CDAK539A12103- Phase 1b, Open-Label Study of Pelabresib
Research type
Research Study
Full title
A Phase 1b, Open-Label, Multicenter Study to Evaluate the Pharmacokinetic Profile of Pelabresib (DAK539/CPI-0610) in Patients with Advanced Malignancies and Hepatic Impairment
IRAS ID
1013282
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Research summary
The purpose of this trial is to assess the safety of the trial drug pelabresib and how the body processes it in people with advanced malignancies who have either liver impairment (HI) or normal liver function. Pelabresib is a trial drug that works by blocking a group of proteins called BET proteins. These proteins help cancer cells grow. By blocking these proteins, pelabresib can slow down or stop the growth of cancer cells.
This trial will be conducted in two parts: Part 1 and Part 2. In Part 1, participants will be divided into two groups based on liver function - Group 1 with normal liver function and Group 2 with impaired liver function. In both parts, the participants will take pelabresib in cycles of 21 days, once daily treatment for the first 14 days followed by no treatment for 7 days. In Part 2, those who seem to benefit from the treatment will continue taking pelabresib.
To learn the impact of liver function on pelabresib, researchers will measure the pharmacokinetic (PK) profile of pelabresib after a single and multiple doses to participants. Liver impairment is a condition where the liver is not functioning properly. Because the liver helps to process and remove certain drugs from the body, liver damage can change how the body processes drugs like pelabresib.About 24 participants, about 12 participants in each group, will take part in this trial.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0275
Date of REC Opinion
21 Jan 2026
REC opinion
Further Information Favourable Opinion