Product Description
FZ-AD005 was generated by a novel anti-DLL3 antibody FZ-A038 and a valine-alanine (Val-Ala) dipeptide linker to conjugate DXd. Moreover, Fc-silencing technology was introduced in FZ-AD005 to avoid off-target toxicity mediated by FcγRs and showed negligible Fc-mediated effector functions in vitro. In preclinical evaluation, FZ-AD005 exhibited DLL3-specific binding and demonstrated efficient internalization, bystander killing, and excellent in vivo antitumor activities in cell line-derived xenografts (CDX) and patient-derived xenograft (PDX) models. FZ-AD005 was stable in circulation with acceptable pharmacokinetic profiles in cynomolgus monkeys. FZ-AD005 was well tolerated in rats and monkeys. (Sourced from: https://aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-23-0701/746196/FZ-AD005-A-Novel-DLL3-Targeted-Antibody-drug)
Mechanisms of Action: DLL3 Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 1
Highest Development Phases
Phase 1: Large Cell Carcinoma|Neuroendocrine Carcinoma|Small Cell Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| F0041-101 | P1 |
Recruiting |
Neuroendocrine Carcinoma|Small Cell Lung Cancer|Large Cell Carcinoma |
2025-12-01 |