A Phase 1/2 interventional study of Revumenib and Chemotherapy in Colorectal Cancer and Solid Tumors, sponsored by Syndax Pharmaceuticals. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Syndax Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 41 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Syndax Pharmaceuticals is the lead sponsor of 29 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: Revumenib
Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
Drug: Revumenib
Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
Drug: Revumenib
Participants will receive chemotherapy from Day 1 of each 28-day cycle.
Drug: Chemotherapy
Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
Also known as: SNDX-5613
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2.2 years
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2.2 years
| Milestone | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| Started | 3 | 10 | 6 | 22 |
| Received at least 1 dose of study drug | 3 | 10 | 6 | 22 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 3 | 10 | 6 | 22 |
| Withdrew: Death | 3 | 8 | 5 | 15 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 1 | 1 | 7 |
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.
| Participants | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule |
|---|---|---|---|
| Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 | 0 | 0 |
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.
| Participants | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 3 | 8 | 6 | 22 |
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.
| percentage of participants | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| Phase 1: Disease Control Rate (DCR) | 0 (0.0 to 70.8) | 25.0 (3.2 to 65.1) | 33.3 (4.3 to 77.7) | 10.0 (1.2 to 31.7) |
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.
| percentage of participants | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| Phase 1: Overall Response Rate (ORR) | 0 (0.0 to 70.8) | 0 (0.0 to 36.9) | 0 (0.0 to 45.9) | 0 (0.0 to 16.8) |
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.
No measurements were reported for this outcome.
| nanograms per milliliter (ng/mL) | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule |
|---|---|---|---|
| Cycle 1 Day 7 | 2525 ± 26.2 | 3092 ± 69.4 | 4078 ± 43.2 |
| Cycle 1 Day 14 | 2174 ± 24.5 | 2312 ± 73.0 | 3286 ± 44.4 |
| Cycle 2 Day 8 | 3786 ± 9.9 | 3436 ± 52.2 | 2762 ± 99.1 |
| Cycle 2 Day 15 | 2983 ± 10.0 | 3178 ± 86.6 | 4404 ± 65.7 |
| Cycle 5 Day 1 | — | 1190 | 3940 |
| ng/mL | Phase 1b: Revumenib 270 mg Tablet |
|---|---|
| Cycle 1 Day 7 | 3225 ± 58.6 |
| Cycle 1 Day 14 | 3014 ± 56.6 |
| Cycle 2 Day 8 | 3952 ± 56.3 |
| Cycle 2 Day 15 | 2237 ± 66.7 |
| hours*nanograms/milliliter | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule |
|---|---|---|---|
| Cycle 1 Day 7 | 12210 ± 25.1 | 14600 ± 53.4 | 17010 ± 37.4 |
| Cycle 1 Day 14 | 9202 ± 21.8 | 11580 ± 77.4 | 16200 ± 48.3 |
| Cycle 2 Day 8 | 14220 ± 3.9 | 16520 ± 61.0 | 13900 ± 91.2 |
| Cycle 2 Day 15 | 11700 ± 0.7 | 14840 ± 90.4 | 19580 ± 58.6 |
| Cycle 5 Day 1 | — | 6904 | 22640 |
| hours | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule |
|---|---|---|---|
| Cycle 1 Day 7 | 2.117 (2.03 to 4.00) | 1.033 (0.483 to 2.02) | 0.9333 (0.467 to 0.967) |
| Cycle 1 Day 14 | 2.050 (2.03 to 2.07) | 2.017 (1.95 to 3.80) | 2.050 (1.83 to 3.85) |
| Cycle 2 Day 8 | 1.242 (0.500 to 1.98) | 0.9333 (0.433 to 1.92) | 0.9833 (0.00 to 2.08) |
| Cycle 2 Day 15 | 1.242 (0.500 to 1.98) | 0.9667 (0.933 to 1.92) | 1.000 (0.450 to 3.85) |
| Cycle 5 Day 1 | — | 4.000 (4.00 to 4.00) | 3.78 (3.78 to 3.78) |
| hours | Phase 1b: Revumenib 270 mg Tablet |
|---|---|
| Cycle 1 Day 7 | 1.967 (0.500 to 5.75) |
| Cycle 1 Day 14 | 2.150 (1.92 to 4.12) |
| Cycle 2 Day 8 | 1.008 (0.500 to 2.00) |
| Cycle 2 Day 15 | 1.042 (0.00 to 4.03) |
| h*ng/mL | Phase 1b: Revumenib 270 mg Tablet |
|---|---|
| Cycle 1 Day 7 | 16400 ± 68.2 |
| Cycle 1 Day 14 | 16680 ± 80.6 |
| Cycle 2 Day 8 | 15610 ± 83.0 |
| Cycle 2 Day 15 | 10620 ± 114.0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
OS was defined as the time from the date of first dosing of revumenib to death due to any cause.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Up to 2.2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | 8/10 (80%) | 2/10 (20%) | 8/10 (80%) |
| Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | 5/6 (83.3%) | 2/6 (33.3%) | 6/6 (100%) |
| Phase 1b: Revumenib 270 mg Tablet | 15/22 (68.2%) | 6/22 (27.3%) | 22/22 (100%) |
| Event | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 1/3 | 0/10 | 0/6 | 2/22 |
| Procedural painInjury, poisoning and procedural complications | 1/3 | 0/10 | 0/6 | 0/22 |
| Acute kidney injuryRenal and urinary disorders | 1/3 | 0/10 | 0/6 | 0/22 |
| PyrexiaGeneral disorders | 0/3 | 0/10 | 1/6 | 0/22 |
| Urinary tract obstructionRenal and urinary disorders | 0/3 | 0/10 | 1/6 | 0/22 |
| Deep vein thrombosisVascular disorders | 0/3 | 0/10 | 1/6 | 0/22 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/10 | 0/6 | 3/22 |
| OedemaGeneral disorders | 0/3 | 1/10 | 0/6 | 0/22 |
| Atrial fibrillationCardiac disorders | 0/3 | 1/10 | 0/6 | 0/22 |
| Large intestinal obstructionGastrointestinal disorders | 0/3 | 0/10 | 0/6 | 1/22 |
| Event | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 2/3 | 1/10 | 5/6 | 10/22 |
| VomitingGastrointestinal disorders | 0/3 | 2/10 | 4/6 | 8/22 |
| FatigueGeneral disorders | 1/3 | 1/10 | 3/6 | 5/22 |
| Electrocardiogram QT prolongedInvestigations | 0/3 | 2/10 | 0/6 | 9/22 |
| DysgeusiaNervous system disorders | 0/3 | 4/10 | 2/6 | 5/22 |
| Abdominal distensionGastrointestinal disorders | 1/3 | 1/10 | 1/6 | 5/22 |
| ConstipationGastrointestinal disorders | 1/3 | 1/10 | 0/6 | 4/22 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 1/10 | 2/6 | 3/22 |
| Abdominal painGastrointestinal disorders | 1/3 | 0/10 | 0/6 | 3/22 |
| Abdominal pain upperGastrointestinal disorders | 1/3 | 0/10 | 0/6 | 1/22 |
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study.
| Age, Continuous(years) | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet | Total |
|---|---|---|---|---|---|
| Mean | 62.3 ± 9.87 | 57.9 ± 10.37 | 56.5 ± 15.10 | 57.1 ± 14.31 | 57.6 ± 12.92 |
| Sex: Female, Male(Participants) | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet | Total |
|---|---|---|---|---|---|
| Female | 1 | 4 | 3 | 10 | 18 |
| Male | 2 | 6 | 3 | 12 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 3 | 3 |
| Not Hispanic or Latino | 3 | 10 | 5 | 17 | 35 |
| Unknown or Not Reported | 0 | 0 | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule | Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule | Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule | Phase 1b: Revumenib 270 mg Tablet | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 3 | 9 | 3 | 19 | 34 |
| More than one race | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Syndax Pharmaceuticals