Solid Tumor
Conditions
Interventions
Experimental Group:Trastuzumab (SHR-A1811) from Ruikang: 4.8 mg/kg, with 21 days as one cycle
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form; 2. Age >=18 years old; 3. Confirmed by histological examination and/or cytological examination and evaluated by imaging or ultrasound as the corresponding advanced tumor, and confirmed by pathological examination as HER2 positive, that is, the immunohistochemical detection of HER2>=1+; 4. Only Cohort 1: Histologically confirmed extra-mammary Paget disease, locally advanced or metastatic disease that cannot be surgically resected; Only Cohort 2: Histologically confirmed locally advanced or metastatic rare solid tumors with failed standard treatment or no alternative standard treatment, such as sarcoma, urachal carcinoma, etc. Only cohort 3: Patients with histologically confirmed locally advanced or metastatic urothelial carcinoma who progressed after first-line treatment with PD-1/PD-L1 inhibitors + vetinumab/vedotinumab; 5.ECOG score: 0-2; 6. At least one measurable lesion (according to the RECIST standard, the long diameter of non-lymph node lesions on CT scan is >=10 mm, and the short diameter of lymph node lesions on CT scan is >=15 mm). 7. Blood routine: Absolute Neutrophil Count (ANC) 1.5×10^9/L, Platelet (Platelet, PLT) >=70×10^9/L, Hemoglobin (Hemoglobin, HGB) >=80g/L; 8. Liver function: Serum Total Bilirubin (TBIL) =28 g/L 9. Renal function: Serum Creatinine (Cr) =50 mL/mi (applying the standard Cockcroft-Gault formula) : 10. Coagulation function: International Normalized Ratio (INR) =3 months; 12. A medically approved contraceptive measure must be used during the study treatment period and for at least 120 days after the study ends. During this period, sperm donation to others or cryopreservation for fertilization and reproduction is not allowed. Be able to comply with the research visit schedule and other agreement requirements.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions cannot be enrolled in this study: Subjects with any severe and/or uncontrollable diseases. Including: 1) Poor blood pressure control (systolic blood pressure >=150 MMHG or diastolic blood pressure >=100 MMHG); Poor diabetes control (fasting blood glucose [FBG] > 10mmol/L); 2) Suffering from grade >=2 myocardial ischemia or myocardial infarction, arrhythmia (QTc>=470ms), and grade >=2 congestive heart failure (New York Heart Association [NYHA] classification); 3) Active or uncontrolled severe infections (CTCAE grade 2 infections) that require systemic antibacterial, antifungal or antiviral treatment, including pulmonary tuberculosis infections, etc. 4) Those with a history of active tuberculosis; 5) If it cannot be controlled, repeated drainage is still required, resulting in ascites, pericardial effusion, and pleural effusion. 2. Active hepatitis (transaminase does not meet the inclusion criteria. For hepatitis B, reference: HBV DNA>=2000 IU/ml or >=104 copies /ml; for hepatitis C, reference: HCV RNA>=2000 IU/ml or >=104 copies /ml; after nucleotide-based antiviral treatment, if the transaminase is lower than the above criteria, it can be enrolled). Chronic hepatitis B virus carriers, with HBV DNA < 104 IU/ml, must receive antiviral treatment simultaneously during the trial period to be enrolled. 3. Have a history of immune deficiency, including being HIV positive or suffering from other acquired or congenital immune deficiency diseases; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Known presence, meningeal metastasis, spinal cord metastasis or compression; 6. Esophageal and gastric fundus varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea within 6 months prior to the first administration; 7. There are unhealed or poorly healed wounds and active ulcers; 8. The toxicity of previous anti-tumor treatment was not relieved, defined as the toxicity not being restored to grade 0 or grade 1 of NCI CTCAE version 5.0; 9. Those who received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before the start of the study treatment; Or there are long-term unhealed wounds or fractures; 10. Those who have experienced severe hypersensitivity reactions after using monoclonal antibodies; Those who are known to be allergic to the active ingredients or excipients of the drug in this study; 11. Within 4 weeks prior to the start of the study, the applicant was currently participating in or had participated in other clinical researchers; 12. A live vaccine was administered within 30 days before the first administration, or a live vaccine is planned to be administered during the study period; 13. Those with a history of severe allergies; 14. There is a risk of bleeding, or coagulation dysfunction, or currently undergoing thrombolytic therapy; 15. Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders; 16. Subjects who, based on the researcher's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS);Overall Survival(OS); | — |
Countries
China
Contacts
Public ContactSheng Zhang
Fudan University Shanghai Cancer Center
Outcome results
None listed