Axatilimab

Generic Name: Axatilimab

Drug Type: Biotech

CAS Number: 2155851-88-8

Unique Ingredient Identifier: R96Z451BMC

Background: Axatilimab is under investigation in clinical trial NCT04301778 (Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-embolization for Patients With Intrahepatic Cholangiocarcinoma).

Clinical Trials

A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD

Phase 1

Recruiting

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: INCA034176

First Posted Date: 2025-02-25

Last Posted Date: 2025-05-13

Lead Sponsor: Incyte Corporation

Target Recruit Count: 30

Registration Number: NCT06843408

Locations: 🇨🇳
Peking University People'S Hospital, Beijing, China
🇨🇳
Shanghai Children'S Medical Center, Shanghai, China
🇨🇳
West China Hospital of Sichuan University, Chengdu, China

and more 5 locations

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

Phase 3

Recruiting

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: INCA034176
Drug: Best Available Therapy (BAT)

First Posted Date: 2025-02-12

Last Posted Date: 2025-05-21

Lead Sponsor: Incyte Corporation

Target Recruit Count: 300

Registration Number: NCT06821542

Locations: 🇮🇹
Aou Policlinico Umberto I, Roma, Italy
🇦🇹
Medical University of Graz, Graz, Austria
🇦🇹
Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii, Innsbruck, Austria

and more 128 locations

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

Phase 1

Recruiting

Conditions: Healthy Participants

Interventions: Drug: Axatilimab

First Posted Date: 2024-12-03

Last Posted Date: 2025-05-02

Lead Sponsor: Incyte Corporation

Target Recruit Count: 72

Registration Number: NCT06713590

Locations: 🇺🇸
Celerion, Inc, Tempe, Arizona, United States

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

Phase 2

Recruiting

Conditions: Chronic Graft Versus Host Disease
cGVHD

Interventions: Biological: Axatilimab
Procedure: Extracorporeal Photopheresis

First Posted Date: 2024-10-29

Last Posted Date: 2025-05-20

Lead Sponsor: University of Miami

Target Recruit Count: 49

Registration Number: NCT06663722

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

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

Phase 3

Recruiting

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: INCA034176
Drug: Placebo
Drug: Corticosteroids

First Posted Date: 2024-09-19

Last Posted Date: 2025-05-15

Lead Sponsor: Incyte Corporation

Target Recruit Count: 240

Registration Number: NCT06585774

Locations: 🇮🇹
Azienda Ospedaliera Card. G. Panico, Tricase, Italy
🇪🇸
Hospital Puerta de Hierro, Majadahonda, Spain
🇬🇧
Bristol Haematology and Oncology Centre, Bristol, United Kingdom

and more 52 locations

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

Phase 1

Suspended

Conditions: Atypical Chronic Myeloid Leukemia
Refractory Chronic Myelomonocytic Leukemia
Refractory Myelodysplastic/Myeloproliferative Neoplasm
Refractory Myeloproliferative Neoplasm
Chronic Myelomonocytic Leukemia
Recurrent Myelodysplastic/Myeloproliferative Neoplasm
Recurrent Myeloproliferative Neoplasm
Myelodysplastic/Myeloproliferative Neoplasm

Interventions: Biological: Axatilimab
Procedure: Biospecimen Collection
Drug: Azacitidine
Procedure: Bone Marrow Aspiration and Biopsy
Other: Survey Administration

First Posted Date: 2024-07-26

Last Posted Date: 2025-02-24

Lead Sponsor: Uma Borate

Target Recruit Count: 52

Registration Number: NCT06523556

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

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

Phase 2

Recruiting

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: Axatilimab
Drug: Corticosteroids
Drug: Ruxolitinib

First Posted Date: 2024-04-29

Last Posted Date: 2025-05-02

Lead Sponsor: Incyte Corporation

Target Recruit Count: 120

Registration Number: NCT06388564

Locations: 🇧🇪
Jessa Ziekenhuis, Hasselt, Belgium
🇧🇪
Universitair Ziekenhuis (Uz) Leuven, Leuven, Belgium
🇧🇪
Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan, Brugge, Belgium

and more 67 locations

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

Phase 1

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm

Interventions: Biological: Axatilimab
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Paclitaxel
Procedure: Positron Emission Tomography
Biological: Retifanlimab

First Posted Date: 2024-03-20

Last Posted Date: 2024-12-16

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 38

Registration Number: NCT06320405

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

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

Phase 3

Active, not recruiting

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: INCA034176

First Posted Date: 2024-02-16

Last Posted Date: 2025-02-05

Lead Sponsor: Incyte Biosciences Japan GK

Target Recruit Count: 21

Registration Number: NCT06263478

Locations: 🇯🇵
Okayama University Hospital, Okayama, Japan
🇯🇵
Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka, Japan
🇯🇵
Fujita Health University Hospital, Aichi, Japan

and more 13 locations

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Recruiting

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Axatilimab
Other: Placebo

First Posted Date: 2023-11-15

Last Posted Date: 2025-05-13

Lead Sponsor: Syndax Pharmaceuticals

Target Recruit Count: 135

Registration Number: NCT06132256

Locations: 🇮🇹
Policlinico Tor Vergata Rome, Rome, Italy
🇦🇺
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
🇦🇺
Sunshine Coast University Hospital, Birtinya, Queensland, Australia

and more 66 locations

Drug Development Updates

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