Drug intelligence / Profile preview

Lu-177-RTX2358

Development stage: Unknown
Lead developer: Ratio Therapeutics
Modality: Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics
Administration: Intravenous

Overview

Lu-177-RTX2358 is an investigational radiopharmaceutical therapy (RPT) designed to target fibroblast activation protein-alpha (FAP), a cell-surface glycoprotein highly expressed by cancer-associated fibroblasts (CAFs) in the stroma of most epithelial tumors. Developed by RayzeBio (a Bristol Myers Squibb company), the drug consists of a high-affinity FAP-targeting ligand (RTX2358) conjugated to the therapeutic beta-emitting radioisotope lutetium-177. Upon administration, the agent selectively binds to FAP-expressing cells within the tumor microenvironment, delivering localized ionizing radiation that induces DNA damage and cell death. Early clinical data published in 2026 involving patients with advanced, treatment-refractory solid tumors demonstrated a manageable safety profile with no dose-limiting toxicities and evidence of disease stabilization, supporting its potential as a targeted therapy for FAP-positive malignancies.

Other names: Lutetium (177Lu) RTX2358[177Lu]Lu-RTX2358

Targets

FAP (Fibroblast activation protein alpha)

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