Phase 1 study of EXS73565 in participants with relapsed or refractoryB-cell malignancies
Research type
Research Study
Full title
A Phase 1 open-label, multicenter, dose escalation study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of EXS73565 in participants with relapsed or refractory B-cell malignancies
IRAS ID
1010761
Contact name
Michael Kurman
Contact email
Sponsor organisation
Exscientia AI Ltd
Clinicaltrials.gov Identifier
Research summary
This is the first time EXS73565 will be given to people. There will be one part to this study: Dose escalation of EXS73565. The purpose of this study is to test the safety of study drug at different dose levels, to look at side effects, to understand what the body does to the study treatment and to estimate the optimum dose when administered daily as an oral tablet.
EXS73565 is a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor. The MALT1 is a protein found in lymphocytes which controls the B-cell lymphocyte survival and activity. Based on research in animals and cell lines, it is expected that EXS73565 will inhibit this protein in order to slow B-cell cancer cells or stop them growing and could potentially help in the treatment of advanced B-cell malignancies. EXS73565 could also help standard of care treatments work when given together. There are currently no MALT-1 inhibitors approved for human use.
Approximately 50 participants diagnosed with B-cell malignancies, who may not have responded to or have stopped responding to currently available treatments, will be enrolled into this study.
There will be up to 31 visits at the study site. The treatment period is divided into 21-day cycles and the maximum treatment duration is 9 months (12 cycles). The study drug will be taken orally every day.
After the End of Treatment visit and 30-day safety follow-up visit, study participants will be followed until disease progression or 6 months whichever occurs first.
There will be a number of assessments (such as medical history, physical exams, vital signs, ECGs, blood/urine/tissue samples, CT/PET-CT scan) to be completed at visits.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0772
Date of REC Opinion
13 Nov 2024
REC opinion
Further Information Favourable Opinion