KER-050 as Monotherapy or in Combination with Ruxolitinib in Participants with Myelofibrosis
Research type
Research Study
Full title
A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination with Ruxolitinib in Participants with Myelofibrosis
IRAS ID
1004080
Contact name
Donal McLornan
Contact email
Sponsor organisation
Keros Therapeutics, Inc.
Eudract number
2021-003227-15
Clinicaltrials.gov Identifier
Research summary
KER-050 is being developed by Keros Therapeutics as a potential treatment for anaemia in people with blood conditions called primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis. Myelofibrosis is a rare blood cancer in which bone marrow, a soft tissue found inside some of the bones that helps to make blood cells, is replaced by a fibrous (scar) tissue. This prevents the bone marrow from making normal, healthy blood cells and can lead to anaemia. Anaemia is when you lack enough healthy red blood cells to carry oxygen throughout your body. This study has two parts : a Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 (Dose Escalation) has two arms in which participants receive KER-050 monotherapy (Arm 1A) or KER-050 in combination with ruxolitinib (Arm 1B). Part 2 (Dose Expansion) has two arms in which participants receive KER-050 monotherapy (Arm 2A) or KER-050 in combination with ruxolitinib (Arm 2B). The expansion dose levels of KER-050 may be different for Arm 2A compared to Arm 2B and are determined by the Safety Review Committee based on the assessments in Part 1.
The study will also look at the following:
• if the study drug works (called efficacy)
• the amount of the study drug in the blood (called pharmacokinetics)
• what the study drug does to the body (called pharmacodynamics).
The therapeutic goal of this program is to develop KER-050 as either monotherapy or in combination with JAK inhibitors to treat the underlying pathology in myelofibrosis. Ruxolitinib will be administered orally. KER050 will be administered as a sub-cutaneous injection. The total duration of participation for an individual participant is approximately 64 weeks. Approximately 110 patients are planned to be enrolled from 30 sites across 7 countries. Patients will undergo physical exams, vital signs, blood/ urine sampling, heart examinations and other assessments.REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0232
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion