AMG 211 (also known as MEDI-565) is a recombinant bi-specific antibody with the potential to increase the ability of the immune system to eliminate cancer cells.

It is being developed by Amgen, and currently being tested in people with gastrointestinal cancer.

How AMG 211 works

AMG 211 is a recombinant antibody directed against two different proteins: human carcinoembryonic antigen (CEA) and the CD3 complex.

CEA is a tumor-associated protein produced in excess by many cancers, including gastrointestinal, breast, non-small cell lung and thyroid cancer. The CD3 complex is a group of proteins found on the surface of immune cells called T-cells.

By binding to both CEA and CD3 at the same time, AMG 211 helps to recruit T-cells to tumor sites, a process that can result in the death of CEA-expressing tumor cells.

AMG 211 in clinical trials

A Phase 1 clinical trial (NCT01284231) assessed the safety and tolerability of AMG 211 in people with gastrointestinal adenocarcinomas. The study aimed to find the maximum tolerated dose of AMG 211 and assess how the body responded to it. That maximum dose was identified as 5 mg. Side effects associated with the treatment included diarrhea, vomiting, fever, and infusion reaction.

An ongoing Phase 1 study (NCT02291614) is assessing the anti-tumor activity of AMG 211 in people with gastrointestinal adenocarcinoma that has returned or failed to respond to other treatments. The study aims to find out how long AMG 211 stays in and acts on the body, and how the body responds to it. Investigators will also monitor potential side effects caused by the treatment, assessed through changes in vital signs, electrocardiograms (ECG), physical examinations, and laboratory tests. A total of 51 participants have been enrolled at trial sites in Germany and The Netherlands. It is expected to finish in January 2018.

Finally, the Phase 1 trial (NCT02760199) evaluated the usefulness of radioactive labeling of AMG 211 in identifying patients who may be more likely to benefit from treatment. The uptake and distribution of radio-labeled AMG 211 in primary and metastatic tumor lesions and normal organs was visualized by PET scan. PET scan was also performed during AMG 211 treatment, to assess the impact of prolonged AMG 211 exposure on tumor and tissue uptake.

Results of the trial, which concluded in May 2017, have not yet been published. However, preclinical evaluation of radio-labeled AMG 211 showed that it targeted the tumor in a dose-depend way, supporting the tracer’s use as a means to evaluation how well AMG 211 is taken up in primary and metastatic tumor sites and in healthy organs.


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