A Phase 1 interventional study of FZ-AD005 in Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma), sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 162 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: FZ-AD005
Every 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
Time frame: 21 Days (first cycle)
Maximum Tolerable Dose (MTD)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Time frame: 21 Days (first cycle)
Adverse Events (AEs）
To check the numbers of AEs happened during the course of trial.
Time frame: Screening up to study completion, assessed up to 60 months
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
Time frame: Up to 60 months
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.
Time frame: Up to 60 months
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).
Time frame: Up to 60 months
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.
Time frame: Up to 60 months
Anti Drug Antibody (ADA)
To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample
Time frame: Up to 36 months
Time to peak (Tmax)
To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
Time frame: Up to 18 weeks
Terminal elimination half-life (t1/2)
To measure the time of Total Antibody, Free DXd and FZ-AD005 will take to eliminate half of it's concentration from participants.
Time frame: Up to 18 weeks
Maximum observed plasma concentration (Cmax)
To measure the maximum concentration participants obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.
Time frame: Up to 18 weeks
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity
To measure the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD005 in participants blood plasma
Time frame: Up to 18 weeks
Time to Cmax (Tmax)
To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
Time frame: Up to 18 weeks
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.