A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

To join this study, you would need to have bowel cancer that has spread to other parts of your body (metastatic colorectal cancer). Your doctors must have confirmed this with a tissue sample (biopsy). You should have already received and tried some standard cancer treatments for your advanced cancer, but no more than two different types of treatments in total for the spread cancer, and your cancer must have continued to grow despite these treatments.

You also need to be generally well enough to take part. This is often checked using a score called ECOG, and for this study, you need a score of 1 or less, meaning you are able to carry out most daily activities. You must also be able to swallow tablets and be able to attend all the scheduled study appointments and tests.

There are also some reasons why you might not be able to join. For example, if you've had certain side effects from previous treatments that haven't healed fully, or if you've had another type of cancer within the last three years. You also can't join if the cancer has spread to your brain, or if you've had certain bowel problems recently, such as a tear in your bowel or a blockage, or conditions like Crohn's disease or ulcerative colitis that could affect how you absorb the study drugs.

If you decide to take part in this study, you would be given one of the study treatments. This could be the new drug Precem-TcT on its own, Precem-TcT combined with bevacizumab, or the standard treatment of trifluridine/tipiracil with bevacizumab. The treatments involve taking medication, some of which are tablets you swallow, and others might be given through a drip into your vein.

Throughout the study, you would have regular visits to the clinic. These visits will include various assessments such as blood tests, scans (like CT scans) to check the cancer, and physical examinations. These are done to see how you are responding to the treatment and to monitor for any side effects. You might also be asked to keep a diary or answer questions about how you are feeling.

The total length of your participation would depend on how your cancer responds to the treatment. You would continue receiving the study treatment for as long as it is helping and you are tolerating it well. Even after you stop the main treatment, there will be follow-up appointments, often involving phone calls or shorter visits, to monitor your health in the long term. Your study doctor and nurse will explain the full schedule of visits, tests, and medications in detail.