17845 Phase 1 dose-escalation study of BAY 1862864 Injection
Research type
Research Study
Full title
An open-label phase I, dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose, biodistribution, radiation dosimetry and pharmacokinetics of BAY 1862864 Injection in subjects with relapsed or refractory CD22-positive non-Hodgkin’s lymphoma
IRAS ID
183140
Contact name
Andrew John Davies
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-004140-36
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
The purpose of this study is to establish a recommended dose of BAY 1862864 Injection and to investigate how the study drug acts in the body, on the cancer cells and how safe it is in patients with advanced non-Hodgkin’s lymphoma.
The study consists of two parts: 1) The “dose-escalation part” in which different doses of the study drug will be tested. 2) The “expansion part” in which one of the tested doses will be selected for further investigation.
The study drug being tested is called BAY 1862864 Injection. It consists of an antibody (a protein) linked to thorium-227. The antibody binds to another protein (called CD22) on the surface of some cells. The thorium-227 emits alpha radiation which causes cell damage. This alpha radiation given by thorium-227 travels only a very short distance in the body and will therefore act mainly on the areas to which the antibody binds.
Different doses of radioactivity (alpha radiation) and protein dose (antibody) will be tested.
It is expected that up to approximately 60 patients with non-Hodgkin’s lymphoma will participate (30 in each part of the study) at several centres in Europe, including 2 in the UK.
Patients will be in the study for approximately 18 months. There will be four treatment cycles, lasting 42 days each, and BAY 1862864 Injection will be administered on Day 1 of each cycle. A safety follow-up visit will take place 12 weeks after the last injection of BAY 1862864 Injection, with a final safety follow up (by telephone) 12 months after last study treatment.
Assessments performed during participation will include physical examinations, ECGs (electrocardiograms), CT, MRI or PET-CT scans, blood and urine samples, tumour biopsies and bone marrow biopsies.
The study is funded by the sponsor Bayer HealthCare AG, D-51368 Leverkusen, Germany.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0614
Date of REC Opinion
20 Aug 2015
REC opinion
Favourable Opinion