Clinical trial · Interventional
A Study to Evaluate the Safety and Preliminary Efficacy of a Response-guided Dose Titration of KER-047 in the Treatment of Functional IDA (Iron Deficiency Anemia).
A Phase 2, Intrapatient Dose Titration Study of KER-047 in Participants With Functional Iron Deficiency Anemia Associated With Myelodysplastic Syndromes, Myelofibrosis, and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Iron Deficiency Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KER-047 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 (Initial Titration Strategy)
- description
- KER-047(30 mg, 60mg or 80mg) oral tablet daily (or every other day) for up to 24 weeks.
- interventionNames
- Drug: KER-047
- type
- EXPERIMENTAL
- label
- Part 2 (Cohort Expansion or Alternate Titration Strategy)
- description
- The starting dose regimen and titration schedule of KER-047 oral tablet will be based on the SRC (Safety Review Committee) recommendation from Part 1.
- interventionNames
- Drug: KER-047
Primary outcomes (15)
- measure
- Percentage of participants experiencing Treatment-emergent adverse events (TEAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥18 years of age, at the time of signing informed consent. * One of the following: 1. Diagnosis of MDS according to the 2016 World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease with bone marrow blast percentage \<5% within 6 months prior to Day 1 (D1). 2. Diagnosis of primary myelofibrosis, post polycythemia vera MF, or post-essential thrombocytopenia MF according to the 2017 WHO criteria with bone marrow and peripheral blood blast percentage \<2%, or stable between 2% to 5% over 6 months. 3. Diagnosis of MDS/MPN overlap syndromes according to the 2016 WHO classification, with bone marrow blast percentage \<5% within 6 months prior to D1. * Anemia with iron-restricted erythropoiesis as assessed by laboratory criteria during screening. * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations. * Females of childbearing potential and sexually active males must meet the contraception requirements as outlined in the protocol. Exclusion Criteria: * Active infection within 14 days of D1. * IPSS-R score indicating high or very high risk MDS, accelerated myelofibrosis (defined as \>10% blasts), or diagnosis of acute leukemia. * Diagnosis of hemolytic anemia. * Diagnosis of porphyria. * Anemia due to blood loss 28 days prior to D1. * Diagnosis of thalassemia, thalassemia trait, or other hemoglobinopathy. * History of drug or alcohol abuse, as defined by the Investigator, within the past 2 years. * History of stroke, arterial embolism, or deep venous thrombosis within 6 months prior to D1. * Known positive for human immunodeficiency virus, active infectious hepatitis B virus or active infectious hepatitis C virus.
References
Publications (0)
Data not yet available