Colorectal CancerPhase 1/2NCT05731947
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
A Phase 1/2 study testing Revumenib and Chemotherapy in people with Colorectal Cancer and Solid Tumors, run by Syndax Pharmaceuticals at 6 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors who have failed at least 1 prior line of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Solid Tumors
- What is being tested?
- Revumenib and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Apr 2023to 30 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female participants aged ≥18 years
- Participants with metastatic CRC or other solid tumors
- Evidence of locally recurrent or metastatic disease based on imaging studies within 28 days of cycle 1/day 1 (C1D1)
- CRC participants must have had at least one line of standard-of-care therapy and must have progressed on or been intolerant to, or unable to receive, oxaliplatin, irinotecan, and bevacizumab in the advanced/metastatic setting.
- Other solid tumor participants must have had all approved standard therapies that are available to the participant, unless contraindicated or intolerable.
- Participants must have experienced documented unequivocal progressive disease by either RECIST v1.1 or clinical assessment, or experienced unacceptable toxicity with their prior therapy.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- If receiving radiation therapy, has had a 2-week washout period following completion of the treatment prior to receiving the C1D1 dose and continues to have at least 1 measurable lesion
- At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T-cell therapy
- Adequate bone marrow, renal, cardiac, and liver function
Who cannot join
- Participant has a prior history of malignant bowel obstruction requiring hospitalization in the 6 months prior to enrollment
- Participant has a history of uncontrolled ascites, defined as symptomatic ascites and/or repeated paracenteses for symptom control in the past 3 months
- Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1/2 antibodies must have viral load testing prior to study enrollment
- Hepatitis B and/or C
- 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
- Corrected QT interval (QTc) >450 milliseconds
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- Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion (for example, gastric bypass, gastroparesis)
- Cirrhosis with a Child-Pugh score of B or C
- Brain metastasis except for those participants who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 4 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)
- History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that in the Investigator's opinion 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
- Participant has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study baseline or who has not recovered (that is, ≤Grade 1 or at baseline) from AEs related to a previously administered agent.
- Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib
- Participant has received a transfusion of blood products or administration of colony stimulating factors within 4 weeks of the first dose of the study drug
- History of additional malignancy within the prior 5 years, excluding adequately treated basal cell carcinoma, squamous cell of the skin, cervical intraepithelial neoplasia/cervical carcinoma in situ, or melanoma in situ or ductal carcinoma in situ of the breast
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Gabrail Cancer Center
Canton, Ohio, 44718
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Memorial Sloan Kettering Cancer Center
Manhattan, New York, 10065
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Honor Health Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors who have failed at least 1 prior line of therapy.
Read the detailed description
The study will be conducted in two parts. The Phase 1 portion of the study consists of a dose escalation cohort, and a signal-seeking expansion where anti-tumor activity signals will be evaluated. The Phase 2 portion of the study will further confirm the anti-tumor activity signals of revumenib.
- Conditions
- Colorectal Cancer, Solid Tumors
- Being tested
- Revumenib, Chemotherapy
- Keywords
- SNDX-5613, Revumenib, Menin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevumenibDrug
Also called SNDX-5613
Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
ChemotherapyDrug
Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Participants will receive revumenib tablets or capsules three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle. Receives: Drug: Revumenib |
| Phase 1b: Signal-Seeking | Experimental | Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle. Receives: Drug: Revumenib |
| Phase 2: Revumenib | Experimental | Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle. Receives: Drug: Revumenib |
| Phase 2: Chemotherapy | Active comparator | Participants will receive chemotherapy from Day 1 of each 28-day cycle. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLT was defined as any of the following occurring in Cycle 1: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) unresolved to Grade 2 (ANC >1500 cells/mm^3) or baseline for more than 7 consecutive days in the absence of growth factor support, ≥Grade 3 neutropenia (ANC <1000 cells/mm^3) with a single temperature of >38.3°Celsius (101°Fahrenheit) or a sustained temperature of ≥38°Celsius (100.4°Fahrenheit) for more than 1 hour, Grade 4 thrombocytopenia (<25,000/mm^3) of any duration, ≥Grade 3 thrombocytopenia (<50,000/mm^3) with clinically significant bleeding, Grade 4 anemia (i.e, life-threatening consequences; urgent intervention indicated) or ≥Grade 3 nonhematologic toxicity as defined in Common Terminology Criteria for Adverse Events version 5.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Measured: Day 1 up to Day 28
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention. TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to 2.2 years
Phase 1: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with objective evidence of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to Response Evaluation in Solid Tumors (RECIST) version 1.1 criteria as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Measured: Up to 2.2 years
Phase 1: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by the investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Measured: Up to 2.2 years
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from the first dosing date to the first documented progression or death due to any cause, whichever occurred first.
Measured: Up to 2.2 years
Secondary outcomes (17)
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Measured: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 2: Area Under The Concentration Time Curve of Revumenib
Measured: Up to 2.2 years
Phase 2: Maximum Plasma Concentration (Cmax) of Revumenib
Measured: Up to 2.2 years
Phase 2: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Measured: Up to 2.2 years
Phase 2: Number of Participants With TEAEs
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention. TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to 2.2 years
Phase 2: Overall Survival (OS)
OS was defined as the time from the date of first dosing of revumenib to death due to any cause.
Measured: Up to 2.2 years
Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by Blinded Radiographic Review
DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by blinded radiographic review. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Measured: Up to 2.2 years
Phase 2: ORR as Assessed by Blinded Radiographic Review
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by blinded radiographic review. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Measured: Up to 2.2 years
Phase 2: Duration of Response (DOR) as Assessed by Blinded Radiographic Review
DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by blinded radiographic review. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Measured: Up to 2.2 years
Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by the Investigator
DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by investigator. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Measured: Up to 2.2 years
Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Measured: Up to 2.2 years
Phase 2: DOR as Assessed by the Investigator
DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Measured: Up to 2.2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start4 Apr 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1a dose escalation portion of the study will employ a Rolling 6 trial design, followed by a Phase 1b signal-seeking portion, and a Phase 2 randomized (2:1) signal confirmation portion. Phase 1: Non-randomized; Phase 2: Randomized
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731947
- Sponsor's protocol ID
- SNDX-5613-0706
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2023
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT05731947
- Acronym / sponsor ID
- SNDX-5613-0706
- Conditions
- Colorectal Cancer, Solid Tumors
- Keywords
- SNDX-5613, Revumenib, Menin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors who have failed at least 1 prior line of therapy.
Detailed description
The study will be conducted in two parts. The Phase 1 portion of the study consists of a dose escalation cohort, and a signal-seeking expansion where anti-tumor activity signals will be evaluated. The Phase 2 portion of the study will further confirm the anti-tumor activity signals of revumenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase 1a dose escalation portion of the study will employ a Rolling 6 trial design, followed by a Phase 1b signal-seeking portion, and a Phase 2 randomized (2:1) signal confirmation portion. Phase 1: Non-randomized; Phase 2: Randomized
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Drug: RevumenibParticipants will receive revumenib tablets or capsules three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle. |
| Phase 1b: Signal-Seeking | Experimental | Drug: RevumenibParticipants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle. |
| Phase 2: Revumenib | Experimental | Drug: RevumenibParticipants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle. |
| Phase 2: Chemotherapy | Active comparator | Drug: ChemotherapyParticipants will receive chemotherapy from Day 1 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants aged ≥18 years
- Participants with metastatic CRC or other solid tumors
- Evidence of locally recurrent or metastatic disease based on imaging studies within 28 days of cycle 1/day 1 (C1D1)
- CRC participants must have had at least one line of standard-of-care therapy and must have progressed on or been intolerant to, or unable to receive, oxaliplatin, irinotecan, and bevacizumab in the advanced/metastatic setting.
- Other solid tumor participants must have had all approved standard therapies that are available to the participant, unless contraindicated or intolerable.
Key exclusion criteria (14 listed)
- Participant has a prior history of malignant bowel obstruction requiring hospitalization in the 6 months prior to enrollment
- Participant has a history of uncontrolled ascites, defined as symptomatic ascites and/or repeated paracenteses for symptom control in the past 3 months
- Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1/2 antibodies must have viral load testing prior to study enrollment
- Hepatitis B and/or C
- 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
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-5613Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity. | Drug | Phase 1a: Dose Escalation, Phase 1b: Signal-Seeking, Phase 2: Revumenib |
| ChemotherapyEither Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity. | Drug | Phase 2: Chemotherapy |
Primary outcome
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 28
DLT was defined as any of the following occurring in Cycle 1: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) unresolved to Grade 2 (ANC >1500 cells/mm^3) or baseline for more than 7 consecutive days in the absence of growth factor support, ≥Grade 3 neutropenia (ANC <1000 cells/mm^3) with a single temperature of >38.3°Celsius (101°Fahrenheit) or a sustained temperature of ≥38°Celsius (100.4°Fahrenheit) for more than 1 hour, Grade 4 thrombocytopenia (<25,000/mm^3) of any duration, ≥Grade 3 thrombocytopenia (<50,000/mm^3) with clinically significant bleeding, Grade 4 anemia (i.e, life-threatening consequences; urgent intervention indicated) or ≥Grade 3 nonhematologic toxicity as defined in Common Terminology Criteria for Adverse Events version 5.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2.2 years
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention. TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Phase 1: Disease Control Rate (DCR)
Time frame: Up to 2.2 years
DCR was defined as the percentage of participants with objective evidence of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to Response Evaluation in Solid Tumors (RECIST) version 1.1 criteria as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Phase 1: Overall Response Rate (ORR)
Time frame: Up to 2.2 years
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by the investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Phase 2: Progression Free Survival (PFS)
Time frame: Up to 2.2 years
PFS was defined as the time from the first dosing date to the first documented progression or death due to any cause, whichever occurred first.
17 secondary outcomes
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Time frame: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
Phase 2: Area Under The Concentration Time Curve of Revumenib
Time frame: Up to 2.2 years
Phase 2: Maximum Plasma Concentration (Cmax) of Revumenib
Time frame: Up to 2.2 years
Phase 2: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Time frame: Up to 2.2 years
Phase 2: Number of Participants With TEAEs
Time frame: Up to 2.2 years
Phase 2: Overall Survival (OS)
Time frame: Up to 2.2 years
Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by Blinded Radiographic Review
Time frame: Up to 2.2 years
Phase 2: ORR as Assessed by Blinded Radiographic Review
Time frame: Up to 2.2 years
Phase 2: Duration of Response (DOR) as Assessed by Blinded Radiographic Review
Time frame: Up to 2.2 years
Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by the Investigator
Time frame: Up to 2.2 years
Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to 2.2 years
Phase 2: DOR as Assessed by the Investigator
Time frame: Up to 2.2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Revumenib and Chemotherapy in people with Colorectal Cancer and Solid Tumors, run by Syndax Pharmaceuticals at 6 sites in United States.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 28). The study lists 5 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 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.