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Clinical trials
catalyst calendar across sponsors →Studies where SNDX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
29 interventional · 1 expanded access · 12 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 MutationNCT07211958Event Free SurvivalRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Revumenib, Placebo, Intensive Chemotherapy Regimen | Acute Myeloid Leukemias | 468 | Jun 2029 | ≤ 1,045 d | 2026-07-23 |
| A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 MutationNCT04065399Number of participants with dose-limiting toxicities (DLTs) (Phase 1)Open-label · Treatment | Phase 1/2 | Recruiting | Drug: revumenib, cobicistat | Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage | 447 | 2027-12-15 | in 482 d | 2026-03-18 |
| A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid LeukemiasNCT06226571Dose Escalation: Number of Participants with Dose-limiting ToxicitiesOpen-label · Treatment | Phase 1 | Active, not recruiting | Drug: SNDX-5613, Chemotherapy Regimen, HiDAC | Acute Myeloid Leukemias | 76 | Feb 2027 | ≤ 192 d | 2026-06-30 |
| MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)NCT06132256Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])Randomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: Axatilimab · Other: Placebo | Idiopathic Pulmonary Fibrosis | 145 | Sep 2026 | ≤ 41 d | 2026-03-27 |
| A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)NCT04710576results2024-10-10Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Recruiting | Drug: Axatilimab | Chronic Graft-versus-host-disease | 296 | 2023-04-07actual | — | 2026-06-16 |
| Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid TumorsNCT05731947results2026-07-06Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. | Drug: Revumenib, Chemotherapy | Colorectal Cancer, Solid Tumors | 41 | 2025-06-30actual | — | 2026-07-06 |
| Study of Radiolabeled Revumenib in Adults With Acute LeukemiaNCT05406817Percentage of Dose Excreted in Urine (feu)Open-label · Treatment | Phase 1 | Completed | Drug: Revumenib | Acute Leukemia | 9 | 2024-11-18actual | — | 2025-01-10 |
| A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute LeukemiaNCT05326516Number of Participants With Dose Limiting Toxicities From RevumenibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Revumenib, Chemotherapy Regimen 1, Chemotherapy Regimen 2 | Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Mixed Phenotype Acute Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia | 30 | 2024-07-29actual | — | 2024-08-13 |
| Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)NCT02437136results2025-03-20Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: entinostat, pembrolizumab | Non-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal Cancer | 191 | 2022-09-29actual | — | 2025-03-20 |
| A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHDNCT03604692results2024-11-27Phase 1: Number of Participants With DLTsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: axatilimab | Chronic Graft-versus-host-disease | 41 | 2022-08-12actual | — | 2025-09-15 |
| Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead InNCT02708680results2023-09-14Phase 1b: Participants Experiencing DLTRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Entinostat, Atezolizumab, Placebo | Breast Cancer | 89 | 2021-03-31actual | — | 2024-12-04 |
| A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid TumorsNCT03238027Phase 1a: Determination of any Dose limiting toxicities (DLT)s of AxatilimabNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Axatilimab, Durvalumab | Solid Tumor, Metastatic Tumor, Locally Advanced Malignant Neoplasm, Unresectable Malignant Neoplasm | 45 | 2020-11-20actual | — | 2024-05-17 |
| A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19NCT04415073results2022-07-22Count Of Participants Alive And Free Of Respiratory Failure At Day 29Randomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape, the trial has been closed. | Drug: SNDX-6352, Placebo | Coronavirus, COVID, ARDS, Cytokine Storm, Cytokine Release Syndrome | 1 | 2020-07-13actual | — | 2022-07-22 |
| Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid TumorsNCT02909452Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) resulting in the permanent discontinuation of study drug, and deaths occurring within the reporting period required for the studyRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Entinostat, Pembrolizumab | Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Breast Diseases, Renal Neoplasm, Solid Tumors | 30 | 2019-07-17actual | — | 2022-01-25 |
| Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian CancerNCT02915523results2024-01-10Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: entinostat, avelumab, Placebo | Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer | 140 | 2019-02-21actual | — | 2024-01-10 |
| Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast CancerNCT02820961Cmax, maximum plasma concentrationNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: entinostat, exemestane | Breast Cancer, Estrogen Receptor Positive Breast Cancer | 61 | 2018-09-10actual | — | 2021-12-15 |
| A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal FunctionNCT03192111To evaluate AUC0-t (area under the concentration-time curve) for entinostat in subjects with varying degrees of renal impairment versus healthy matched subjects.Non-randomized · Open-label · Other | Phase 1 | Completed | Drug: Entinostat | Renal Impairment, Healthy Volunteer | 40 | 2017-11-23actual | — | 2018-04-13 |
| A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult SubjectsNCT03187015PK endpoint of AUC0-t (area under the concentration-time curve) for midazolam administered with and without entinostat.Open-label · Other | Phase 1 | Completed | Drug: Entinostat, Midazolam | Drug Interaction, Healthy Volunteer | 26 | 2017-06-04actual | — | 2018-08-16 |
| Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of EntinostatNCT02922946AUC0-t (area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) for entinostat under fed and fasting conditionsRandomized · Open-label · Other | Phase 1 | Completed | Drug: Entinostat | Volunteers, Healthy Volunteers, Human Volunteers, Normal Volunteers | 47 | 2017-05-20actual | — | 2018-08-16 |
| A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult SubjectsNCT02922933AUC0-t (area under the concentration-time curve) for entinostat administered with or without omeprazole (Part 1), with or without famotidine (Part 2), or omeprazole with and without acidic beverageNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: entinostat · Dietary supplement: Omeprazole, Famotidine | Volunteers, Healthy Volunteers, Human Volunteers, Normal Volunteers | 66 | 2017-04-19actual | — | 2018-08-16 |
| Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid TumorsNCT02897778Change from Baseline in Heart Rate (HR)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Entinostat, Placebo | Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Breast Neoplasms, Breast Diseases, Renal Neoplasm, Solid Tumors | 30 | 2017-03-13actual | — | 2022-04-28 |
| Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast CancerNCT02115594Progression Free SurvivalRandomized · Triple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Internal decision | Drug: Fulvestrant, Entinostat, Placebo | Breast Cancer | 0 | Dec 2015 | — | 2014-10-08 |
| Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung CancerNCT01594398Difference in pharmacokinetics of entinostat when subjects fed or fastedRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: entinostat, entinostat, Erlotinib, Erlotinib, Exemestane, Exemestane | Lung Cancer, Non Small Cell Lung Cancer (NSCLC), Breast Cancer, Estrogen Receptor Breast Cancer | 14 | Apr 2014actual | — | 2021-11-19 |
| A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's LymphomaNCT00866333results2019-10-22Percentage of Participants With Best Overall Response Based on the Participant's Best Response That is Documented Within the First 6 Cycles of Protocol TherapyOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Terminated prior to completion of accrual per corporate decision. | Drug: Entinostat | Hodgkin's Lymphoma | 49 | 2013-02-08actual | — | 2019-10-22 |
| Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast CancerNCT00676663results2019-10-24Progression-free Survival (PFS)Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: entinostat, exemestane, Placebo | Breast Cancer, Estrogen Receptor-Positive Breast Cancer, Breast Cancer, Estrogen Receptor-Positive, ER+ Breast Cancer | 130 | 2011-01-29actual | — | 2022-05-11 |
| A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on ErlotinibNCT00750698results2023-07-06Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 MonthsNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Due to business reasons, enrollment on the study was halted and the study terminated. The decision to close enrollment was not due to any safety concern. | Drug: Entinostat, Erlotinib | Non Small Cell Lung Cancer | 8 | May 2010actual | — | 2023-07-06 |
| Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLCNCT00602030results2022-06-28Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in PhaseRandomized · Triple-masked · Treatment | Phase 1/2 | Completed | Drug: Entinostat, Placebo, Erlotinib | Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung | 141 | 2010-02-04actual | — | 2022-08-22 |
| Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is ProgressingNCT00828854results2022-06-30Clinical Benefit Rate (CBR)Open-label · Treatment | Phase 2 | Completed | Drug: Entinostat, Aromatase Inhibitor (AI) Therapy | ER+ Breast Cancer | 27 | 2009-11-24actual | — | 2022-06-30 |
| A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast CancerNCT00754312Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administrationNon-randomized · Open-label · Other | Phase 1 | Terminated | Drug: SNDX-275 | Breast Cancer | 1 | 2009-02-28actual | — | 2022-06-06 |
| Expanded Access Program for RevumenibNCT05918913expanded access | — | No longer available | Drug: Revumenib | Relapsed/Refractory Acute Leukemia | — | — | — | 2025-09-05 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19