A Study of the Safety and Efficacy of PeptiCRAd-1, a Novel Immunotherapy, in the Treatment of Advanced and/or Metastatic Triple-Negative Breast Cancer

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland and is one of the most common cancers in women. The stage of the disease is crucial for treatment and prognosis—that is, the chances of recovery. If the tumor is so large that it can no longer be surgically removed or if it has already spread throughout the body (metastases), the disease is considered advanced (Stage 3 or 4). In this situation, a cure is rare, so treatment aims to control the disease for as long as possible. For this reason, new treatment approaches are being developed specifically for these patients. This study investigates a novel therapy using PeptiCRAd-1. This innovative drug combines two mechanisms of action to specifically target cancer: It uses specialized viruses that directly infect and selectively destroy cancer cells, while largely sparing healthy tissue. In addition, the viruses are specifically designed to train the immune system to target the tumor. The infected tumor cells release signals that trigger an immune response. This results in a dual effect: direct tumor destruction by the virus and an enhanced immune response against cancer cells.

PeptiCRAd-1 is often combined with checkpoint inhibitors such as pembrolizumab to further enhance the immune response. These drugs block the mechanisms by which cancer cells suppress the immune system, allowing the body’s own immune cells (T cells) to function more effectively. Checkpoint inhibitors are already approved and well-established in cancer treatment.

The goal of the START study is to investigate the efficacy of this new drug in various advanced cancers, particularly stage 3–4 breast cancer. In addition, study participants receive a single dose of cyclophosphamide, an established chemotherapy drug, at the start of treatment. The study comprises two groups: While Group 1 receives PeptiCRAd-1 injected directly and exclusively into the tumor, Group 2 receives a subcutaneous dose (under the skin) in addition to the injection into the malignant tissue. This is followed by combination therapy with pembrolizumab, which is administered intravenously. The treatment is administered a total of six times. Follow-up within the study initially lasts for about five months, during which side effects are specifically monitored.

Women and men aged 18 and older with various solid tumors, including breast cancer, in an advanced or metastatic stage are eligible to participate in the study if the tumor can no longer be surgically removed and standard therapies are no longer effective. The tumor cells must not express hormone or HER2 receptors; therefore, the breast cancer must be triple-negative. In addition, patients must be in good general physical condition, must not be receiving active immunotherapy, and must not have active brain metastases.