DSB2455-001
Research type
Research Study
Full title
Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Trial with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy or in Combination with Anti-Cancer Agents in Participants with Advanced Malignancies
IRAS ID
1009288
Contact name
Donal Landers
Contact email
Sponsor organisation
Duke Street Bio Ltd.
Research summary
DSB2455-001 is a “First Time in Human” clinical study using the study medication DSB2455. DSB2455 is a selective inhibitor of poly-ADP ribose polymerase-1 (PARP1), which at an enzyme present within cells that helps to deal with DNA damage repair (DDR). The trial will be conducted initially in a small number of clinical sites in the UK and Spain, and later will include sites in America. The trial is split into two parts: in Part 1a, DSB2455 will be given to small groups, each with 2 participants with advanced cancers (prostate cancer, ovarian cancer or breast cancer). The study medication is in the form of an oral capsule or multiple capsules, which should be taken by mouth once daily for the duration of the study.
The study will start with a very low dose of DSB2455 and gradually increase to higher doses. A “safety review committee” comprising of several doctors will review the safety information from a particular dose level, before moving to the next higher dose. The effectiveness of the study medicine will also be assessed at each dose level. Once a dose is reached that appears to be safe and well tolerated, and has shown a degree of efficacy, part 1b of the study will begin, where larger groups of participants are given a fixed dose of the study medication, once daily until either their disease progresses, or one of the other stopping criteria for the study are met. The patients in part 1b of the study will be grouped in accordance to which type of cancer they have; breast cancer, prostate cancer, ovarian cancer, or cancer from another part of the body which has moved to the brain (metastatic brain cancer). At the end of the study, the results will be summarized in a Clinical Study Report (CSR).REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0137
Date of REC Opinion
15 Aug 2024
REC opinion
Further Information Unfavourable Opinion