Drug intelligence / Profile preview

[177Lu]Lu-SmartD2

Development stage
Unknown
Lead developer
SmartNuclide
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Beta-minus Emitters → Radiopharmaceuticals, Gamma Emitters → Radiopharmaceuticals, Small Molecules
Administration
Intravenous
01

Overview

[177Lu]Lu-SmartD2 is a novel bivalent lutetium-177-labeled DOTA-based chelator developed by SmartNuclide Biotech. It serves as the radiolabeled effector molecule in the company's proprietary SmartCC platform, a two-step pretargeted radioimmunotherapy (PRIT) strategy. In this pretargeting approach, a tumor-targeting bispecific fusion protein (such as GPA33-CC or CA9-targeting SmartCC) is administered first to localize and accumulate at the tumor site. After the unbound targeting protein clears from the circulation, [177Lu]Lu-SmartD2 is administered. It binds with high affinity to the pre-localized bispecific protein, delivering targeted beta-particle radiation to the tumor while minimizing systemic exposure and renal toxicity. Preclinical studies have shown that the bivalent design of [177Lu]Lu-SmartD2 provides significantly prolonged tumor retention and higher tumor uptake compared to monovalent alternatives like [177Lu]Lu-DOTA-Bn-SCN. It is currently in Phase I clinical development as part of the SNA028 regimen for the treatment of GPA33-positive advanced colorectal cancer.

Other names
177Lu-SmartD2[177Lu]Lu-SmartD2

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