 3.Patients with histologically or cytologically proven advanced solid tumors who have failed standard therapy had TNM stages of stage IV (according to AJCC 8th Edition); 4.The presence of at least one measurable lesion according to RECIST 1.1 criteria, that is, a nonlymph node lesion =10 mm in diameter or a lymph node lesion =15 mm in diameter based on CT cross-sectional images or magnetic resonance imaging (MRI); 5.Her2-positive patients (defined as HER2 IHC 2+ with a positive FISH test, or HER2 with IHC3+); For patients with recurrence of HER2-targeted therapy, HER2 expression should be detected based on pathological findings after recurrence or re-biopsy and IHC. 6.The Eastern United States Oncology Consortium (ECOG PS) score was 0 to 1; 7. The expected survival is not less than 12 weeks; 8.Suitable organ and hematopoietic function, meeting the following requirements: - Hemoglobin (HGB) =90 g/L, no blood transfusion or growth factor support within two weeks; - White blood cell count (WBC) =2.5×109/L; Absolute neutrophil count (ANC) =1.5×109/L; - Platelet count (PLT) = 80×109/L; - Total bilirubin (TBIL) =3.0ng/dL or =1.5 ULN; - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×ULN; If the abnormal liver function is due to hepatocellular carcinoma or liver metastasis, AST and ALT =5×ULN; - Serum creatinine (Cr) =1.5×ULN; Creatinine clearance (CrCl)=50 mL/min; 9.Echocardiography showed left ventricular ejection fraction (LVEF) = 50%. 10.Serum troponin T < 0.03 ng/mL; 11. Prothrombin time (PT) : INR<1.5 longer, PT longer than the normal value <4 seconds;
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female subjects; 2. Subjects with active hepatitis B or active hepatitis C. If hepatitis B DNA or hepatitis C RNA were lower than the lower limit of detection after antiviral therapy, they could be included in this study; 3. Known HIV/AIDS infection; 4. Other clinically significant active infections; 5. Subjects with the following pre-existing or concomitant diseases: Subjects have a confirmed diagnosis of a severe autoimmune disease requiring systemic immunosuppressive (steroid) treatment for a prolonged period (more than 2 months), or have immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis); 6. Toxicity from previous treatment did not return to baseline (= grade 1) and was not stable. Patients with AE (such as hair loss, neuropathy, and specific laboratory abnormalities) who have been assessed as not likely to pose a safety risk are not included. 7. The subject has any mental illness, including dementia, altered mental status, that may affect informed consent and understanding of the relevant questionnaire; 8. A serious uncontrollable disease determined by the investigator that may affect the subjects treated in this study; 9. Other active malignancies within the previous 2 years. Participants were not included if basal or squamous skin cancer, superficial bladder cancer, or breast cancer in situ had been completely cured and did not require follow-up treatment. 10. Subjects are being treated with systemic steroids or steroid inhalants; 11. Patients who have received antitumor therapy (including monoclonal antibodies or cell therapy) within 4 weeks prior to initial administration. (Except for the antisepsis or bridging therapy given in this study); 12. Subjects allergic to immunotherapy or related drugs; 13. Patients who (1) have meningeal metastasis or central nervous system metastasis or (2) have a clear underlying central nervous system disease in the past 6 months and have significant remaining symptoms should be excluded; 14. In the 6 months prior to the first dosing, there were: (1) NYHA heart failure rating greater than grade 2 (2) subjects with hypertension that could not be controlled by standard treatment and required special treatment (3) patients with a history of myocarditis (4) patients with myocardial infarction, pulmonary embolism, cerebrovascular accident, or acute chest pain. Satisfy either will be excluded. 15. Those who have previously received an organ transplant or are preparing to receive one; 16. Patients with active bleeding; 17. Patients with uncontrolled pleural and abdominal effusion requiring clinical treatment or intervention; 18. Patients who had undergone major surgery or had not fully recovered from previous surgery within 8 weeks prior to study initiation; 19. Patients who received radiotherapy within 8 weeks prior to study initiation, excluding those who received palliative radiotherapy at peripheral bone metastases for more than 2 weeks, and who have recovered from all acute toxicity of radiotherapy; 20. Patients who received anthracycline-based chemotherapy within 4 weeks prior to study initiation; 21. Subjects determined by the investigator to be unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability in patients following infusion of C406; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy of C406 in solid tumors; | — |
Countries
China
Contacts
Public ContactMeili Sun
Jinan Central Hospital
Outcome results
None listed