Solid tumor
Conditions
Interventions
Breast Cancer Group:Trastuzumab rezetecan, 4.8 mg/kg, D1, Every 3 weeks was a treatment cycle
Other Tumors Group:Trastuzumab rezetecan, 4.8 mg/kg, D1
±Adebrelimab, 1200 mg,D1
Every 3 weeks was a treatment cycle
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign informed consent; 2. Age 18-75 years old, male or female; 3. Unresectable locally advanced or metastatic solid tumors confirmed histologically or cytologically 4. Refractory to at least one treatment or unacceptable/tolerated standard therapy; 5. IHC HER2 expression (IHC 1+/2+/3+) or HER2 mutation 6. Subject had at least one measurable lesion according to RECIST 1.1 criteria; 7. ECOG PS score: 0-1; 8. Expected survival time >= 3 months; 9. Laboratory test results within 14 days before enrollment meet the following requirements: (1) Routine blood test: (except hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no medication correction within 2 weeks before screening) : absolute neutrophil count >=1.5×10^9/L; Platelet count =75×10^9/L; Hemoglobin >=90 g/L; (2)Biochemical examination: serum albumin >=30g/L; Serum total bilirubin 50 ml/min; (3) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 10. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, HBV-DNA should be tested, and HBV-DNA should be <2000 IU/mL (<104 copy/mL if the research center has only copy/mL testing unit); Participants with HBV-DNA of at least 2000 IU per milliliter received antiviral therapy (only nucleoside agents such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets were allowed) for at least 1 week before enrollment and had a decrease in viral copy number by a factor of more than 10 (1 lg). For patients with HBV infection, antiviral therapy should be received throughout the study period. Hepatitis C virus (HCV) -RNA positive subjects must receive antiviral therapy according to treatment guidelines. 11. Women of childbearing age must have a negative (ß-HCG) pregnancy test before starting the first dose of medication. Women of reproductive age and men (who have sex with a woman of reproductive age) must agree to contraception during treatment and within 6 months of the last dose.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors in the past 5 years or at the same time; 2. The toxicity caused by previous antineoplastic therapy has not recovered to 10mg/ day of prednisone or other effective hormones); 7. Presence of active autoimmune disease or a history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (eligible if controlled only with hormone replacement therapy); Patients with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood without any intervention in adulthood were eligible. Patients with asthma who required medical intervention with a bronchodilator were excluded. 8. Congenital or acquired immune deficiency (e.g., HIV infection); 9. Patients had active infection, unexplained fever >=38.5? within 1 week before enrollment, or baseline white blood cell count >15×10^9/L; Therapeutic oral or intravenous antibiotics were administered within 2 weeks before enrollment (with the exception of prophylactic intravenous antibiotics administered for no more than 48 hours). 10. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) according to the New York Heart Association (NYHA) standard grade II or above cardiac dysfunction or color Doppler ultrasound electrocardiogram: LVEF (left ventricular ejection fraction) 450ms at rest (male); QTc>470ms (female); 11. Current treatment for interstitial pneumonia or interstitial lung disease, or other pulmonary diseases such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, or drug-associated pneumonia that may interfere with the diagnosis and management of immune-related pulmonary toxicity; 12. Subjects with current active tuberculosis; 13. Have received a live attenuated vaccine within 4 weeks before enrollment or are expected to require such vaccine during treatment or within 60 days after the last dose; 14. Known inherited or acquired bleeding (e.g. coagulopathy) or thrombophilia, as in hemophilia patients, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant or thrombolytic therapy (prophylactic use, such as low-dose aspirin, was allowed); 15. Arterial thromboembolism events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE3 or above deep vein thrombosis, pulmonary embolism, etc. 16. Severe, unhealed or dehiscence wounds and active ulceration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Respnse Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Safety;Overall Survival;Duration of Respnse;Progression-free survival;Tolerance to treatment; | — |
Countries
China
Contacts
Public ContactZhengxiang Han
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed