HER2-expressing locally advanced or metastatic malignant solid tumor
Conditions
Interventions
Experimental group:Videsetuzumab for injection (RC48-ADC)
Sponsors
Department of Biotherapy, Tumor Center, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors (except breast cancer, gastric cancer, biliary tract cancer, urothelial carcinoma); 2. The specimen of the primary or metastatic lesion of the subject was confirmed by the Department of Pathology of our hospital as HER2 expression (HER2 expression is defined as IHC1+, 2+, or 3+); 3. Patients who have previously received at least one line of treatment failure. Failure of first-line therapy is defined as the patient's inability to tolerate drug toxicity after first-line standard chemotherapy or targeted therapy during treatment or within three months of the end of treatment (with imaging evidence of disease progression) or two standardized drug reductions, or disease progression or recurrence during neoadjuvant/adjuvant therapy or within six months after the end of treatment; 4. Male or female, age >= 18 years; 5. Eastern Cancer Collaboration Group (ECOG) score 0-1, expected survival >= 3 months; 6. According to THE RECIST 1.1 standard, there is at least one measurable lesion; 7. Sufficient internal organ function (subject to the normal value of the clinical trial center): (1) Left ventricular ejection fraction >= 50%; (2) Blood count: hemoglobin (HGB) >= 90 g/L, white blood cell count (WBC) >= 3.0x10^9/L, neutrophil count (ANC) >= 1.5x10^9/L, platelet count (PLT) >= 80x10^9/L; (3) Blood biochemistry: total bilirubin (TBIL) = 50 mL/min according to the Cockcroft-Gault formula; 8. Female subjects are required to agree to use at least one medically approved contraceptive measure (e.g., IUD, contraceptive pill, condom, etc.) during the study treatment period and within 6 months after the end of the study treatment period, and the serum pregnancy test must be negative within 7 days before the study enrollment, and must be non-lactation, unless the female subject has naturally menopause, has undergone artificial menopause or sterilization (such as hysterectomy, bilateral adnexal resection, tubal ligation, etc.). Male subjects should agree to use at least one medically approved contraceptive measure (e.g., condom, abstinence, etc.) during the study treatment period and within 6 months of the end of the study treatment period; 9. Fully understand the study, participate voluntarily, commit to follow the trial and follow-up procedures, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received chemotherapy, radiotherapy (palliative local radiotherapy for bone metastases is within 2 weeks before study administration), targeted therapy (elution period of small molecule targeted drugs is 2 weeks or 5 half-lifespans [whichever is longer]), immunotherapy, traditional Chinese medicine therapy (Chinese medicine with anti-tumor indications has been used within 1 week), etc.; 2. Have a history of other malignant tumors (except cured cervical carcinoma in situ or cutaneous basal cell carcinoma and other malignant tumors that have been cured for 5 years); 3. Those who have previously received treatment with other antibody-conjugated drugs (such as T-DM1 and SGN-35); 4. There is metastases of the central nervous system (CNS) and/or cancerous meningitis. Participants who have previously received brain metastases may consider participating in this study, provided that they are stable for at least 6 months, imaging tests within 4 weeks prior to dosing determine that no disease progression has occurred, that all neurologic symptoms have returned to baseline levels, that there is no evidence of new or enlarged brain metastases, and that radiation, surgery, or steroid therapy is discontinued at least 28 days prior to the first administration of treatment in the study. This exception does not include cancerous meningitis, which should be excluded regardless of whether its clinical condition is stable or not; 5. Serious and uncontrollable concomitant diseases, including concomitant uncontrolled infections, diabetes mellitus with active tuberculosis that cannot be controlled, cardiovascular disease (Grade III or IV heart failure as defined by the New York College of Cardiology' NYHA classification, heart block above degree II., myocardial infarction, unstable arrhythmias or unstable angina, cerebral infarction within 6 months, etc.), lung diseases (interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm), Deep vein thrombosis or pulmonary embolism, decompensated cirrhosis, etc. within 12 months; 6. Have an active autoimmune disease that requires systemic therapy within the past 2 years (e.g., using disease-modulating drugs, corticosteroids, or immunosuppressive drugs) that allows for associated replacement therapy (e.g., thyroxine, insulin, or phytochemical corticosteroid replacement therapy for adrenal or pituitary insufficiency); 7. The toxicity of previous anti-tumor therapy has not yet returned to grades 0 to 1 as defined in CCAE version 5.0, except for hair loss, pigmentation, anemia, weakness, and long-term toxicity caused by radiotherapy that cannot be restored; 8. Serological virology: positive human immunodeficiency virus (HIV) test result; HBsAg positive also detected hepatitis B virus (HBV) DNA copy number positive (copy number >= 2000 copies/ml); patients with positive HCV antibody test results can only be included in this study if the PCR test result of HCV RNA is negative; 9. Have undergone major surgery within 4 weeks before joining the group, and have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 10. Vaccination within 4 weeks prior to enlistment or planned anti-tumor vaccination during the study period; 11. A large amount of pleural fluid or ascites accompanied by clinical symptoms, which is judged by the researchers to be unsuitable for admission; 12. Any other situation in which the investigator de
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Duration of remission;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactLiu Jiyan
West China Hospital, Sichuan University
Outcome results
None listed