urothelial carcinoma
Conditions
Interventions
A group:HuA21+SHR-A1811
B group:SHR-A1811 monotherapy, 4.8mg/kg, q3w
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research and sign the informed consent form (ICF); 2. Age >= 18 years, any gender; 3. Histologically or cytologically confirmed unresectable/metastatic advanced urothelial carcinoma, with HER-2 immunohistochemistry expression of 2+ or higher; 4. In the advanced or metastatic stage, have experienced failure or intolerance to first-line standard treatment. There should be imaging evidence of tumor progression during or after the most recent treatment confirmed by the investigator, or evidence of drug intolerance during treatment; 5. According to RECIST V 1.1 criteria, have at least one measurable lesion; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 7. Expected survival of >=12 weeks at screening; 8. Patients have adequate organ and bone marrow function and meet the following laboratory test criteria (based on the normal values of the clinical trial center): 9. Blood routine: (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelets (PLT) >= 75 × 10^9/L; (3) Hemoglobin (Hb) >= 80 g/L; 10. Liver function: Serum total bilirubin (TBIL) = 50 mL/min (calculated using the Cockcroft-Gault formula); 12. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN (without anticoagulant use), or subjects receiving anticoagulant therapy must be within the treatment target range and on a stable dose; activated partial thromboplastin time (APTT) <= 1.5 × ULN (without anticoagulant use), or subjects receiving anticoagulant therapy must be within the treatment target range and on a stable dose; 13. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose and must not be pregnant or lactating. Male or female patients of reproductive potential must agree to use at least one medically accepted contraceptive method during the study and for 6 months after the last study drug administration, such as dual barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. Female subjects should avoid donating eggs or breastfeeding during the study and for 6 months after the last study drug administration. Male subjects should avoid donating sperm during the study and for 6 months after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. A history of immunodeficiency, including positive HIV test results, or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 2. Having received treatment with live attenuated vaccines within 28 days before enrollment; 3. Having severe allergic reactions to the study drug, drugs of the same class, or their formulation excipients, or being of allergic constitution; 4. Having a history of substance abuse, mental illness or abnormalities, or any other medical conditions that the researcher believes may increase the safety risks for the subject or interfere with the subject's participation in the clinical study or the evaluation of the clinical study. 5. Having active brain metastases requiring dehydration and hormone therapy and/or carcinomatous meningitis; 6. A history of diseases such as acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, poorly controlled arrhythmia, etc., within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) classification of grade 2 or higher (including grade 2); left ventricular ejection fraction (LVEF) lower than 50%; 7. Currently participating in other clinical studies of unmarketed drugs, or having participated in other clinical studies of unmarketed drugs and received administration of the trial drug within 4 weeks before enrollment in this study; having undergone major surgery within 4 weeks before enrollment in this study or expecting to undergo major surgery during the study treatment period; 8. Toxicity from previous anti-tumor treatment has not recovered, defined as toxicity (except alopecia) not having recovered to = grade 1 (NCI-CTCAE v5.0) or baseline level. For subjects with chronic grade 2 toxicity (such as grade 2 neuropathy), they may be eligible to participate in this study at the researcher's discretion; 9. Having suffered from other malignant tumors within 5 years before enrollment (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, carcinoma in situ of the breast, carcinoma in situ of the lung, and microinvasive lung cancer); 10. According to the researcher's judgment, uncontrolled infections requiring intravenous antibiotics, antiviral drugs or antifungal drugs; uncontrolled and/or poorly controlled systemic diseases, including diabetes mellitus poorly controlled by drug therapy, autoimmune diseases, symptomatic pleural effusion, peritoneal effusion or pericardial effusion that require drainage or diuretic therapy/ cannot be controlled after appropriate intervention, etc; 11. Patients who are not suitable for participating in this study for other reasons, as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Disease control rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactDu Yingying
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed