MERCK - MS200662_0001
Research type
Research Study
Full title
Phase I/II, First in Human, Dose Escalation Trial of the Bruton’s Tyrosine Kinase Inhibitor M7583 in Patients with Relapsed/Refractory B Cell Malignancies and Expansion Cohorts in Patients with Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma (ABC subtype) that have Progressed after at least 1 but not more than 3 Prior Lines of Therapy
IRAS ID
150998
Contact name
William Townsend
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2016-000286-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a Phase I/II study to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies in whom at least 1 but no more than 3 prior therapies failed. Part 1 of this study is no longer enrolling participants. Part 2 of this study will test different doses of TL-895 in participants with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who are treatment naive (have not received treatment for their CLL/SLL) and in participants with R/R CLL or SLL in whom the diseases has come back after or did not respond to at least 1 prior treatment to evaluate if it is well tolerated and effective. Part 2 of this study is currently active in select countries. TL-895 is an investigational medicine. Investigational means it is not yet approved for everyday use and can only be
used in clinical trials such as this one. TL-895 is available as tablets only. Telios Pharma, Inc. (the Sponsor) is responsible for the development of TL-895 and the oversight of this study. Approximately 100 patients are expected to take part in this study at medical centres in North America and Europe, including the UK.REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/0574
Date of REC Opinion
19 Apr 2016
REC opinion
Favourable Opinion