The first “in-human” trials of various new cancer treatments led by the University of Cincinnati Cancer Institute will begin in the coming days as they prepare to move from the lab to the clinic.

The research led by Dr. Olivier Rixe, a clinical professor for UC’s College of Medicine, will use a new experimental technology, antibody-drug conjugate (ADC), and a new experimental drug called AMG 595 to experiment with new treatments for cancer.

“It [ADC] is an antibody conjugate protein loaded with a toxin; this protein is able to identify targets of a cancer cell, then the toxin is released into the tumor cell and just kills the cell,” Rixe said. “By definition, it is very, very toxic; when you use toxin alone it can be toxic to the patient.”

When using the toxin ADC and lowering the concentration it can be much more useful, Rixe said.

AMG 595 is intended to target certain mutated-cell receptors on the surface of tumor cells.

“Phase 1: We move from the lab to the clinic,” Rixe said. “We will start with a small dose and increase until we see some toxicity and reach ADC concentration in the blood. We then expand to additional patients if we see primary activity and it is safe. Then we will move to phase 2, then phase 3: Study, and, if successful, we hope to get Food and Drug Administration approval to continue to move forward.”

The trials were approved in January, and in the coming days trials will begin for the 60 patients who enrolled for trials in the United States and Australia.

“We have patents with primary brain tumors — very aggressive tumors called malignant gliomas, and frontline treatment has few options,” Rixe said.

Patients who had previously unsuccessful treatments were able to qualify for the trial.

“For the past 20 years, cancer has had treatments of chemotherapy, surgery and radiation,” Rixe said. “Now we open the door for new avenues because we characterize specific abnormalities [and] new designed drugs to target cancer cells. It is a new process and we have high expectations.”

The goal is to demonstrate that the drug is safe, Rixe said.
Funding for the research comes from the UC Cancer Institute as well as other grants.