Drug Trial: BMS-986340 (new drug) as a Potential New Treatment for Previously Treated, Advanced, Triple-Negative Breast Cancer

Malignant solid tumors are cancers in which uncontrolled cell proliferation leads to the formation of a tumor in a specific organ or tissue, such as the breast. The specific treatment depends on various factors. In the case of breast cancer, these include the patient’s overall health, the stage 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 neither hormone receptors nor HER2 receptors are detectable on the breast cancer cells, the cancer is referred to as triple-negative breast cancer, which is usually more difficult to treat, especially if the disease is advanced or the tumor has already formed secondary tumors elsewhere in the body (metastases). Newer forms of therapy include, for example, antibodies that recognize receptors on the cell surface and specifically target the tumor.

BMS-986340 is a new antibody that binds to the C-C chemokine receptor type 8 (CRR8), a surface receptor on specific cells of the body’s immune system. These immune cells have migrated into the tumor tissue and are supposed to trigger an attack on the tumor by specialized immune cells. However, due to a malfunction, this does not occur. BMS-986340 inhibits these specific cells, allowing the immune system to attack the tumor again. The active ingredient has not yet been approved for treatment. Nivolumab is a checkpoint inhibitor that binds to immune cells and activates them. Docetaxel is a chemotherapy drug. Both drugs are already approved and are being used in this study.

The goal of this Phase 1 study is to investigate the safety and efficacy of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in individual patients, and to determine the optimal dose for further studies. The study consists of two phases. First, monotherapy with BMS-986340 or combination therapy with nivolumab or docetaxel will be administered to individual patients. The dose will be increased gradually. Based on the side effects that occur, the most effective and safest dose will be determined for the second part of the study. In this phase, additional patients will receive BMS-986340 or BMS-986340 plus nivolumab or docetaxel at the previously determined dosage. The study is open-label, meaning that both the medical staff and the study participants know which medications are being administered. The treatments and follow-up examinations as part of the study will take place over a period of up to approximately 2.5 years, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated. The key factor is whether or when the disease progresses again during treatment.

Women and men aged 18 and older with triple-negative breast cancer or another solid tumor can participate in this study. The disease must have been previously treated, must already be advanced or metastatic, and must show signs of recurrence. In addition, participants must be unsuitable for further standard treatment.