NCT03486730

BT1718 in Patients with Advanced Solid Tumours.

A Cancer Research UK Phase I/IIa Clinical Trial of BT1718, (A Bicycle Drug Conjugate) Given Intravenously in Patients with Advanced Solid Tumours.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is looking at a drug called BT1718 in adult patients with advanced solid tumours. The main aim of the study is to find the maximum dose of BT1718 that can be given safely to patients; learn more about the potential side effects of BT1718 and how they can be treated and also what happens to BT1718 inside the body.

Detailed description

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.

Conditions

• Advanced Solid Tumours
• Non-Small Cell Lung Cancer
• Non-Small Cell Lung Sarcoma
• Oesophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-24
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2018-04-03
• Last updated: 2024-10-24

Locations

6 sites across 1 country: United Kingdom