A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody against Integrin ?v?8, in Patients with Advanced Solid Tumors (CRB-601-01)

This research involves an early phase clinical trial, which is testing a new intravenous therapy (CRB-601) for advanced cancer that targets a protein, called integrin alpha-v, beta-8, in humans for the first time. This protein is important, because it can stimulate the release of another inflammatory protein that has been shown to promote cancer growth. In this trial, one of the aims is to find the maximum dose that can be given to patients and at what level it is active. The trial will then try to find the best dose for this drug when given in combination with other therapies that are used to boost the immune system against cancer (an immunotherapy, called cemiplimab). Finally, the aim will be to find the best dose that may be given in combination with immunotherapy and a targeted radiotherapy treatment (stereotactic body ablative radiotherapy). The patients who may be recruited to this study will have cancers that have come back or have not responded to at least one standard treatment. Patients will be asked to attend hospital for treatment and regular assessments, including imaging scans. The benefits include the possibility of receiving a new therapy at an early stage, which may prove to be more effective than existing treatments. However, the risks include potential side effects, some of which may be serious or unknown, and the inconvenience of additional hospital visits and tests.