Clinical trial · Interventional
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia
NCT05406817CI-TRIAL-00084535completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 (\[14C\])-revumenib in participants with acute leukemia.
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 |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Revumenib | Drug | Revumenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Revumenib
- description
- Participants will be administered a single dose of revumenib (containing \~100 microcuries \[14C\]-revumenib) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.
- interventionNames
- Drug: Revumenib
Primary outcomes (6)
- measure
- Percentage of Dose Excreted in Urine (feu)
- timeFrame
- Up to Day 11
- measure
- Percentage of Dose Excreted in Feces (fef)
- timeFrame
- Up to Day 11
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Males and females (of non-childbearing potential) aged ≥18 years * Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease. * Previously received standard of care therapy * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Adequate liver and cardiac function * Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose Key Exclusion Criteria: * Active diagnosis of acute promyelocytic leukemia * White blood cell (WBC) count \>25,000/microliters at time of enrollment. * Detectable human immunodeficiency virus viral load within the previous 6 months * Hepatitis B or Hepatitis C * Cardiac, gastrointestinal, or graft-versus-host disease (GVHD) * History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate * Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers * Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction * Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib * Any concurrent systemic treatment to prevent GVHD
References
Publications (0)
Data not yet available
No reference posted for this study.