Relapsed/Refractory (R/R) Hematologic MalignanciesPhase 1NCT07923071
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
A Phase 1 study testing Revumenib in people with Relapsed/Refractory (R/R) Hematologic Malignancies and Acute Leukemia, run by Syndax Pharmaceuticals.
Trial summary
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney impairment or normal liver and kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia, Refractory Leukemia
- What is being tested?
- Revumenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jan 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented active diagnosis of R/R hematologic malignancy (for example, R/R acute leukemias [acute myeloblastic leukemia [AML]/acute lymphoblastic leukemia [ALL] or mixed phenotype acute leukemia [MPAL]) in medically stable individuals based on their medical history and clinical evaluation who may benefit from revumenib as determined by the Investigator.
- Hepatic and renal function as indicated by clinical chemistry values.
- Adequate cardiac function defined as ejection fraction ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
- Potassium maintained at ≥4.0 milliequivalent/liter (mEq/L) and magnesium at ≥2.0 milligram/deciliter (mg/dL).
- White blood cell (WBC) must be < 25,000/microliter (µL) prior to the first dose of revumenib.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2 at Screening. (For participants ≥65 years of age, an ECOG PS score of 0 or 1.)
Who cannot join
- Gastrointestinal Disease (GI) within previous 6 months.
- Uncontrolled active infection of any type. Infections under control with antibiotic treatment are acceptable for study entry.
- Uncontrolled invasive fungal infection (positive blood or tissue culture).
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 millisecond (ms) (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Participants requiring the concurrent use of medications known or suspected to prolong the QT/QTc interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Relapsed/Refractory Hematologic Malignancies and Severe Hepatic or Renal Impairment or Normal Hepatic and Renal Function
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney impairment or normal liver and kidney function.
- Conditions
- Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia, Refractory Leukemia, Relapsed Leukemia
- Being tested
- Revumenib
- Keywords
- Renal Impairment, Hepatic Impairment, Neoplasms by Histologic Type Leukemia, Neoplasms, Hematologic Diseases, Hemic and Lymphatic Diseases, revumenib, SNDX-5613, Mixed Phenotype Acute Leukemia, Pharmacokinetics, Menin Inhibitor, Acute Lymphoblastic Leukemia, Organ Impairment, Acute Myeloid Leukemia
- Medical subject headings
- Recurrence, Hematologic Neoplasms, Leukemia, Renal Insufficiency, Neoplasms, Hematologic Diseases, Hemic and Lymphatic Diseases, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevumenibDrug
Also called SNDX-5613
Administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Severe Hepatic Impairment | Experimental | PK evaluation Period: Participants will receive a single Reduced Dose A of revumenib on Day 1.
Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2.
Participants who start the Optional Treatment Period will receive revumenib twice daily (Q12h), which may be continued for up to 2 years. Receives: Drug: Revumenib |
| Group B: Severe Renal Impairment | Experimental | PK evaluation Period: Participants will receive a single Reduced Dose B of revumenib on Day 1.
Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2.
Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years. Receives: Drug: Revumenib |
| Group C: Normal Hepatic and Renal Function | Experimental | PK evaluation Period: Participants will receive a single Recommended Dose of revumenib on Day 1.
Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2.
Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years. Receives: Drug: Revumenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of Revumenib
Measured: Up to 1 day postdose
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of M1
Measured: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of Revumenib
Measured: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of M1
Measured: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of Revumenib
Measured: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of M1
Measured: Up to 1 day postdose
Secondary outcomes (1)
Number of Participants With Adverse Events
Measured: Up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory (R/R) Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Syndax Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923071
- Sponsor's protocol ID
- SNDX-5613-0712
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Relapsed/Refractory Hematologic Malignancies and Severe Hepatic or Renal Impairment or Normal Hepatic and Renal Function
- ClinicalTrials.gov ID
- NCT07923071
- Acronym / sponsor ID
- SNDX-5613-0712
- Conditions
- Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia, Refractory Leukemia, Relapsed Leukemia
- Keywords
- Renal Impairment, Hepatic Impairment, Neoplasms by Histologic Type Leukemia, Neoplasms, Hematologic Diseases, Hemic and Lymphatic Diseases, revumenib, SNDX-5613
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney impairment or normal liver and kidney function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Severe Hepatic Impairment | Experimental | Drug: RevumenibPK evaluation Period: Participants will receive a single Reduced Dose A of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily (Q12h), which may be continued for up to 2 years. |
| Group B: Severe Renal Impairment | Experimental | Drug: RevumenibPK evaluation Period: Participants will receive a single Reduced Dose B of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years. |
| Group C: Normal Hepatic and Renal Function | Experimental | Drug: RevumenibPK evaluation Period: Participants will receive a single Recommended Dose of revumenib on Day 1. Optional Treatment Period: If the Investigator believes it is in the best clinical interest of the participant, the participant may start the Optional Treatment Period immediately after completing the PK Evaluation Period on Study Day 2. Participants who start the Optional Treatment Period will receive revumenib twice daily, which may be continued for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented active diagnosis of R/R hematologic malignancy (for example, R/R acute leukemias [acute myeloblastic leukemia [AML]/acute lymphoblastic leukemia [ALL] or mixed phenotype acute leukemia [MPAL]) in medically stable individuals based on their medical history and clinical evaluation who may benefit from revumenib as determined by the Investigator.
- Hepatic and renal function as indicated by clinical chemistry values.
- Adequate cardiac function defined as ejection fraction ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
- Potassium maintained at ≥4.0 milliequivalent/liter (mEq/L) and magnesium at ≥2.0 milligram/deciliter (mg/dL).
- White blood cell (WBC) must be < 25,000/microliter (µL) prior to the first dose of revumenib.
Key exclusion criteria (7 listed)
- Gastrointestinal Disease (GI) within previous 6 months.
- Uncontrolled active infection of any type. Infections under control with antibiotic treatment are acceptable for study entry.
- Uncontrolled invasive fungal infection (positive blood or tissue culture).
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 millisecond (ms) (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevumenibAlso: SNDX-5613Administered as oral tablets. | Drug | Group A: Severe Hepatic Impairment, Group B: Severe Renal Impairment, Group C: Normal Hepatic and Renal Function |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of Revumenib
Time frame: Up to 1 day postdose
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of M1
Time frame: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of Revumenib
Time frame: Up to 1 day postdose
Maximum Observed Concentration (Cmax) of M1
Time frame: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of Revumenib
Time frame: Up to 1 day postdose
Terminal Elimination Half-Life (t1/2) of M1
Time frame: Up to 1 day postdose
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Up to 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Syndax Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Revumenib in people with Relapsed/Refractory (R/R) Hematologic Malignancies and Acute Leukemia, run by Syndax Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syndax Pharmaceuticals (781-419-1400, clinicaltrials@syndax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of Revumenib (time frame: Up to 1 day postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.