ATR Inhibitor BAY 1895344 in combination with pembrolizumab
Research type
Research Study
Full title
A multicenter, non-randomized, open-label phase 1b study to determine the maximum tolerated and recommended phase 2 dose of the ATR Inhibitor BAY 1895344 in combination with pembrolizumab and to characterize its safety, tolerability, pharmacokinetics and preliminary anti-tumour activity in patients with advanced solid tumours
IRAS ID
261727
Contact name
Johann de Bono
Contact email
Sponsor organisation
Bayer AG
Eudract number
2018-003420-36
Duration of Study in the UK
2 years, 1 months, 5 days
Research summary
Summary of Research
The purpose of this study is to look at the safety of BAY 1895344 when given in combination with Pembrolizumab. We will also look at how it affects the body and try to find the dose that is most effective but also safe. 76 adult participants will take part for about 7-8 months but this may be longer based on treatment response and they will visit the hospital approximately 37 times. Participants must have advanced solid tumours with DNA damage response (DDR) deficiency and have experienced disease progression after treatment with all available standard of care therapies.
The UK will take part in the expansion, Part B of the study only. The plan is to have 4 sites open in the UK. At the time of submission, 3 have been selected:-
- Prof. De Bono, Royal Marsden,London
- Dr. Plummer, Freeman Hospital, Newcastle
- Dr. Papa, Guy's Hospital, London
1 further site will be assessed and will be submitted later as a substantial amendment.Summary of Results
This is a summary of the main results for 56 participants. Individual results from each participant might be different and are not included in this summary.
The results from several studies are needed to decide which treatments work best and are safest. Other studies may provide new information or different results.How many participants had adverse events and serious adverse events? To answer this question, researchers monitored participants' health throughout the study Serious adverse events:-
- Elimusertib 40 mg Schedule 2 (out of 31) = 42% (13) Adverse events
- Elimusertib 40 mg Schedule 2 (out of 31) = 100% (31)The most common serious adverse events that happened in this study were:
- Pain in the abdomen = 3% (1)
- COVID-19 = 7% (2)
- Cancer pain = 3% (1)The most common adverse events that happened in this study were:
- Low number of red blood cells = 84% (26)
- Tiredness = 61% (19)
- Low number of neutrophils, a type of white blood cell = 58% (18)The highest dose of elimusertib that participants took with pembrolizumab in this study was 40 mg twice a day. However, researchers could not find the recommended dose of elimusertib that could be safely taken with pembrolizumab in future studies.
How many participants responded to treatment with elimusertib and pembrolizumab during the study?
To answer this question, researchers took images of the participants’ tumors and/or did blood tests to assess the spread of cancer before and after starting the study treatment. Researchers used this information to find the number of participants with a decrease in tumor size or complete disappearance of all signs of cancer in the body.
This is also known as the objective response rate.
Researchers also assessed the number of participants whose cancer did not worsen. This is also known as the disease control rate.
Objective response rate = 4% (1)
Disease control rate = 11% (3)
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F19741%252F%2FNBTI%2FFE_1AQ%2FAQ%2Ff2a11705-b5df-440f-9de8-03a62bfecf77%2F1%2FI4GuMsVc-z&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C7143b4528c5c461d955808dc73fc05dc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638512773467864512%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=nwscac4Yhz4PvIdDGIPIhlAfcpzpz2vu2ra%2BvsK%2BObA%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: Information about Bayer clinical trials being conducted and their results will be available on the website
https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bayer.com%2F&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C7143b4528c5c461d955808dc73fc05dc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638512773467877148%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=yPRbkh3ZabXMozOzRzGm%2FOjk7mUo4eY3jdfWe%2Bn2994%3D&reserved=0 (click on clinical trials). All study results may be published in relevant peer reviews journals and thereby made available to the general public.If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Information about Bayer clinical trials being conducted and their results will be available on the website
https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bayer.com%2F&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C7143b4528c5c461d955808dc73fc05dc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638512773467885898%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=foPQJWdkr1U1lITQMohN1QQh2XyIEL7keVAah9vttOQ%3D&reserved=0 (click on clinical trials). All study results may be published in relevant peer reviews journals and thereby made available to the general public.REC name
London - Central Research Ethics Committee
REC reference
20/LO/0947
Date of REC Opinion
30 Sep 2020
REC opinion
Further Information Favourable Opinion