This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.
This study is to determine the safety of ceralasertib when given as monotherapy (discontinued) and in combination with acalabrutinib in subjects with R/R CLL and in subjects who have few therapeutic options available to them. As such, this study includes a formal DLT assessment of the first 6-12 subjects dosed in Part 1 of the study. In addition, routine and regular safety monitoring will be undertaken during this study to fully assess safety of ceralasertib given as monotherapy and in combination with acalabrutinib, with toxicity assessment and dose reduction guidelines.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
An ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).
An experimental anti-cancer drug and Bruton's tyrosine kinase (BTK) inhibitor.
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Birmingham, United Kingdom
Research Site
Bournemouth, United Kingdom
Number of participants experiencing dose-limiting toxicities
Arm A (discontinued): When given as monotherapy in subjects with R/R high-risk CLL who have exhausted other therapeutic options according to local/regional standard of care. Arm B: Ceralasertib given in combination with acalabrutinib in subjects with R/R high-risk CLL who are suitable for treatment with a BTK inhibitor and ceralasertib, per investigator's clinical opinion.
Time frame: 28 Days
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Research Site
Cardiff, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Oxford, United Kingdom
...and 1 more locations