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    DRUG:

    alnodesertib (ART0380)

    i
    Other names: ART0380, ART 0380, IACS-030380, ART-0380
    Associations

    News

    Trials
    Company:
    Artios Pharma
    Drug class:
    ATR inhibitor
    Related drugs:
    Associations

    News

    Trials
    22d
    Targeting ATR-CHK1 and ATM-CHK2 Axes in Pancreatic Cancer-A Comprehensive Review of Literature. (PubMed, Int J Mol Sci)
    Preclinical studies demonstrate that ATR inhibition disrupts replication stress tolerance, impairs homologous recombination, and disables checkpoint control, enhancing cytotoxicity from standard therapies including gemcitabine, FOLFIRINOX, fluoropyrimidines, and radiotherapy...Early-phase clinical trials of ATR inhibitors (ART0380, AZD6738, BBI-355) alone or in combination show promising safety, tolerability, and preliminary efficacy. In this review, we summarize current literature on targeting the ATM-CHK2 and ATR-CHK1 pathways in PC, highlighting preclinical evidence, clinical developments, and strategies for biomarker-driven, precision oncology approaches.
    Review • Journal • PARP Biomarker
    |
    ARID1A (AT-rich interaction domain 1A) • CHEK2 (Checkpoint kinase 2) • CHEK1 (Checkpoint kinase 1)
    |
    gemcitabine • 5-fluorouracil • irinotecan • ceralasertib (AZD6738) • leucovorin calcium • alnodesertib (ART0380)
    1m
    Recent advances in small molecule ATR kinase inhibitors as anticancer agents. (PubMed, Future Med Chem)
    Over the last decade, intensive medicinal chemistry efforts have generated a broad pipeline of ATR inhibitors, including ceralasertib, elimusertib, camonsertib, berzosertib, ART0380, and gartisertib, many of which are in Phase I/II clinical trials. Incorporating these strategies into adaptive platform trials with pharmacodynamic markers and patient-centered outcomes will speed up translation. Overall, ATR inhibitors highlight progress in DNA damage response therapies, from understanding mechanisms to biomarker-driven clinical use, with the potential to revolutionize treatment across various cancers.
    Review • Journal • PARP Biomarker • IO biomarker
    |
    RAD51 (RAD51 Homolog A)
    |
    berzosertib (M6620) • ceralasertib (AZD6738) • elimusertib (BAY 1895344) • alnodesertib (ART0380) • camonsertib (RP-3500) • gartisertib (M4344)
    9ms
    ARTIST: Study of ART0380 in Patients With Biologically Selected Solid Tumors (clinicaltrials.gov)
    P2, N=36, Terminated, Artios Pharma Ltd | Active, not recruiting --> Terminated; Sponsor decision, not for reasons affecting the benefit-risk balance.
    Trial termination • Pan tumor
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    alnodesertib (ART0380)
    9ms
    A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=597, Recruiting, Artios Pharma Ltd | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    gemcitabine • irinotecan • alnodesertib (ART0380)
    10ms
    ARTIST: Study of ART0380 in Patients With Biologically Selected Solid Tumors (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, Artios Pharma Ltd | Trial completion date: Mar 2025 --> Jul 2025
    Trial completion date • Pan tumor
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    alnodesertib (ART0380)
    over1year
    ARTIST: Study of ART0380 in Patients With Biologically Selected Solid Tumors (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Artios Pharma Ltd | Recruiting --> Active, not recruiting | N=60 --> 37 | Trial primary completion date: Mar 2025 --> Nov 2024
    Enrollment closed • Enrollment change • Trial primary completion date • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    alnodesertib (ART0380)
    2years
    Ataxia-Telangiectasia Mutated (ATM) loss of function displays variant and tissue-specific differences across tumor types. (PubMed, Clin Cancer Res)
    These data help to better define ATM LOF across tumor types in order to optimize patient selection and improve molecularly targeted therapeutic approaches for patients with ATM LOF cancers.
    Journal
    |
    ATM (ATM serine/threonine kinase)
    |
    ATM mutation
    |
    alnodesertib (ART0380)
    2years
    A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=372, Recruiting, Artios Pharma Ltd | N=242 --> 372
    Enrollment change • Metastases
    |
    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    gemcitabine • irinotecan • alnodesertib (ART0380)
    over2years
    ARTIST: Study of ART0380 in Advanced/Metastatic Solid Tumors Patients (clinicaltrials.gov)
    P2, N=60, Recruiting, Artios Pharma Ltd | Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Sep 2023
    Enrollment open • Trial initiation date • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    alnodesertib (ART0380)
    almost3years
    ARTIST: Study of ART0380 in Advanced/Metastatic Solid Tumors Patients (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Artios Pharma Ltd
    New P2 trial • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    alnodesertib (ART0380)
    3years
    A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=242, Recruiting, Artios Pharma Ltd | Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    gemcitabine • irinotecan • alnodesertib (ART0380)
    5years
    A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Artios Pharma Ltd | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    gemcitabine • alnodesertib (ART0380)