Clinical Trial for Recurrent or Inadequately Treated Breast Cancer: Is the novel drug ICT01 an effective option as monotherapy or in combination with pembrolizumab?

Cancer is a disease in which cells multiply uncontrollably and displace and destroy healthy tissue. This is also true of breast cancer. As a result, the body is damaged and treatment becomes necessary. When these tumors reach a certain size or have spread to a certain extent, the cancer is considered advanced. The disease is considered metastatic when the tumor cells have spread to other parts of the body. There are various strategies for treating cancer, including surgical removal of the tissue, radiation therapy, chemotherapy, and targeted therapies, usually involving medications. Cancer can return after treatment (recurrence), which leads to a challenging treatment situation.

Participation in this study offers patients the opportunity to explore a new treatment option. The drug ICT01 is an antibody that activates certain immune cells, known as gamma-delta T cells, which can specifically recognize and destroy cancer cells.

The goal of the EVICTION study is to investigate whether ICT01, either alone or in combination with pembrolizumab—an already approved checkpoint inhibitor—is effective and safe. To this end, side effects and treatment-related events will be monitored for up to one year after the start of treatment. The study consists of two phases: In Phase 1, the optimal dose of ICT01 will be determined, both as a monotherapy and in combination with pembrolizumab. Patients will receive an infusion every three weeks; a total of six different dosages will be tested. In Phase 2, the treatment’s efficacy will be examined in more detail across various types of cancer, including solid tumors such as breast cancer and certain blood cancers. In total, there are two study arms for both phases (Group 1: ICT01; Group 2: ICT01 and pembrolizumab); assignment is random and known to both patients and medical staff (open-label).

Women and men aged 18 and older who have advanced or recurrent cancer—such as breast cancer—that has not responded adequately to standard therapies are eligible to participate in the study. Life expectancy must be at least three months.