Drug intelligence / Profile preview

clivatuzumab tetraxetan

Development stage
Phase 2
Lead developer
Gilead Sciences
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Clivatuzumab tetraxetan (also known as 90Y-hPAM4) is a radioimmunotherapeutic agent developed by Immunomedics (later acquired by Gilead Sciences) for the treatment of advanced pancreatic adenocarcinoma. It consists of a humanized monoclonal antibody, hPAM4, which specifically targets the Mucin-5AC (MUC5AC) glycoprotein—an antigen highly expressed in pancreatic cancer but absent in normal pancreatic tissue. The antibody is conjugated to the chelator tetraxetan (DOTA) and radiolabeled with yttrium-90 (90Y), a high-energy beta-emitting radionuclide. This configuration allows for the targeted delivery of ionizing radiation directly to tumor cells, minimizing damage to healthy tissue. Clinical development reached Phase III (the PANCRIT-1 trial) where it was evaluated in combination with low-dose gemcitabine as a radiosensitizer. However, development was discontinued in 2016 after the Phase III trial failed to demonstrate a significant improvement in overall survival for patients with metastatic pancreatic cancer.

Brand names
hPAM4-CidehPAM-4-CidehPAM 4-CidePan-Cide
Other names
yttrium Y 90 clivatuzumab tetraxetan90Y-DOTA-hPAM4hPAM4-tetraxetanhPAM-4-tetraxetanhPAM 4-tetraxetan
02

Targets

MUC5AC (Mucin-5AC)

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