Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte 
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 0 Diseases   1 Trial   1 Trial   1 News 
17 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
INCA34176-358, NCT06263478: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease

Active, not recruiting
3
21
Japan
INCA034176, Axatilimab
Incyte Biosciences Japan GK
Chronic Graft-versus-host-disease
09/25
03/27
NCT06585774: A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Recruiting
3
240
Europe, Canada, Japan, US, RoW
INCA034176, Axatilimab, Placebo, Corticosteroids, prednisone, methylprednisolone, prednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
09/27
03/30
NCT06821542: A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

Not yet recruiting
3
300
NA
INCA034176, Axatilimab, Best Available Therapy (BAT), BAT could include:, • Calcineurin inhibitor (cyclosporine or tacrolimus), • Extracorporeal photopheresis (ECP), • Mycophenolate mofetil (MMF), • A mammalian target of rapamycin (mTOR) inhibitor (everolimus or sirolimus), • Rituximab, • Pentostatin, • Proteasome inhibitors, • Imatinib, • Ibrutinib
Incyte Corporation
Chronic Graft-versus-host-disease
05/28
11/32
NCT04301778: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

Completed
2
5
US
Durvalumab, MEDI4736, SNDX-6352, UCB6352
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Syndax Pharmaceuticals, AstraZeneca
Unresectable Intrahepatic Cholangiocarcinoma
11/22
02/24
AGAVE-201, NCT04710576 / 2020-005107-40: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Hourglass Jan 2025 - Mar 2025 : Market entry in US for chronic GVHD
Active, not recruiting
2
241
Europe, Canada, US, RoW
Axatilimab, Niktimvo, SNDX-6352
Syndax Pharmaceuticals, Syndax Pharmaceuticals, Inc., Syndax Pharmaceuticals, Inc
Chronic Graft-versus-host-disease
04/23
09/27
NCT06132256: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting
2
135
Europe, Canada, RoW
Axatilimab, Niktimvo, SNDX-6352, Placebo
Syndax Pharmaceuticals, DevPro Biopharma
Idiopathic Pulmonary Fibrosis
04/25
06/25
NCT06388564: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Recruiting
2
120
Europe, Canada, US
Axatilimab, Ruxolitinib, Corticosteroids, prednisone, prednisolone, methylprednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
06/27
12/29
NAHL, NCT05723055: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Recruiting
2
9
US
Axatilimab, SNDX6532, Nivolumab, OPDIVO
University of Utah, Incyte Corporation
Hodgkin Lymphoma
04/25
04/28
NCT06663722: Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

Not yet recruiting
2
49
US
Axatilimab, Extracorporeal Photopheresis, ECP
University of Miami, Incyte Corporation
Chronic Graft Versus Host Disease, cGVHD
04/30
04/30
NCT05491226: Reinvigorating TNBC Response to Immunotherapy with Combination Myeloid Inhibition and Radiation

Active, not recruiting
2
35
US
Pembrolizumab, Keytruda, Radiation Therapy, Axatilimab
Stephen Shiao, Merck Sharp & Dohme LLC, Incyte Corporation
TNBC - Triple-Negative Breast Cancer, Breast Cancer
12/26
12/26
SNDX-6352-0503, NCT03604692: A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

Completed
1/2
41
US
axatilimab, Niktimvo, SNDX-6352
Syndax Pharmaceuticals
Chronic Graft-versus-host-disease
08/22
10/24
NCT06320405: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

Recruiting
1/2
38
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Retifanlimab, INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012, MGA 012, MGA-012, MGA012, Retifanlimab-dlwr, Zynyz
OHSU Knight Cancer Institute, Oregon Health and Science University, Incyte Corporation
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
04/27
04/29
NCT06523556: 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

Suspended
1/2
52
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Survey Administration
Uma Borate, Incyte Corporation
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
12/25
12/26
NCT06843408: A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD

Not yet recruiting
1/2
30
NA
INCA034176, Axatilimab
Incyte Corporation
Chronic Graft-versus-host-disease
07/26
12/27
NCT06488378: Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Recruiting
1
20
NA
Axatilimab, SNDX-6352, Ab969.g2, C24H23FN4O3, Olaparib, Lynparza, AZD2281, KU-005943
Dana-Farber Cancer Institute, Incyte Corporation
Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
09/26
03/29
NCT06713590: A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

Recruiting
1
72
US
Axatilimab
Incyte Corporation
Healthy Participants
06/25
06/25
NCT05544032: Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

Available
N/A
NA
axatilimab, INCA34176
Incyte Corporation
Chronic Graft Vs. Host Disease
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
INCA34176-358, NCT06263478: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease

Active, not recruiting
3
21
Japan
INCA034176, Axatilimab
Incyte Biosciences Japan GK
Chronic Graft-versus-host-disease
09/25
03/27
NCT06585774: A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Recruiting
3
240
Europe, Canada, Japan, US, RoW
INCA034176, Axatilimab, Placebo, Corticosteroids, prednisone, methylprednisolone, prednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
09/27
03/30
NCT06821542: A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

Not yet recruiting
3
300
NA
INCA034176, Axatilimab, Best Available Therapy (BAT), BAT could include:, • Calcineurin inhibitor (cyclosporine or tacrolimus), • Extracorporeal photopheresis (ECP), • Mycophenolate mofetil (MMF), • A mammalian target of rapamycin (mTOR) inhibitor (everolimus or sirolimus), • Rituximab, • Pentostatin, • Proteasome inhibitors, • Imatinib, • Ibrutinib
Incyte Corporation
Chronic Graft-versus-host-disease
05/28
11/32
NCT04301778: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

Completed
2
5
US
Durvalumab, MEDI4736, SNDX-6352, UCB6352
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Syndax Pharmaceuticals, AstraZeneca
Unresectable Intrahepatic Cholangiocarcinoma
11/22
02/24
AGAVE-201, NCT04710576 / 2020-005107-40: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Hourglass Jan 2025 - Mar 2025 : Market entry in US for chronic GVHD
Active, not recruiting
2
241
Europe, Canada, US, RoW
Axatilimab, Niktimvo, SNDX-6352
Syndax Pharmaceuticals, Syndax Pharmaceuticals, Inc., Syndax Pharmaceuticals, Inc
Chronic Graft-versus-host-disease
04/23
09/27
NCT06132256: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting
2
135
Europe, Canada, RoW
Axatilimab, Niktimvo, SNDX-6352, Placebo
Syndax Pharmaceuticals, DevPro Biopharma
Idiopathic Pulmonary Fibrosis
04/25
06/25
NCT06388564: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Recruiting
2
120
Europe, Canada, US
Axatilimab, Ruxolitinib, Corticosteroids, prednisone, prednisolone, methylprednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
06/27
12/29
NAHL, NCT05723055: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Recruiting
2
9
US
Axatilimab, SNDX6532, Nivolumab, OPDIVO
University of Utah, Incyte Corporation
Hodgkin Lymphoma
04/25
04/28
NCT06663722: Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

Not yet recruiting
2
49
US
Axatilimab, Extracorporeal Photopheresis, ECP
University of Miami, Incyte Corporation
Chronic Graft Versus Host Disease, cGVHD
04/30
04/30
NCT05491226: Reinvigorating TNBC Response to Immunotherapy with Combination Myeloid Inhibition and Radiation

Active, not recruiting
2
35
US
Pembrolizumab, Keytruda, Radiation Therapy, Axatilimab
Stephen Shiao, Merck Sharp & Dohme LLC, Incyte Corporation
TNBC - Triple-Negative Breast Cancer, Breast Cancer
12/26
12/26
SNDX-6352-0503, NCT03604692: A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

Completed
1/2
41
US
axatilimab, Niktimvo, SNDX-6352
Syndax Pharmaceuticals
Chronic Graft-versus-host-disease
08/22
10/24
NCT06320405: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

Recruiting
1/2
38
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Retifanlimab, INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012, MGA 012, MGA-012, MGA012, Retifanlimab-dlwr, Zynyz
OHSU Knight Cancer Institute, Oregon Health and Science University, Incyte Corporation
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
04/27
04/29
NCT06523556: 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

Suspended
1/2
52
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Survey Administration
Uma Borate, Incyte Corporation
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
12/25
12/26
NCT06843408: A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD

Not yet recruiting
1/2
30
NA
INCA034176, Axatilimab
Incyte Corporation
Chronic Graft-versus-host-disease
07/26
12/27
NCT06488378: Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Recruiting
1
20
NA
Axatilimab, SNDX-6352, Ab969.g2, C24H23FN4O3, Olaparib, Lynparza, AZD2281, KU-005943
Dana-Farber Cancer Institute, Incyte Corporation
Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
09/26
03/29
NCT06713590: A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

Recruiting
1
72
US
Axatilimab
Incyte Corporation
Healthy Participants
06/25
06/25
NCT05544032: Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

Available
N/A
NA
axatilimab, INCA34176
Incyte Corporation
Chronic Graft Vs. Host Disease
 
 

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