NCT06172478

Solid tumors are malignant growths that can develop in various organs of the body, such as the breast, lungs, stomach, pancreas, skin, or other organs. If the disease is locally advanced—meaning it can no longer be surgically removed—or if metastases have already formed in other parts of the body, a cure is generally no longer possible. In these cases, the goal of treatment is to control the disease for as long as possible and to maintain quality of life. Patients whose disease continues to progress despite previous therapies often have only limited further treatment options. The study drug patritumab deruxtecan (HER3-DXd) is a so-called antibody-drug conjugate in which an antibody that specifically binds to the HER3 receptor (human epidermal growth factor receptor 3) on the surface of tumor cells, is linked to a chemotherapy agent (a topoisomerase 1 inhibitor). This conjugation allows the active ingredient to be transported specifically to the tumor cells and released there, thereby largely sparing healthy tissue. The drug is still undergoing clinical trials for these conditions.

The goal of this Phase 2 study is to investigate the efficacy and safety of the antibody-drug conjugate patritumab deruxtecan (HER3-DXd) as a monotherapy for various locally advanced or metastatic solid tumors. All patients will receive the study medication HER3-DXd as an intravenous infusion every three weeks. This is an open-label (unblinded) study without a control arm; that is, all patients will be treated with the study drug, and both the patients and the study physicians will know which treatment is being administered. The study examines different types of cancer in separate groups (cohorts), including skin cancer (melanoma), head and neck cancer, stomach cancer, ovarian cancer, cervical cancer, endometrial cancer, bladder cancer, esophageal cancer, pancreatic cancer, prostate cancer, lung cancer, and breast cancer. The main objective (primary endpoint) of the study is to determine the response rate to treatment—that is, the proportion of patients in whom the tumor shrinks or disappears as a result of therapy. The follow-up period for individual patients in the study is up to approximately 27 months. In addition, tolerability, duration of response, and overall survival will be assessed. The study will also investigate whether the amount of the HER3 receptor on the tumor cells is associated with treatment success.

Women and men aged 18 and older with locally advanced or metastatic cancer who have already received at least one prior course of treatment are eligible to participate in this study. The types of cancer eligible for inclusion in the study include, among others, breast cancer, lung cancer, skin cancer (melanoma), stomach cancer, ovarian cancer, cervical cancer, endometrial cancer, bladder cancer, esophageal cancer, pancreatic cancer, prostate cancer, and head and neck cancer.