A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.
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 ;
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；
Single group
FZ-AD005
DrugEvery 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
The dose limiting toxicity ( DLT)
To determine the dose limiting toxicities (DLTs) of FZ-AD005
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 (AEs）
To check the numbers of AEs happened during the course of trial.
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RECIST 1.1
Progression free survival(PFS)
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)
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)
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.
Anti Drug Antibody (ADA)
To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample
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