Study to Evaluate the Safety, Tolerability, and Efficacy of a New Drug (Name: IMA401) in Patients with Recurrent or Uncontrolled Breast Cancer

Solid tumors are growths of tissue that can occur anywhere in the body. Malignant solid tumors invade healthy tissue, displace it, and can spread to other parts of the body via the blood and lymphatic systems (metastasis). In addition to traditional chemotherapy, modern targeted therapies and immunotherapies are also used in treatment. The IMA401-TCER study is testing a new drug called IMA401, which utilizes bispecific T-cell receptor molecules (TCER®). These molecules help the body’s own T cells to specifically target and attack cancer cells. The mechanism of action of IMA401 is based on binding to two different target structures: a receptor on the body’s own immune cells (T cells) and a specific surface protein (antigen) found on cancer cells (MAGEA4/8). This dual binding allows T cells to more easily recognize and kill the cancer cells. Since the drug specifically targets tumors expressing this particular surface protein, study participants must have this antigen (MAGEA4/8) on their tumor cells, which is verified in advance through testing.

The IMA401-TCER study is a Phase 1 trial aimed at determining the maximum tolerated dose of the drug and evaluating the safety of the treatment. In a second part, the recommended dose will be tested in a larger group of patients to obtain initial evidence of efficacy. All study participants will receive the same treatment (a single study arm) and will be aware of it (open-label study). The study will be conducted over more than 7 years to observe both the short-term and long-term effects of the treatment.

It is divided into two phases, with Phase 1a followed by Phase 1b. Phase 1a is designed to determine the appropriate dose of the medication. Here, study participants are divided into one of two groups. Group 1 receives monotherapy with IMA401. Group 2 receives combination therapy with IMA401 and pembrolizumab. In Phase 1b, monotherapy with IMA401 will continue at the determined, tolerable dose.

Eligible participants include women and men aged 18 and older with a confirmed, advanced, or metastatic solid tumor that no longer responds to standard therapies. The tumor cells must be HLA-positive and express the MAGEA4/8 antigen on their surface. Patients with other active cancers or serious health problems are not eligible to participate in the study.