Phase 1/2 study of UCB6114 in Patients with Advanced solid tumours
Research type
Research Study
Full title
A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
IRAS ID
274398
Contact name
Debashis Sarker
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2019-002598-78
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 15 days
Research summary
Despite advances in the treatment regimens in the last decade, there is still a large unmet need in cancer treatment. This study is looking at a new experimental drug named UCB6114 for the treatment of advanced solid tumours in cancer patients. UCB6114 is a type of protein called an “antibody” (IgG4P) and it has shown effectiveness in neutralising another protein (Gremlin-1) produced by the tumour. Due to this activity, it is considered there is a therapeutic potential with UCB6114 to slow or stop the worsening of advanced solid tumours. The primary aim is to determine the best tolerated & effective dose. It is the first time the study drug will be given to patients with this condition so this study will assess how the study drug is broken down by the body.
This Phase 1/2 study is divided into several parts. Part A involves up to 5 groups of patients where each group will receive one of five different doses of the study drug being investigated. The dose will escalate with each successive group of patients. It is expected that 15 - 42 patients in total across 6 clinical centers throughout the United Kingdom will participate.
The patients will have study visits to assess eligibility, obtain consent, conduct blood/urine tests, electrocardiogram, echocardiogram, optional tumour biopsy and imaging assessments. Treatment will be given to the patient once every two weeks through a needle into a vein.
Patients' may stay on the trial and study drug continued whilst they are showing clinical benefit and tolerating the study drug.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1926
Date of REC Opinion
17 Feb 2020
REC opinion
Further Information Favourable Opinion