A new drug (designated KFA115) for the treatment of advanced or metastatic triple-negative breast cancer

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors, such as the patient’s overall health, the stage (extent) of the disease, the tumor’s growth rate (Ki-67 index), the presence of detectable hormone receptors on the surface of the cancer cells (estrogen receptor-positive, progesterone receptor-positive), and the increased expression of the HER2 receptor on the cells (HER2-positive). If the tumor cells express neither hormone receptors nor HER2 receptors, the cancer is referred to as triple-negative breast cancer. In this case, only a few targeted treatment options are available. In the locally advanced stage (Stage 3) or when metastases have already been detected in the body, the disease is often no longer curable. The goal then is to keep the disease under control for as long as possible. There is therefore a great need for new drug therapies, especially in the advanced or metastatic stages. The study drug KFA115 could represent a new treatment option in this context. The drug is a so-called immunomodulator, which is designed to inhibit the growth of cancer cells. KFA115 has not yet been approved for the treatment of cancer. Combining it with pembrolizumab could further improve treatment outcomes. Pembrolizumab is an already approved antibody (immunotherapy) that blocks the surface protein Programmed Death-Ligand 1 (PD-L1) on cancer cells. Cancer cells use PD-L1 to protect themselves from destruction by the body’s immune cells. By blocking PD-L1 with pembrolizumab, the body’s immune system can once again effectively attack the tumor.

The goal of this Phase 1 study is to determine the appropriate therapeutic dose of KFA115, initially as a monotherapy and, later in the study, as a combination therapy with pembrolizumab. Patients with various types of cancer are eligible to participate in the study, including, among others, patients with triple-negative breast cancer.

To this end, the dose of KFA115 will first be gradually increased under close monitoring, both as monotherapy and as combination therapy, to determine the safest and most effective dose. Subsequently, treatment will be administered in combination at the recommended dose. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. The treatments and follow-up examinations as part of the study are initially conducted for approximately 1 month to assess safety and dose; the total duration of participation in the study is up to approximately 3 years, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated.

Women and men aged 18 and older with advanced solid tumors are eligible to participate in this study, including those with triple-negative breast cancer. Patients with breast cancer must have previously received chemotherapy as well as treatment with sacituzumab govitecan and, in the case of a BRCA mutation, a so-called PARP inhibitor. The tumor must be hormone receptor-negative and HER2-negative (triple-negative). Patients must not have any relevant heart disease, autoimmune diseases, or lung diseases (fibrosis).