EGFR positive Advanced Solid tumors
Conditions
Interventions
medication administration team:SMET12 combined with toripalimab
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Full understood the study procedure and content, signed the informed consent voluntarilyfollow the study procedure; 2. Aged >=18 when signed inform consent; 3. Histopathological diagnosis confirmed subject with EGFR positive advanced solid tumors, who are failed after standard treatment, or cannot tolerate standard treatment or have no standard treatment or deny standard treatment.There are 2 treatment groups:group 1 recruits patients with EGFR positive melanoma; group 2 recruits patients with EGFR positive head and neck squamous cell carcinoma (HNSCC)urothelial carcinoma, gastric and esophageal squamous cell carcinoma, non-small cell lung cancer(NSCLC), RAS/BRAF wild-type Colorectal Cancer 4. At least 1 measurable lesion based on RECIST v1.1 criteria; 5. Appropriate time interval since last antineoplastic therapy and recovery or stabilization of associated toxicities from prior antineoplastic therapy; 6. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Participants have a history of severe and/or life-threatening toxicity related to prior anti-PD-1 or anti-PD-L1 therapy; 2. With complication of severe internal medical conditions; 3. Have any types of active autoimmune diseases or have a history of autoimmune disease, patients need systematic steroid therapy; 4. Have active infection that needs system treatment; 5. Known metastatic cancer of the central nervous system, or other central nervous system diseases or abnormalities, judged by the investigator as inappropriate for inclusion in this study; 6. Participants who are women of childbearing potential (WOCBP) or male, and female partners of male participants who are WOCBP can't follow instructions for method(s) of contraception for the duration of treatment with study treatment; 7. The investigator determined that patients for other reasons were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy;objective response rate, ORR;Disease control rate, DCR;Progression-free survival, PFS;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactYu Chen
Fujian Cancer Hospital
Outcome results
None listed