EGFR positive Advanced Solid tumors
Conditions
Interventions
Dose escalation phase 10 µg cohort:SMET12 for injection
Dose escalation phase 30 µg cohort:SMET12 for injection
Dose escalation phase 60 µg cohort:SMET12 for injection
Dose escalation phase 100 µg cohort:SMET12 for injection
Dose escalation phase 120 µg cohort:SMET12 for injection
Dose expansion phase:SMET12 for injection
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the study, voluntarily sign the informed consent form, and be willing and able to comply with the study procedures. 2.Age >=18 years. 3.Study population: Dose escalation phase: Patients with EGFR-positive advanced solid tumors who have failed standard therapy, have no available standard therapy, or are currently unsuitable for standard therapy. Dose expansion phase: Patients with EGFR-positive target indications who have failed standard therapy, have no available standard therapy, refuse standard therapy, or are currently unsuitable for standard therapy [tentatively including EGFR-positive head and neck tumors, EGFR-positive NSCLC, EGFR-positive gastrointestinal tumors (such as esophageal squamous cell carcinoma/cholangiocarcinoma), EGFR-positive endometrial carcinoma, and other tumor types]. 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. 5.Expected survival of more than 12 weeks. 6.Adequate bone marrow reserve and organ function as defined by the following criteria: Bone marrow reserve: Absolute neutrophil count (NE#) >= 1.5×10^9/L, platelet count (PLT) >= 90×10^9/L, and hemoglobin (HGB) > 9.0 g/dL (no blood transfusion or hematopoietic growth factor treatment within 14 days). Coagulation function: Activated partial thromboplastin time (APTT) prolongation =60 mL/min or serum creatinine = 50%. 7.At least one measurable lesion according to RECIST v1.1 criteria, and target lesions must not have received radiotherapy or must have shown clear radiographic progression after prior radiotherapy. 8.Fertile patients (both male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence methods) together with their partners during the study and for at least 3 months after the last dose; women of childbearing potential (as defined in Appendix 2) must have a negative serum or urine pregnancy test within 7 days before the first administration of the investigational drug.
Exclusion criteria
Exclusion criteria: 1.Known allergy or hypersensitivity to SMET12 for injection or any of its excipients, or a history of hypersensitivity; 2.Active or treatment-requiring bacterial, viral, or fungal infection within 2 weeks prior to the first administration of the investigational drug; 3.Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 4.Known central nervous system (CNS) metastases, or other CNS diseases or abnormalities deemed unsuitable for study participation by the investigator; 5.Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV); however, patients meeting the following conditions may be enrolled: a) Positive for HBsAg or hepatitis B core antibody (HBcAb) with HBV DNA below the lower limit of detection (500 IU/mL or 1000 copies/mL); b) Positive for HCV antibody (HCVAb) but negative for HCV RNA; 6.Toxicities from prior antitumor therapy not resolved to Grade =3 cardiovascular/cerebrovascular events within 6 months prior to first dosing; 15.Uncontrolled pleural effusion, pericardial effusion, or refractory ascites requiring drainage >= once per month; 16.Known history of substance abuse; 17.Pregnant or lactating women; 18.Any other systemic di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS(Overall Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(objective response rate);DCR(disease control rate);PFS(Progression Free Survival);incidence of adverse events;Laboratory aberrations;The severity of adverse events;PK(pharmacokinetics);ADA(Anti-drug antibody); | — |
Countries
China
Contacts
Public ContactHe Zhiyong
Fujian Cancer Hospital
Outcome results
None listed