This phase 2 trial will investigate the safety and effectiveness of tisotumab vedotin (TTV) for the treatment of solid tumors. The main outcome will be the response rate to treatment. This trial will take place in the United States, France, and Italy.
The details
Colorectal cancer (CRC) is caused by excessive cell growth in the colon and rectal area. Some cancers are difficult to treat. New drugs are under investigation for many cancers. These include antibody-drug conjugates (ADCs). ADCs are a combination of two components. The antibody (Ab) targets a specific protein in the cancer cells. A drug is attached (or conjugated) to the Ab. When the Ab binds the protein, the drug can cause the cancer cell to die. ADCs are more specific than classic cancer drugs. There may also be fewer side effects with these drugs.
Tisotumab vedotin (TTV) is an ADC. It binds to a protein called tissue factor (TF). A cytotoxic (cell-killing) drug called MMAE then kills the cell.
This trial will investigate the safety and effectiveness of TTV for the treatment of solid tumors. The main outcome will be the response rate to treatment.
Who are they looking for?
This study will recruit 200 patients. Patients with colorectal, non-small cell lung cancer and some other cancers are eligible for the trial. Patients must have advanced cancer.
Patients cannot take part in the trial if they have active bleeding conditions. If the patient develops another type of cancer during the trial then they cannot continue. Other exclusion criteria include eye disease, lung disease, brain tumors, tumor-related pain or peripheral nerve disease. Patients who are breastfeeding, pregnant or intending to become pregnant cannot take part.
How will it work
All patients will receive TTV. It will be administered at a dose of 2 mg/kg every 3 weeks. This will be done by intravenous infusion. This study will continue for up to 2 years. Patients will be monitored for adverse events during the study.
