EGFR positive advanced solid tumor
Conditions
Interventions
Cohort A:urothelium carcinoma:SMET12 injection and toripalimab combine paclitaxel
Cohort B:melanoma:SMET12 injection and toripalimab combine paclitaxel
Cohort C:other solid tumors:SMET12 injection and toripalimab combine chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures. 2. Age = 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry = [+]) Metastatic solid tumor ,including: (1) Cohort A: urothelium carcinoma subjects; (2) Cohort B: melanoma subjects; (3)Cohort C:other solid tumor subjects; 4. Progress after at least one systemic therapy, including chemotherapy immunotherapy, or targeted therapy (participants who have completed neoadjuvant or adjuvant therapy within <6 months and experienced disease progression are eligible). 5. At least one measurable lesion via RECIST v1.1 criteria 6. Eastern Cooperative Oncology Group (ECOG) performance status =2. 7. Expected survival = 3 months. 8. Adequate organ function .
Exclusion criteria
Exclusion criteria: 1. Prior interruption of treatment due to severe and/or life-threatening adverse events related to anti-PD-1 or anti-PD-L1 antibody. 2. History of Double Primary Malignancies within the past 5 years. 3. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid therapy. 4. Active systemic infection requiring systemic treatment. 5. Known central nervous system metastases, or other central nervous system diseases or abnormalities, deemed unsuitable for inclusion in this study by the investigator. 6. Fertile individuals unable to maintain effective contraception during the trial. 7. Patients who are considered unsuitable for participating in this clinical trial due to other reasons by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events;rate of adverse events;ORR(objective response rate);Laboratory aberrations;DCR(disease control rate);PFS(Progression Free Survival);DOR( Duration of Response); | — |
Countries
china
Contacts
Public ContactChen Yu
Fujian Cancer Hospital
Outcome results
None listed