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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
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Recruiting Phase 2 Interventional

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

NCT05491226
View directory record Official record
Conditions
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Interventions
Pembrolizumab, Radiation Therapy, Axatilimab
Drug · Radiation
Lead sponsor
Stephen Shiao
Other
Eligibility
18 Years and older · Female only
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 19, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

NCT06713590
View directory record Official record
Conditions
Healthy Participants
Interventions
Axatilimab
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
18 Years to 55 Years
Enrollment
72 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Jun 24, 2025 · Synced Sep 3, 2026, 9:45 AM EDT
Not yet recruiting Phase 1 Interventional

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML

NCT07511062
View directory record Official record
Conditions
Acute Myeloid Leukemia, TP53 Gene Mutation
Interventions
Decitabine, Venetoclax, Axatilimab
Drug
Lead sponsor
Northside Hospital, Inc.
Other
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 5, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 1Phase 2 Interventional

Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

NCT06320405
View directory record Official record
Conditions
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
Interventions
Axatilimab, Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Paclitaxel, Positron Emission Tomography, Retifanlimab
Biological · Procedure · Drug
Lead sponsor
OHSU Knight Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 1Phase 2 Interventional

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

NCT07128381
View directory record Official record
Conditions
Myelofibrosis (MF), Chronic Myelomonocytic Leukemia (CMML)
Interventions
Axatilimab (SNDX-6352), Ruxolitinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Terminated Phase 2 Interventional Results available

A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19

NCT04415073
View directory record Official record
Conditions
Coronavirus, COVID, ARDS, Cytokine Storm, Cytokine Release Syndrome
Interventions
SNDX-6352, Placebo
Drug
Lead sponsor
Syndax Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
2
States / cities
Scottsdale, Arizona • The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Jul 21, 2022 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 1 Interventional

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

NCT06488378
View directory record Official record
Conditions
Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Interventions
Axatilimab, Olaparib
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
2
States / cities
Boston, Massachusetts • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

NCT07124078
View directory record Official record
Conditions
Chronic Graft-versus-host-disease
Interventions
INCA034176, Best available Treatment (BAT)
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
2 Years to 17 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
11
States / cities
Duarte, California • Los Angeles, California • Palo Alto, California + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Completed Phase 1Phase 2 Interventional Results available

A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

NCT03604692
View directory record Official record
Conditions
Chronic Graft-versus-host-disease
Interventions
axatilimab
Drug
Lead sponsor
Syndax Pharmaceuticals
Industry
Eligibility
6 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
11
States / cities
Birmingham, Alabama • Duarte, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 3, 2026, 9:45 AM EDT
Withdrawn Phase 2 Interventional

Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial

NCT07349771
View directory record Official record
Conditions
Hematopoietic and Lymphatic System Neoplasm
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Axatilimab, Biospecimen Collection, Bone Marrow Aspiration, Computed Tomography, Cyclophosphamide, Magnetic Resonance Imaging, Mycophenolate Mofetil, Placebo Administration, Positron Emission Tomography, Skin Biopsy, Tacrolimus, X-Ray Imaging
Procedure · Biological · Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
3
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Active, not recruiting Phase 2 Interventional

Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

NCT05723055
View directory record Official record
Conditions
Hodgkin Lymphoma
Interventions
Axatilimab, Nivolumab
Drug
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
2
States / cities
Detroit, Michigan • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 2 Interventional

Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

NCT07011810
View directory record Official record
Conditions
Chronic Graft Versus Host Disease
Interventions
Axatilimab, Biospecimen Collection, Questionnaire Administration, Skin Biopsy, Skin Measurement
Biological · Procedure · Other
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
3
States / cities
Tampa, Florida • Boston, Massachusetts • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 1 Interventional

A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)

NCT06959537
View directory record Official record
Conditions
Breast Cancer
Interventions
Cyclophosphamide, Axatilimab (SNDX-6352), Retifanlimab
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 2 Interventional

Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

NCT06663722
View directory record Official record
Conditions
Chronic Graft Versus Host Disease, cGVHD
Interventions
Axatilimab, Extracorporeal Photopheresis
Biological · Procedure
Lead sponsor
University of Miami
Other
Eligibility
12 Years and older
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
3
States / cities
San Francisco, California • Miami, Florida • Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774
View directory record Official record
Conditions
Chronic Graft-versus-host-disease
Interventions
INCA034176, Placebo, Corticosteroids
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
12 Years and older
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
36
States / cities
Birmingham, Alabama • Tucson, Arizona • Duarte, California + 31 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Not yet recruiting No phase listed Observational

Effects of Axatilimab on Skin in Chronic Graft-versus-Host Disease

NCT07728708
View directory record Official record
Conditions
Chronic Graft vs. Host Disease, GVHD, cGVHD, Graft Versus Host Disease in Skin
Interventions
Axatilimab
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Active, not recruiting Phase 2 Interventional

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564
View directory record Official record
Conditions
Chronic Graft-versus-host-disease
Interventions
Axatilimab, Ruxolitinib, Corticosteroids
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
12 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
25
States / cities
Phoenix, Arizona • Duarte, California • Los Angeles, California + 18 more
Source: ClinicalTrials.gov public record
Updated May 21, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 1Phase 2 Interventional

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

NCT06523556
View directory record Official record
Conditions
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Myeloproliferative Neoplasm
Interventions
Axatilimab, Azacitidine, Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Survey Administration
Biological · Drug · Procedure + 1 more
Lead sponsor
Uma Borate
Other
Eligibility
18 Years and older
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Not yet recruiting Phase 2 Interventional

ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation

NCT07015853
View directory record Official record
Conditions
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Interventions
Pembrolizumab, Radiotherapy, Axatilimab
Drug · Radiation
Lead sponsor
Stephen Shiao
Other
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 19, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Completed Phase 1 Interventional

A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

NCT03238027
View directory record Official record
Conditions
Solid Tumor, Metastatic Tumor, Locally Advanced Malignant Neoplasm, Unresectable Malignant Neoplasm
Interventions
Axatilimab, Durvalumab
Drug
Lead sponsor
Syndax Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
5
States / cities
Scottsdale, Arizona • Baltimore, Maryland • Portland, Oregon + 1 more
Source: ClinicalTrials.gov public record
Updated May 16, 2024 · Synced Sep 3, 2026, 9:45 AM EDT
Not yet recruiting Phase 1 Interventional

Axatilimab + CAR-T for High-Risk Lymphoma

NCT07638982
View directory record Official record
Conditions
Diffuse Large B Cell Lymphoma (DLBCL), Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma (HGBCL), High-Grade B-Cell Lymphoma, Nos, PMBCL, Follicular Grade 3 Lymphoma
Interventions
Axatilimab
Drug
Lead sponsor
Northside Hospital, Inc.
Other
Eligibility
8 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Completed Phase 2 Interventional Results available

Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

NCT04301778
View directory record Official record
Conditions
Unresectable Intrahepatic Cholangiocarcinoma
Interventions
Durvalumab, SNDX-6352
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 12, 2026 · Synced Sep 3, 2026, 9:45 AM EDT
Recruiting Phase 2 Interventional Results available

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

NCT04710576
View directory record Official record
Conditions
Chronic Graft-versus-host-disease
Interventions
Axatilimab
Drug
Lead sponsor
Syndax Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
47
States / cities
Birmingham, Alabama • Duarte, California • Los Angeles, California + 37 more
Source: ClinicalTrials.gov public record
Updated Jun 15, 2026 · Synced Sep 3, 2026, 9:45 AM EDT