Drug intelligence / Profile preview

QLC5513

Development stage
Phase 2
Lead developer
Qilu Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

QLC5513 is a Trophoblast cell-surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC) being developed for the treatment of solid tumors, specifically triple-negative breast cancer (TNBC). It comprises a humanized monoclonal antibody targeting Trop2, conjugated to the cytotoxic payload SN38 (an active metabolite of irinotecan and a topoisomerase I inhibitor) via a proprietary stable linker. By binding to Trop2, which is frequently overexpressed in various epithelial cancers, QLC5513 facilitates the intracellular delivery of SN38, leading to DNA damage and apoptosis in malignant cells. It is currently being evaluated in Phase 2 clinical trials as a monotherapy and in combination with the dual PD-1/CTLA-4 checkpoint inhibitor QL1706 (epalolimab tovolimab).

02

Targets

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

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