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    DRUG:

    Niktimvo (axatilimab-csfr)

    i
    Other names: INCA-034176, SNDX6352, UCB-6352, SNDX-6352, UCB 6352, UCB6352, SNDX 6352, INCA34176, INCA034176
    Associations

    News

    Trials
    Company:
    Incyte, Knight Therap, Royalty, Specialised Therap, Syndax Pharma, UCB
    Drug class:
    CSF-1R inhibitor
    Related drugs:
    Associations

    News

    Trials
    5d
    NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, University of Utah | Trial completion date: Apr 2028 --> Nov 2028 | Trial primary completion date: May 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Niktimvo (axatilimab-csfr)
    19d
    INCA34176-254: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=130, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    1m
    INCA034176-256: A Phase 2, Randomized, Open-Label Study Of 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) (2025-521849-25-00)
    P1/2, N=42, Recruiting, Incyte Corp. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Niktimvo (axatilimab-csfr)
    1m
    NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, University of Utah | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Opdivo (nivolumab) • Niktimvo (axatilimab-csfr)
    1m
    INCA34176-254: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Recruiting, Incyte Corporation | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    2ms
    ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Stephen Shiao | Trial completion date: Dec 2032 --> Jul 2033 | Initiation date: Sep 2025 --> Jun 2026 | Trial primary completion date: Dec 2032 --> Jul 2033
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    2ms
    Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=35, Recruiting, Stephen Shiao | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    2ms
    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 (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Mayo Clinic | Trial completion date: Jan 2033 --> Jun 2033 | Initiation date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2028 --> Jun 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    cyclophosphamide • Niktimvo (axatilimab-csfr)
    2ms
    INCA34176-254: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    2ms
    Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Northside Hospital, Inc.
    New P1 trial
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 deletion
    |
    Venclexta (venetoclax) • decitabine • Niktimvo (axatilimab-csfr)
    3ms
    SNDX-6352-0506: MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=145, Active, not recruiting, Syndax Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Niktimvo (axatilimab-csfr)
    3ms
    AGAVE-201: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov)
    P2, N=241, Active, not recruiting, Syndax Pharmaceuticals | Trial completion date: Dec 2027 --> Sep 2027
    Trial completion date
    |
    CSF1 (Colony stimulating factor 1)
    |
    Niktimvo (axatilimab-csfr)