A Study of FZ-AD004 in Patients With Advanced Solid Tumors

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.

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.
• Have measurable lesions defined in RECIST v. 1.1;
• Expected survival ≥ 12 weeks;
• 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

• Have had other malignant tumors in the past 5 years;
• Have CNS (central nervous system) metastasis with clinical symptoms;
• 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;
• Have history of psychotropic drug abuse, alcohol or drug abuse；
• Women who are pregnant or lactating；
• Other circumstances that is deemed not appropriate for the study.