72
Participants
Start Date
January 24, 2018
Primary Completion Date
November 20, 2023
Study Completion Date
November 20, 2023
BT1718
Dose escalation will consist of Stage 1 and 2. Stage 1 patients will receive BT1718 intravenously twice a week (D: 1,4,8,11,15,18) for 3 out of 4 weeks. Starting dose will be 0.6mg/m2. Single patient cohorts will be explored, but it will change to 3 to 6 patients cohorts. Stage 2 patients will receive BT1718 intravenously once a week (D: 1,8,15) for 3 out of 4 weeks. This stage will have 3 to 6 patient cohorts until the recommended dose is established. The expansion phase will consist of two or more expansion cohorts to include tumour types known to commonly over-express MT1-MMP and where MT1-MMP overexpression is confirmed during prospective and retrospective (in appropriate patients) selection at enrolment. A squamous NSCLC and basket cohort will include approximately 16 patients each with high MT1-MMP levels. In the expansion cohorts BT1718 will be administered intravenously at the once weekly RP2D established in Phase I, Stage 2.
Queen Elizabeth Hospital, Birmingham
Addenbrookes Hospital, Cambridge
The Beatson Hospital, Glasgow
The Christie Hospital, Manchester
Royal Marsden Hospital and The Institute of Cancer Research, London
University College London Hospital NHS Foundation Trust, London
Lead Sponsor
Collaborators (1)
Bicycle Therapeutics
UNKNOWN
Cancer Research UK
OTHER