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DM001

Development stage
Phase 1
Lead developer
Doma Pharmaceutical Technology
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

DM001 is a novel, first-in-class bispecific antibody-drug conjugate (ADC) designed to target both epidermal growth factor receptor (EGFR) and trophoblast cell surface antigen 2 (TROP2), which are co-expressed at high levels in various solid tumors. The ADC consists of a bispecific monoclonal antibody that binds EGFR and TROP2, linked via an enzyme-cleavable linker to a potent topoisomerase I inhibitor cytotoxin payload. This design enables direct tumor cell killing as well as bystander effects, with the dual targeting promoting synergistic endocytosis and efficient delivery of the cytotoxic payload. Preclinical studies have demonstrated strong anti-tumor activity across multiple solid tumor models—including breast cancer, non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, and colorectal cancer—with favorable safety profiles. As of mid-2025, DM001 is in Phase 1 clinical trials for advanced solid tumors[3][4][5][6][7].

Other names
anti-TROP2/EGFR bispecific antibody-drug conjugate DM001
02

Targets

EGFR (Epidermal growth factor receptor)TACSTD2 (Tumor-associated calcium signal transducer 2)TOP1 (DNA Topoisomerase I)

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