This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.
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;
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;
Sequential
FZ-AD004
DrugDose Escalation：Subjects will receive an intravenous infusion of FZ-AD004 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. Dose Expansion：Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1 of each cycles.
The dose limiting toxicity ( DLT)
To determine the dose limiting toxicities (DLTs) of FZ-AD004.
Maximum Tolerable Dose (MTD)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Adverse Events
To check the numbers of AEs happened during the course of trial.
Objective Response Rate (ORR) according to RECIST 1.1
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD004 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.
Progression free survival(PFS) according to RECIST 1.1
Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Duration of Response(DOR) according to RECIST 1.1
Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Overall Survival (OS) according to RECIST 1.1
Overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.
Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004
To check how much time Total Antibody, Free DXd and FZ-AD004 will take to eliminate half of it's concentration from participants.
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