GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

To be considered for this study, generally, you must be at least 18 years old. Your cancer must be a solid tumour that has spread to other parts of the body or cannot be removed by surgery, and standard treatments are not working or are not available for your particular situation. You will need to be well enough to take part, as assessed by your doctor, and have body functions like your liver, kidneys, heart, and bone marrow working adequately.

There are specific types of cancer being studied. For example, if you have certain types of melanoma, non-small cell lung cancer, or bowel cancer that is advanced or has come back after previous treatment, you might be eligible for the part of the study where GEN1042 is given alone. For the part where GEN1042 is combined with other medicines, you might be eligible if you have certain advanced melanoma, non-small cell lung cancer, head and neck cancer, or pancreatic cancer, and you haven't yet received treatment for your widespread or recurrent cancer.

You would not be able to join if you have recently received other anti-cancer treatments, including chemotherapy or radiotherapy, within a certain period before the study starts. You also wouldn't be able to join if you still have serious side effects from previous cancer treatments that haven't cleared up.

If you decide to take part, you would receive GEN1042, either by itself, or with pembrolizumab, or with pembrolizumab and chemotherapy. The average length of time someone is in the study is about 2 years and 4 months, though the actual treatment period could be up to 2 years while you are on the GEN1042 and pembrolizumab combination. Your treatment will continue as long as it is helping you and you are not experiencing unacceptable side effects.

Initially, you would visit the hospital weekly for treatments and check-ups. Over time, these visits would become less frequent, eventually happening once every three weeks. There is also an option to continue receiving the study medicine for up to two years after your first dose, if it is still benefiting you. During your visits, doctors and nurses will monitor your health closely, take blood tests, and assess how the treatment is affecting your cancer and your body.