Elimusertib in combination with cisplatin or irinotecan for advanced cancers
Research type
Research Study
Full title
ATR inhibitor elimusertib (BAY 1895344) in combination with cisplatin or irinotecan in participants with advanced solid tumors
IRAS ID
1004471
Contact name
Stuart Lavin
Contact email
Sponsor organisation
Bayer AG
Eudract number
2021-004397-57
Research summary
Researchers want to learn more about a new substance called elimusertib (also known as BAY 1895344). Elimusertib inhibits a protein called “ATR”, and in doing so may make cancer cells more sensitive to the effects of anti-tumor agents such as chemotherapies.
In this study, elimusertib will be given together with cisplatin or irinotecan, which are types of chemotherapies. The purpose of the study will be to evaluate the safety and preliminary signs of anti-tumor activity of elimusertib administered with either cisplatin or irinotecan.
Participants will take elimusertib as tablets by mouth and will receive cisplatin or irinotecan through a needle placed into a vein (also known as an intravenous [IV] infusion).
This study will have 2 parts. Depending on their cancer, each participant in the first part will be assigned to receive either elimusertib with cisplatin or elimusertib with irinotecan. In this part of the study, groups of participants will be administered specified doses of study treatments. Depending on safety findings, the next group of participants may receive either a higher or lower dose of study treatments. Participants in the second part will receive the most appropriate doses that were identified in the first part.
During the study, participants will receive their treatments in 3-week periods called “cycles”. Participants will take elimusertib on between 4 and 6 days each cycle and will receive either cisplatin or irinotecan 2 or 3 times each cycle. There will be between 2 and 5 scheduled clinic visits in each cycle. Participants will repeat these 3-week cycles until their cancer gets worse, they have medical problems, they leave the study, or the study ends.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0012
Date of REC Opinion
1 Mar 2022
REC opinion
Further Information Favourable Opinion