This trial is examining the safety and effectiveness of experimental drug mRNA-2752 in patients with advanced triple-negative breast cancer. The main outcome of the trial will be the number of side effects experienced by patients and response to treatment. This trial is recruiting in the United States and Israel.
Patients with advanced or metastatic cancer (cancer that has spread) often do not respond sufficiently to available treatments. Therefore treatments that work differently are needed. mRNA-2752 is a treatment where a piece of RNA (similar to DNA) is injected into tumors. This then makes three proteins in the tumor. These three proteins activate and direct the patient’s immune system to kill the cancer cells.
PD-L1 is a molecule used by some cancers to block the activation of the patient’s immune system. Durvalumab (Imfinzi) is a biological drug that can block cancer cells from using PD-L1. This trial will examine the safety and effectiveness of mRNA-2752 with or without durvalumab in patients with advanced cancer.
Who are they looking for?
This trial is recruiting 126 patients with advanced cancer, including triple-negative breast cancer. Cancer must have progressed on standard therapy. Patients must have at least one measurable tumor. Patients’ body weight must be 30 kg or more. Patients must have a healthy blood count.
Female patients within childbearing years must not be pregnant or breastfeeding. Patients who received treatment for cancer within 28 days of the trial start date cannot participate. Patients who received immunosuppressant drugs within 14 days of the trial start date cannot participate. Patients with tumors in the brain or spine cannot participate. Patients with autoimmune or inflammatory diseases cannot participate. Patients with a history of immunodeficiency, tuberculosis or those that previously received transplants cannot participate. Patients with certain infections including Hepatitis B and C and HIV cannot participate. Patients with heart disease, gut disorders, certain psychiatric disorders, and bleeding disorders cannot participate.
How will it work
Patients will be divided into 2 groups. The first group will receive mRNA-2752. The second group will receive mRNA-2752 and durvalumab.
The side effects of the dose of mRNA-2752 will be measured for 28 days. The side effects of the whole treatment will be measured up to 3 months after the last treatment dose. Patients' response to treatment will be measured for 180 days after the last treatment dose. Tumor production of the three proteins made by mRNA-2752 will be measured for 58 days after the start of the trial. Levels of mRNA-2752 in the blood will be measured for 29 days after the start of the trial.