BT1718 in Patients with Advanced Solid Tumours.

BT1718 is a type of drug called a 'bicycle drug conjugate' which is designed to target and inhibit the function of the protein 'membrane type 1 metalloproteinase' (MT1-MMP). MT1-MMP is involved in breaking down the proteins that usually surround a cell; however in cancer cells it can allow a cancer to grow and spread. MT1-MMP is usually found at a low level in normal cells, but can reach higher levels in cancer cells. BT1718 has been designed to recognise and attach itself to the MT1-MMP protein. Once attached a segment of BT1718 is taken into the cancer cell which causes it to die (DM1 toxin). This is a first in human clinical study which has two phases. A 'dose escalation' phase where groups of patients will receive increasing doses of BT1718 to find a safe dose that best targets the cancer cells. In this phase it is expected that approximately 50-60 patients with advanced solid tumours will be entered in the study. An 'expansion phase' where larger groups of patients will receive the selected dose of BT1718 to allow us to find out more about how the drug is working. In this phase at the optimal dose/schedule(s), patients will be enrolled with tumour types known to commonly overexpress MT1-MMP and where MT1-MMP overexpression is confirmed during prospective and retrospective (in appropriate patients) selection at enrolment (i.e. squamous non-small cell lung cancer). It is expected that up to an additional 70 patients will be required to complete this phase.