A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Inclusion criteria

• Patients able to give written informed consent;
• Age ≥ 18 and ≤ 75 years old, male or female;
• Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
• Willingness to provide tumor tissue for testing ;
• Have measurable lesions defined in RECIST v. 1.1;
• Expected survival ≥ 3 months;
• Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
• Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion criteria

• Patients who have had previous treatment with any anti-DLL3 antibody；
• Have had other malignant tumors in the past 5 years;
• Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
• Have active CNS (central nervous system) metastasis；
• Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
• Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
• Patients have psychiatric history;
• Female patients who are breastfeeding or pregnant;
• Other reasons that researchers believe are inappropriate to participate in this study.