Patients with inoperable cancer that has spread to nearby tissues or lymph nodes may be eligible for a clinical trial of a new immunotherapy drug. 

“The trial is for patients with cancers including lung, prostate, pancreatic, bile duct and liver cancer, who have had standard treatments that did not work or the patients couldn't tolerate them,” said Hui-Zi Chen, MD, PhD, medical oncologist, Medical College of Wisconsin faculty member and principal investigator of the trial. 

“We are not restricting the type of cancer as long as it is a solid tumor and not a cancer of the blood.” Participants will receive the drug TAK-280-1501 (TAK-280), the second generation of bi-specific T-cell engagers (BiTEs). BiTEs work with the body’s T cells — white blood cells that are part of the immune system — to identify and attack cancer cells. 

“TAK-280 is a synthetic molecule engineered to recognize two proteins, one of which is found on the surface of cancer cells,” Dr. Chen said. 

“The second protein is found on a specific type of T cell that can directly kill cancer cells. The TAK-280 molecule will bind to the protein on T cells and cancer cells, bring them close together and activate the T cells to destroy the cancer.” 

The targeted approach focuses on cancer cells, which have a higher level of the proteins, sparing normal cells that have a lower level. Once TAK-280 is inside the body, an enzyme found in tumors activates it. This restricts the drug’s effect to the site of the cancer. 

“TAK-280 is a phase I study with two goals — evaluating safety and finding the right dose to give patients," Dr. Chen said. “Then, we’ll expand the trial to test effectiveness.” 

Patients receiving TAK-280 infusions are monitored in the hospital for up to 24 hours. 

“Sometimes, activating the immune system will cause problems that require treatment," Dr. Chen said. “One of the side effects is cytokine release syndrome, which causes low blood pressure and fever. It is the result of the active immune system overwhelming the body.” 

The trial is multinational. In Wisconsin, it is only available through the Froedtert & MCW Cancer Network. 

“Patients have been receptive to participating," Dr. Chen said. “When they come to an academic health network, they expect us to offer novel therapies and trials.” 

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