Advanced Solid Tumors
Conditions
Interventions
Test group:SYS6010+SYH2051
Test group:SYS6010+SYH2051+Bevacizumab
Control group:SYS6010
Sponsors
Sun Yat-sen University Cancer Center, Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Patients with pathologically confirmed advanced solid tumors who have no standard therapy available,or have failed standard therapy or are intolerant to it. 3. Must provide a tumor tissue sample for EGFR expression testing, with confirmed EGFR positive, or exist EGFR mutation. 4. At least one measurable lesion confirmed according to RECIST v 1.1 criteria. 5. ECOG performance status score of 0-1. 6. Expected survival of =3 months. 7. Major organ functions must meet relevant laboratory criteria for blood counts, renal function, liver function, and coagulation within 7 days prior to treatment. 8. Subjects agree to use effective contraception during the study and for 6 months after the last dose, with women being non-lactating and men refraining from sperm donation. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first administration of the study drug. 9. Voluntarily participate in the study, understand the study procedures, and be able to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with a TopI-containing ADC. 2. Has no adequate treatment washout period before enrollment. 3. Has other primary malignancies within 5 years prior to the first dose of the study drugs. 4. History of severe cardio-cerebrovascular disease. 5. Adverse events from prior anti-tumor treatments that have not resolved to = Grade 1 of CTCAE V5.0. 6. Patients with active central nervous system and/or leptomeningeal metastases. 7. Clinically significant pleural effusion, peritoneal effusion, or pericardial effusion requiring intervention. 8. Has a history of Interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids, has current ILD/non-infectious pneumonitis, or where suspected ILD/non-infectious pneumonitis cannot be ruled out by imaging at screening. 9. Patients with thyroid dysfunction requiring treatment, but that well-controlled was allowed. 10. Severe infections within 4 weeks prior to the first administration of the study drugs (e.g., bacteremia, severe pneumonia, active pulmonary tuberculosis, etc., requiring hospitalization). 11. Prior interruption of EGFR-targeted therapy due to skin toxicity, or skin diseases requiring oral or intravenous treatment currently. 12. Known allergy to any component of SYS6010 or SYH2051, or any humanized monoclonal antibody product. 13. Severe ophthalmic history (e.g., dry eye syndrome, keratitis, conjunctivitis, etc.). 14. Had a history of autoimmune disease (except tuberous sclerosis), immunodeficiency (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or organ transplantation. 15. Active HBV, HCV infection or syphilis infection. 16. Otherwise considered inappropriate for the study by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;Dose limited toxicities;Maximum Tolerated Dose;objective response rate; | — |
Countries
China
Contacts
Public ContactRuihua Xu/ Rongbo Lin
Sun Yat-sen University Cancer Center, Fujian Provincial Cancer Hospital
Outcome results
None listed