Clinical trial · Interventional
A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 With and Without ATRA (Tretinoin) in Patients With Advanced Myeloid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known as tretinoin and Vesanoid®) in combination with bomedemstat. This study investigates the following: * The safety and tolerability of bomedemstat with and without ATRA * The pharmacodynamic effect of different doses of bomedemstat and treatment durations, as well as bomedemstat administered in combination with ATRA * The pharmacokinetics of bomedemstat with and without ATRA
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bomedemstat | Drug | — | UNRESOLVED |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Cohort 1a: bomedemstat 0.75 mg/kg/day
- description
- Participants receive bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants will receive up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).
- interventionNames
- Drug: bomedemstat
- type
- EXPERIMENTAL
- label
- Cohort 1b: bomedemstat 1.5 mg/kg/day
- description
- Participants receive bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants will receive up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).
- interventionNames
- Drug: bomedemstat
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: High-risk Acute Myeloid Leukemia (AML) * Have a diagnosis of AML according to the World Health Organization (WHO) criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 * Have AML that is classified as high risk as defined by one of the following: ≥ 60 years of age who were not candidates for or have refused standard chemotherapy; ≥18 years of age with de novo or secondary AML who were not expected to benefit from standard remission-induction chemotherapy; or had relapsed/refractory AML after no more than 3 previous lines of chemotherapy. High-risk Myelodysplastic Syndromes (MDS) * Have a diagnosis of myelodysplastic syndromes according to the World Health Organization (WHO) criteria * Have either an International Prognostic Scoring System (IPSS) score equivalent to intermediate-2 risk or higher, or a Revised International Prognostic Scoring System (IPSS-R) score equivalent to intermediate risk or higher. * Have MDS that is classified as high risk as defined by one of the following: participants who have failed first-line therapy; or treatment-related MDS, except if it is associated with favorable cytogenetics, and not a candidate for stem cell transplantation * Prior autologous stem cell transplant is allowed if a minimum of 3 months has elapsed from the time of transplant and the patient has recovered from transplant-associated toxicities * Prior allogeneic stem cell transplant is allowed, provided all of the following criteria are met: transplant was \>120 days prior to study enrollment; no immunosuppressive medications have been taken for at least 1 month; and no active graft versus host disease (GVHD), excluding Grade 1 skin GVHD * Has a life expectancy \>12 weeks Exclusion Criteria: * Is receiving other treatments for the condition (with exceptions and time limits) * Has had major surgery in last 4 weeks or minor surgery in the last 2 weeks * Has a scheduled hematopoietic stem-cell transplant * Is currently using prohibited medications * Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia * Has a concurrent second active and non-stable malignancy * Has an uncontrolled active infection * Has known Human Immunodeficiency Virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection * Has used an investigational agent within last 14 days * Is a pregnant or lactating females
References
Publications (0)
Data not yet available