Drug intelligence / Profile preview

FDA018-ADC

Development stage
Phase 3
Lead developer
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

FDA018-ADC is an antibody-drug conjugate (ADC) targeting Trophoblast cell-surface antigen 2 (TROP2), developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical. It consists of a humanized anti-TROP2 monoclonal antibody conjugated to a topoisomerase I inhibitor payload (SN-38). TROP2 is highly expressed in various epithelial tumors, including triple-negative breast cancer (TNBC), gastric cancer, and lung cancer. Upon binding to TROP2 on the tumor cell surface, the ADC is internalized, and the payload is released to induce DNA damage and cell death. It is currently being evaluated in Phase 3 clinical trials for patients with locally advanced or metastatic TNBC who have failed prior taxane therapy.

02

Targets

TOP1 (DNA Topoisomerase I)TACSTD2 (Tumor-associated calcium signal transducer 2)

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