BT1718 in Patients with Advanced Solid Tumours.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

November 20, 2023

Study Completion Date

November 20, 2023

Conditions
Advanced Solid TumoursNon-Small Cell Lung CancerNon-Small Cell Lung SarcomaOesophageal Cancer
Interventions
DRUG

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.

Trial Locations (6)

B15 2GW

Queen Elizabeth Hospital, Birmingham

Unknown

Addenbrookes Hospital, Cambridge

The Beatson Hospital, Glasgow

The Christie Hospital, Manchester

SM2 5PT

Royal Marsden Hospital and The Institute of Cancer Research, London

W1T 7HA

University College London Hospital NHS Foundation Trust, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bicycle Therapeutics

UNKNOWN

lead

Cancer Research UK

OTHER