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225Ac-DOTA-M5A

Development stage: Phase 1
Lead developer: City of Hope Medical Center
Modality: Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Intravenous

Overview

225Ac-DOTA-M5A is an experimental targeted alpha-particle therapy (TAT) developed by City of Hope for the treatment of carcinoembryonic antigen (CEA)-positive malignancies. The agent consists of the humanized monoclonal antibody M5A, which specifically targets the CEACAM5 (CEA) cell surface glycoprotein, conjugated to the alpha-emitting radioisotope actinium-225 (225Ac) via the bifunctional chelator DOTA. CEA is highly expressed in several solid tumors, including colorectal, pancreatic, and lung cancers, while showing limited expression in normal adult tissues. Upon binding to CEA on the tumor cell surface, 225Ac-DOTA-M5A delivers high-energy alpha particles that induce complex double-strand DNA breaks within a short range (50-100 μm), leading to potent cytotoxic effects with minimal collateral damage to adjacent healthy cells. It is currently being evaluated in Phase 1 clinical trials for patients with advanced CEA-positive cancers.

Other names: 225Ac-labeled humanized anti-CEA M5A antibody

Targets

CEACAM5 (Carcinoembryonic antigen related cell adhesion molecule 5)

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