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    DRUG CLASS:

    Cytidine deaminase inhibitor

    Related drugs:
    8d
    A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancer. (PubMed, Cancer)
    ASTX727 plus talazoparib produces significant myelosuppression without other adverse events. Modest methylation changes in PBMCs were detected. There were no objective responses, but some heavily pretreated patients had stable disease for >4 months despite the attenuated doses.
    P1 data • Journal • BRCA Biomarker • PARP Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset) • DNMT1 (DNA methyltransferase 1)
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    HER-2 negative • BRCA mutation
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    Talzenna (talazoparib) • Inqovi (decitabine/cedazuridine)
    9d
    Serial Determinations of Molecular Aberrations in Patients with Acute Myeloid Leukemia During Treatment with Oral Decitabine/Cedazuridine. (PubMed, Cancers (Basel))
    Disease-modifying activity with decreases in mutated clones is rare. Although the exact mechanism behind our findings remains undetermined, they are in line with the proposed effects of HMA on epigenetics in leukemia cells.
    Journal
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    FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1)
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    IDH2 mutation • NPM1 mutation • RAS mutation
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    Inqovi (decitabine/cedazuridine)
    28d
    NIBIT-ML-1: A randomized, run-in, phase II study of nivolumab combined with ipilimumab and oral decitabine/cedazuridine (ASTX727) or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 (2024-518891-29-00)
    P1/2, N=148, Recruiting, Fondazione NIBIT Onlus | Not yet recruiting --> Recruiting
    Enrollment open
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation • BRAF mutation • ALK translocation
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • Inqovi (decitabine/cedazuridine)
    1m
    ASTX030-01: A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) (clinicaltrials.gov)
    P2/3, N=316, Recruiting, Taiho Oncology, Inc. | N=236 --> 316 | Trial completion date: May 2028 --> Nov 2028 | Trial primary completion date: May 2027 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
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    Venclexta (venetoclax) • cedazuridine/azacitidine (ASTX030)
    1m
    ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (clinicaltrials.gov)
    P1/2, N=31, Not yet recruiting, University of Wisconsin, Madison
    New P1/2 trial
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    Inqovi (decitabine/cedazuridine) • Zynyz (retifanlimab-dlwr)
    1m
    ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jan 2027
    Trial completion date
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    Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)
    2ms
    Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PML (Promyelocytic Leukemia)
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    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    2ms
    Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=93, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation
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    Venclexta (venetoclax) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    ASTX660-03: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Taiho Oncology, Inc. | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2026 --> Mar 2026
    Phase classification • Trial completion date
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    Inqovi (decitabine/cedazuridine) • tolinapant (ASTX660)
    2ms
    A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=47, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2026 --> Oct 2026
    Trial initiation date
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    CD4 (CD4 Molecule)
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    Inqovi (decitabine/cedazuridine) • Neupogen (filgrastim)
    3ms
    A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST) (clinicaltrials.gov)
    P2, N=25, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
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    SUZ12 (SUZ12 Polycomb Repressive Complex 2 Subunit)
    |
    EZH2 mutation
    |
    Inqovi (decitabine/cedazuridine)
    3ms
    ASTX727-03: Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS (clinicaltrials.gov)
    P1/2, N=160, Completed, Taiho Oncology, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    Inqovi (decitabine/cedazuridine)