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Xentuzumab

(Entinostat)

Phase 3Small molecule

SSyndax Pharmaceuticals

Entinostat is being studied as a cancer treatment, particularly for certain blood cancers and solid tumors. It works by helping the immune system fight cancer cells and can make cancer cells more vulnerable to other treatments.[1] Xentuzumab is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]

Xentuzumab is one of 131 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

6

Indications

73

Total Trials

14

Active Trials

130

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerCompleted

Bladder CancerNot yet recruiting

Oropharyngeal CancerActive, not recruiting

Advanced Malignant Solid NeoplasmRecruiting

Clear Cell Renal Cell CarcinomaActive, not recruiting

RCCActive, not recruiting

Breast CancerPhase 3

Completed

Bladder CancerPhase 2

Not yet recruiting

Oropharyngeal CancerPreclinical

Active, not recruiting

Advanced Malignant Solid NeoplasmPreclinical

Recruiting

Clear Cell Renal Cell CarcinomaPreclinical

Active, not recruiting

RCCPhase 2

Active, not recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Xentuzumab

SSyndax Pharmaceuticals

Adenocard

Voltaren

Blenoxane

Bristol-Myers Squibb

Methylthioninium Chloride

PProvepharm SAS

Spravato

Tricor

Duragesic

Feraheme

AAzurity Pharmaceuticals

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Bladder Cancer

NCT03978624

Q1 2027

PreclinicalRecruiting

Breast Cancer

NCT07708194

PreclinicalActive, not recruiting

Clear Cell Renal Cell Carcinoma

NCT01038778

Phase 1Recruiting

Soft Tissue Sarcoma

NCT07888114

Q2 2027

Phase 2Active, not recruiting

Lymphoma

NCT03179930

Phase 3Active, not recruiting

Anatomic Stage III Breast Cancer AJCC V8

NCT02115282

Clinical

Trials by Indication[1]

Breast Cancer17 trials

Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07492394·60 enrolled

Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer

Withdrawn·SSyndax Pharmaceuticals·Phase 2·NCT02115594

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 Progressing

Completed·SSyndax Pharmaceuticals·Phase 2·NCT00828854·27 enrolled

Show 14 more trials

A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy

Recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT07330544·118 enrolled

Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

Unknown status·TTaizhou EOC Pharma Co., Ltd.·Phase 3·NCT03538171·375 enrolled

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01349959·58 enrolled

Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In

Completed·SSyndax Pharmaceuticals·Phase 1/2·NCT02708680·89 enrolled

Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

Completed·TTaizhou EOC Pharma Co., Ltd.·Phase 1·NCT02833155·19 enrolled

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1/2·NCT03280563·144 enrolled

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04296942·1 enrolled

Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT03291886·133 enrolled

Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

Completed·SSyndax Pharmaceuticals·Phase 2·NCT00676663·130 enrolled

A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

Completed·UUniversity of Virginia·Phase 1·NCT03473639·13 enrolled

A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment of HR+HER2- Advanced Breast Cancer

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07441486·50 enrolled

A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07235618·50 enrolled

Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01434303·37 enrolled

An Open-Label, Single-Center, Exploratory Phase Ib/II Clinical Study of Entinostat Combined With Pyrotinib Plus Endocrine Therapy in Patients With Advanced Triple-Positive Breast Cancer After Trastuzumab Failure

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Preclinical·NCT07708194·94 enrolled

Lymphoma5 trials

Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT03925428

A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma

Terminated·SSyndax Pharmaceuticals·Phase 2·NCT00866333·49 enrolled

MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00020579·75 enrolled

Show 2 more trials

MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00098891·24 enrolled

A Phase II Study of Pembrolizumab and Entinostat in Patients With Relapsed and Refractory Lymphomas

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03179930·47 enrolled

Non-Small Cell Lung Cancer5 trials

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)

Completed·SSyndax Pharmaceuticals·Phase 1/2·NCT02437136·191 enrolled

Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01207726·13 enrolled

Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00387465·94 enrolled

Show 2 more trials

Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01935947·17 enrolled

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

Completed·SSyndax Pharmaceuticals·Phase 1·NCT01594398·14 enrolled

Metastatic Colorectal Cancer2 trials

Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01105377·47 enrolled

To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer

Completed·—·Phase 1·NCT03215264·20 enrolled

Adult Subject2 trials

A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

Completed·SSyndax Pharmaceuticals·Phase 1·NCT02922933·66 enrolled

A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects

Completed·SSyndax Pharmaceuticals·Phase 1·NCT03187015·26 enrolled

33 more indications

Renal Cell Carcinoma2 trials

Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

Terminated·RRoberto Pili·Phase 2·NCT03552380·12 enrolled

Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma

Terminated·RRoberto Pili·Phase 1/2·NCT03024437·31 enrolled

Lung Cancer2 trials

Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04631029·3 enrolled

Azacitidine and Entinostat in Treating Patients With Newly Diagnosed Stage IA-IIIA Non-Small Lung Cancer Undergoing Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01886573·40 enrolled

Chronic Myelomonocytic Leukemia2 trials

MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00101179·63 enrolled

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00313586·197 enrolled

Bladder Cancer2 trials

Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Not yet recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 1/2·NCT07261592·29 enrolled

Window of Opportunity Platform Study to Define Immunogenomic Changes With Pembrolizumab Alone and in Rational Combinations in Muscle-Invasive Bladder Cancer

Active, not recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT03978624·20 enrolled

Myelodysplastic Syndrome2 trials

Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02936752·28 enrolled

MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00462605·24 enrolled

Acute Lymphoblastic Leukemia2 trials

Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT01383447·2 enrolled

Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01132573·27 enrolled

Pancreatic Adenocarcinoma2 trials

A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03250273·44 enrolled

A Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma

Withdrawn·—·Phase 1·NCT03760614

Postmenopausal Women2 trials

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

Completed·SSyndax Pharmaceuticals·Phase 1·NCT02820961·61 enrolled

Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT01234532·5 enrolled

Anatomic Stage III Breast Cancer AJCC v82 trials

A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02115282·608 enrolled

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02453620·57 enrolled

Prostate Cancer1 trial

Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer

Terminated·GGeorge Washington University·Phase 1·NCT03829930·6 enrolled

Advanced Solid Tumors1 trial

Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors

Completed·SSyndax Pharmaceuticals·Phase 1·NCT02897778·30 enrolled

Patients With Advanced Solid Tumors1 trial

Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Completed·SSyndax Pharmaceuticals·Phase 1·NCT02909452·30 enrolled

Fallopian Tube Cancer1 trial

Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03924245·3 enrolled

Ovarian Cancer1 trial

Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer

Completed·SSyndax Pharmaceuticals·Phase 1/2·NCT02915523·140 enrolled

Endometrial Cancer1 trial

Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03018249·50 enrolled

Esophageal Cancer1 trial

Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT05898828

Non-Small Cell Lung Carcinoma1 trial

A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib

Terminated·SSyndax Pharmaceuticals·Phase 2·NCT00750698·8 enrolled

Tumor1 trial

Entinostat Neuroendocrine (NE) Tumor

Terminated·AAntonio Fojo·Phase 2·NCT03211988·5 enrolled

Melanoma1 trial

An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT03765229·11 enrolled

Tics1 trial

Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat

Completed·SSyndax Pharmaceuticals·Phase 1·NCT02922946·47 enrolled

Recurrent or Refractory Solid Tumors1 trial

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02780804·21 enrolled

Newly Diagnosed1 trial

Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT03361800·5 enrolled

Advanced NSCLC1 trial

Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC

Completed·SSyndax Pharmaceuticals·Phase 1/2·NCT00602030·141 enrolled

Metastatic Melanoma1 trial

Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

Completed·VVastra Gotaland Region·Phase 2·NCT02697630·29 enrolled

Impaired Renal Function1 trial

A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function

Completed·SSyndax Pharmaceuticals·Phase 1·NCT03192111·40 enrolled

Acute Myeloid Leukemia1 trial

Entinostat and Sorafenib Tosylate in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory or Relapsed Acute Myeloid Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01159301·44 enrolled

Hematologic Cancer1 trial

MS-275 in Treating Patients With Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00015925

Phase II1 trial

Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01928576·143 enrolled

RCC1 trial

High Dose IL 2 and Entinostat in RCC

Active, not recruiting·RRoberto Pili·Phase 2·NCT03501381·46 enrolled

Soft Tissue Sarcoma1 trial

A Single-Center Clinical Study Evaluating the Safety and Antitumor Activity of Entinostat in Children With Malignant Soft Tissue Sarcoma Harboring PAX-family Gene Abnormalities

Recruiting·BBeijing Tongren Hospital·Phase 1·NCT07888114·16 enrolled

Oropharyngeal Cancer1 trial

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT04708470·55 enrolled

Clear Cell Renal Cell Carcinoma1 trial

Phase I/II Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT01038778·47 enrolled

Advanced Malignant Solid Neoplasm1 trial

Phase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05053971·49 enrolled

Sources

References

[1]
ClinicalTrials.gov — 73 trial records for Entinostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Entinostat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Entinostat. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Syndax Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histone Deacetylase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSyndax Pharmaceuticals

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