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BT1718 in Patients with Advanced Solid Tumours.

NCT03486730 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2023-11-20
Completion
2023-11-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486730 on ClinicalTrials.gov