WP42004 - Phase 1 of RO7283420 in Acute Myeloid Leukemia
Research type
Research Study
Full title
An Open-Label, Multi-Center, Phase I Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of RO7283420 As A Single Agent In Hematologic And Molecular Relapsed/Refractory Acute Myeloid Leukemia
IRAS ID
286218
Contact name
Paresh Vyas
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-000216-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 15 days
Research summary
Adult Acute Myeloid Leukemia (AML) is the most aggressive blood cancer. Although some progress has been made in recent years in the development of new therapies, AML remains a fatal disease for ~80% of patients and usually within 6 months of diagnosis.
To bring new therapies for AML patients, we propose to conduct a first-in-human study is to test the safety of RO7283420, a drug designed to activate or support the body’s own immune system in identifying and destroying leukemia cells. The drug is a called an antibody. An antibody is a protein. Many antibodies drugs are successfully in use to treat a variety of medical conditions.
The aim of this trial is to test RO7283420, at different dose levels and to find out what if RO7283420 safe and if there is any preliminary evidence that it kills AML cells and prolongs life. All patients who will be eligible for this trial will have already had standard treatment and have exhausted all options to survive – they have what is relapsed/refractory AML.
This trial has three parts, parts A, B and C. In Part A single participants who have relapsed/refractory AML will receive an increasing dose of RO7283420, starting at a low dose initial dose. In this way a minimum number of patients receive doses that are ineffective. In Part B multiple participants with relapsed/refractory AML will receive an increasing dose of RO7283420 until the safe dose with hopefully some evidence of preliminary efficacy is determined. In Part C, participants in with relapsed/refractory AML will receive RO7283420 from Part B.The study will last approximately 21 months. We anticipate approximately 15 patients recruited at 3 UK sites and a 160 patients will take part in the study
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1.0 16-Jul-2019
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0246
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion