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City of Hope has opened its first-in-human clinical trial for an investigational therapy in patients with advanced breast cancer.
City of Hope recently announced the opening of a phase 1 clinical trial for an investigational therapy in patients with metastatic triple-negative breast cancer. The trial is a first-in-human analysis of using an oncolytic virus, which is a cancer-killing virus, to treat patients.
The researchers at City of Hope created a genetically engineered therapy, CF33-hNIS-antiPDL1, from the naturally occurring oncolytic virus. The therapy is intended to infect, replicate and kill cancer cells while leaving healthy cells untouched.
“The study is designed to determine the safety and optimal biological dose that may induce an immune response in triple-negative breast cancer tumors,” said Dr. Yuan Yuan, associate professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and principal investigator of the trial, in a release. “Current approved therapies do not offer a cure for this aggressive type of breast cancer, which often becomes resistant to chemotherapy. Clinical trials like this one seek durable responses and better quality of life for patients.”
The trial is expected to examine whether the therapy is safe and effective in 78 patients whose disease has progressed past standard-of-care chemotherapy. It is expected to last for three years, and enrollment is currently open for patients. Treatment will be given in three cycles of six doses through direct injection into the tumor.
“It is an exciting time in immuno-oncology. Preclinical research has shown that this oncolytic virus can direct the killing of cancers and stimulate the immune system to enable further killing of cancers,” said Dr. Yuman Fong, the Sangiacomo Family Chair in Surgical Oncology at City of Hope who developed CF33, in a news release. “This trial is an important step forward.”
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