ATR inhibitor elimusertib(BAY1895344) plus radiotherapy in recurrent or newly diagnosed glioblastoma
Research type
Research Study
Full title
A non-randomized, open-label, Phase 1b study of the ATR inhibitor elimusertib (BAY 1895344) in combination with radiotherapy in participants with recurrent or newly diagnosed glioblastoma
IRAS ID
1004130
Contact name
Markus Lindqvist
Contact email
Sponsor organisation
Bayer AG
Eudract number
2021-002851-13
Research summary
This study tests the drug elimusertib given in combination with radiotherapy. Elimusertib works by blocking an enzyme (a protein in cells which works to speed up chemical reactions in the body) called ATR (Ataxia Telangiectasia and RAD3-related) kinase that is important for the growth of cancer cells.
The study consists of two parts: The purpose of part 1 is to learn if the combination of elimusertib (new drug) and radiation therapy (approved by health authorities) is safe for participants, how it affects the body and to try to find the best dose of elimusertib to be administered. We are also looking in this study at how the drug moves into, through and out of the body. This is called “Pharmacokinetics”. In part 2 we are looking at how the body delivers elimusertib to participants’ brain tumor.
Part 1 is further divided into two parts: Part 1A for participants with recurrent glioblastoma and Part 1B for participants with newly diagnosed glioblastoma where the tumor has a particular feature, referred to as “unmethylated MGMT” (O6-methylguanine-DNA methyltransferase promoter status or uMGMT).
Participants enrolled for Part 2 of the study will take one dose of elimusertib before the planned surgery. Once they finish Part 2, the doctor will decide the best treatment to continue with. This may also include continuing to Part 1A or Part 1B of the study if eligible.
Participants will receive elimusertib in tablet form to be swallowed. Radiotherapy will be given (administered) at the hospital/clinic.
Participants will first be treated with the combination of elimusertib and radiotherapy for 2 weeks (Part 1A) or 6 weeks (Part 1B), followed by a 4-week treatment-free break period. They will then enter an adjuvant period consisting of elimusertib administration by itself, until the study doctor considers participants not benefitting from the treatment.REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0754
Date of REC Opinion
30 Nov 2021
REC opinion
Further Information Favourable Opinion