Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western) has dosed its first three patients as part of the launch of a Phase I clinical trial using a novel antibody to treat patients with advanced solid tumors.
CTCA at Western — located in Goodyear, west of Phoenix — is the first site in the world to administer this new antibody, TSR-022, which works by uncloaking the cancer so that the body’s own immune system can attack the tumor.
The initial goal of this clinical trial will be to study this compound’s optimum dosage, safety and effectiveness.
“We believe TSR-022 is a promising new investigational agent that could have a beneficial effect on multiple types of cancer,” said Dr. Glen Weiss, director of Clinical Research and Medical Oncologist, at Western and the principal investigator of this study. “Our hospital facility in Goodyear is the first to offer this investigational agent to our patients.”
Once the proper dosage is set, the study will expand to include patients with select tumor types.
TSR-022 was developed by TESARO Inc. of Waltham, Mass., in collaboration with AnaptysBio Inc. of San Diego. TSR-022 is an anti-TIM-3 monoclonal antibody, one of a new class of anti-cancer drugs focused on immune system checkpoints.
Immune checkpoints are a normal part of the body’s immune system, crucial for minimizing collateral tissue damage during immune responses to such threats as viruses, bacteria and other infections. But immune checkpoints can be co-opted by cancer cells to shield the tumor from the body’s immune system.
TSR-022 provides a blockade of immune checkpoints, specifically the TIM-3 molecule that inhibits the immune system’s T-cells, leaving the immune system free to attack the cancer.
One arm of this clinical trial will test TSR-022 alone, while another arm will test TSR-022 in addition to an anti-PD-1 antibody, another type of immune checkpoint blockade.
In Phase I of clinical trials, researchers test a treatment in a small group of patients for the first time to evaluate its safety, determine a safe dosage range and identify side effects. In Phase II, the treatment is given to a larger group of patients to see if it is effective and to further evaluate its safety.