Advanced breast cancer
Conditions
Interventions
Treatment group:Received treatment with KMHH-03 for injection,Administered by intravenous infusion
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects should all meet the following criteria to enter this trial: 1. Age >= 18 years old and = 1.5×10^9/L, platelet >= 100×10^9/L, white blood cell count >= 3×10^9/L, hemoglobin >= 90 g/L; (2) Renal function: serum creatinine = 50 mL/min (using the Cockcroft-Gault formula creatinine clearance rate); (3) Liver function: AST and ALT = 3 months; 7. No fertility plan within 2 weeks before screening and within 3 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial; 8. Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects who meet any of the following criteria will not be allowed to enter this trial: 1. Those who have a history of allergic reaction or intolerance to peptide drugs in the past, or are allergic to other components of the test drug injection; 2. Subjects with active brain metastases or meningeal metastases that have not been effectively controlled: those who need to use any radiological, surgical or drug treatment (including steroids, anticonvulsant drugs, etc.) to control metastatic symptoms within 1 month before screening cannot be enrolled, and those with a limited number of brain metastases in a stable state can be enrolled; 3. Those who have suffered from autoimmune diseases in the past and need to use glucocorticoids or immunosuppressive drugs; 4. Uncontrolled comorbidities or cancerous pain; 5. Uncontrollable hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg) after drug treatment; 6. Those with a history of severe heart disease in the past, such as: history of acute myocardial infarction or coronary angioplasty or stent implantation within 12 months, unstable angina, myocarditis, chronic heart failure of >= grade III (standard of the New York Heart Association), or QT interval prolongation (>470 ms for women; >450 ms for men) or a history of severe arrhythmia; 7. Those with a history of severe kidney disease in the past, such as chronic nephritis, renal insufficiency, etc.; 8. Current presence of uncontrolled active infection; 9. Patients with active hepatitis B (HBsAg positive, and peripheral blood HBV DNA titer >=1×10^3 IU/mL), and/or hepatitis C, and/or clinically diagnosed with chronic hepatitis, or patients with positive human immunodeficiency virus (HIV) antibody screening results; 10. Other malignant tumors within 5 years prior to screening, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell carcinoma that has been previously treated for the purpose of radical cure; 11. Those who have received the new crown vaccine within 28 days before screening or other vaccines within 3 months before screening or plan to be vaccinated during the trial; 12. Subjects who have received systemic steroid therapy within 14 days prior to the first dose and are judged by the investigator to require long-term systemic steroid therapy during the treatment period (except for inhaled or topical use, physiological replacement dose); 13. Participation in any other interventional clinical trial within 28 days prior to the first dose; 14. Received blood transfusion and/or colony-stimulating factor-related therapy within 28 days prior to the first dose; 15. Those who have received major surgical and/or anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted and immunotherapy, etc.) within 28 days prior to the first dose, and have not recovered from the toxicity of these interventions (the toxicity has not recovered to Grade <=1 according to NCI-CTC AE version 5.0), except for alopecia; 16. Women who are trying to conceive, pregnant, or breastfeeding; 17. Any other situation that the investigator considers to be inappropriate to enter this trial because it may increase the risk of the subject or interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of AEs during the trial, as well as DLT and MTD after drug administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of ADA and Nab in the trial;The primary efficacy index: the quantity and percentage of CR, PR, SD patients and PFS.; | — |
Countries
China
Contacts
Public ContactTong Zhongsheng
Tianjin Cancer Hospital
Outcome results
None listed