Stopped: Despite several attempts to recruit eligible participants and major protocol amendments to increase the recruitment rate, recruitment challenges remained. Therefore, the Sponsor has made the decision to terminate the KER047-IR-202 Study globally.
This study aims to explore the safety and preliminary efficacy of a response-guided dose titration of KER-047 in the treatment of functional IDA (Iron deficiency anemia) in MDS (Myelodysplastic syndrome), MF(Myelofibrosis), and MDS/MPN (Myeloproliferative neoplasm) overlap syndromes.
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Percentage of participants experiencing Treatment-emergent adverse events (TEAEs)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Dose limiting toxicities (DLTs)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Percentage of participants experiencing Treatment-related AEs (Adverse events)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Number of participants discontinuing due to AEs (Adverse events)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from Baseline in clinical laboratory values
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Systolic Blood Pressure
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Diastolic Blood Pressure
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Respiratory rate
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Heart rate
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body temperature
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Fridericia corrected QT interval via 12-lead Electrocardiogram (ECG)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
QT interval via 12-lead Electrocardiogram (ECG)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
QRS interval via 12-lead Electrocardiogram (ECG)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
PR interval via 12-lead Electrocardiogram (ECG)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body weight (in kg)
Timeframe: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension