BP43131 - RO7443904 and Glofit in Relapsed BCell NonHodgkins Lymphoma
Research type
Research Study
Full title
AN OPEN-LABEL, PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF RO7443904 IN COMBINATION WITH GLOFITAMAB IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA
IRAS ID
1004334
Contact name
Abira Suganthan
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-003757-33
Research summary
Non-Hodgkin lymphoma (NHL) is one of the leading causes of cancer death in the United States and in Europe.
The lack of curative outcomes for many patients with both indolent and aggressive NHL subtypes remains an unmet medical need, despite significant advances in immune-therapeutics that have extended progression-free survival (PFS) times.
This is a Phase 1, first in human study of RO7443904 in non-Hodgkin’s lymphoma. The aim of this study is to find out whether RO7443904 at different dose(s) when given together with glofitamab has any effects (good or bad) on non-Hodgkin’s lymphoma, and what happens to RO7443904 once it is in the body.RO7443904 will be administered by IV or SC infusion in combination with glofitamab. This study is divided into a dose-escalation stage (Part 1 to Part 3) and a dose expansion stage (Part 4).
Male and female participants aged > 18 years and body weight > 40 kg, have a life expectancy of > 12 weeks and are willing and able to participate and consent are eligible for screening.
There will be approximately 200 participants globally, with 8 of them being in the UK at 1 site. The study will last approximately 2 years and 4 months.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1 20-OCT-2021;REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0847
Date of REC Opinion
18 Jan 2022
REC opinion
Further Information Favourable Opinion