^
    5d
    Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=630, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    10d
    STELLA: A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=442, Recruiting, Artios Pharma Ltd | Trial completion date: Dec 2026 --> Dec 2027
    Trial completion date
    |
    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    gemcitabine • irinotecan • alnodesertib (ART0380)
    12d
    Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (clinicaltrials.gov)
    P1, N=51, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • ceralasertib (AZD6738)
    14d
    Targeted therapy for DNA damage response and homologous recombination repair defects: The Olaparib Combinations trial. (PubMed, Cancer)
    The study failed to meet its primary end point of ORR. DDR and homologous recombination repair defects are not consistently actionable with olaparib as monotherapy or in combination with other targeted therapies in a histology-agnostic manner.
    Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A)
    |
    ARID1A mutation
    |
    Lynparza (olaparib) • Truqap (capivasertib) • ceralasertib (AZD6738)
    15d
    ATR Blockade Potentiates the Effects of Genotoxic Agents In Vitro and Promotes Antitumor Immunity in a Mouse Model of Non-Small Cell Lung Cancer. (PubMed, Cancers (Basel))
    These results demonstrate that ATR blockade concurrently enhances the efficacy of genotoxic agents and immune checkpoint inhibitors, thus paving the way for combination therapies in NSCLC.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    cisplatin • ceralasertib (AZD6738)
    1m
    D5330C00004: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents (clinicaltrials.gov)
    P1/2, N=357, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    HER-2 negative • HRD • PALB2 mutation • RAD51C mutation • BRCA mutation
    |
    Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • ceralasertib (AZD6738) • saruparib (AZD5305)
    1m
    TUVASTRAT: Tuvusertib in Astrocytoma With ATRX Mutation (clinicaltrials.gov)
    P2, N=56, Recruiting, Grupo Español de Investigación en Neurooncología
    New P2 trial
    |
    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ATRX (ATRX Chromatin Remodeler)
    |
    TP53 mutation
    |
    tuvusertib (M1774)
    1m
    Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2028 --> Jun 2026 | Trial primary completion date: Jan 2028 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    BRCA1 mutation • HRD
    |
    Zejula (niraparib) • tuvusertib (M1774) • lartesertib (M4076)
    1m
    GEINO-2401: Efficacy of Tuvusertib in Recurrent IDH mutant Astrocytoma with ATRX mutation, a phase II prospective trial. (2025-521843-19-00)
    P1/2, N=56, Recruiting, Grupo Espanol De Investigacion En Neurooncologia
    New P1/2 trial
    |
    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ATRX (ATRX Chromatin Remodeler)
    |
    TP53 mutation
    |
    tuvusertib (M1774)
    1m
    Design, synthesis and anti-breast cancer activity evaluation of 6,7-dihydro-5H-pyrrolo[3,4-d]pyrimidine-based PARP1/ATR dual inhibitors. (PubMed, J Enzyme Inhib Med Chem)
    Mechanistically, 38a arrested cell cycle progression, induced apoptosis, inhibited colony formation and migration, and suppressed DNA damage repair pathways, outperforming combined Niraparib and AZD6738. These findings underscore the therapeutic potential of PARP1/ATR dual inhibitors for breast cancer and support further investigation.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Zejula (niraparib) • ceralasertib (AZD6738)
    1m
    Efficacy of the ATR inhibitor ceralasertib in patients with ARID1A-deficient gynecologic and other solid tumor malignancies. (PubMed, Clin Cancer Res)
    Ceralasertib monotherapy demonstrated promising anti-tumor activity in ARID1A-deficient gynecologic malignancies. Tumor molecular and immune correlates may inform the further development of ATR inhibitors in this patient population.
    Journal
    |
    ARID1A (AT-rich interaction domain 1A)
    |
    ARID1A mutation
    |
    ceralasertib (AZD6738)
    2ms
    Targeting Galectin-9 to overcome immunosuppression and potentiate ATR inhibitor therapy. (PubMed, Cancer Lett)
    CD8+ T cell depletion completely abrogates the anti-tumor effects, suggesting their essential role in mediating therapeutic responses. These findings establish Gal-9 upregulation as a critical adaptive immune resistance mechanism constraining ATRi efficacy, providing a compelling rationale for clinical translation of ceralasertib/Gal-9 blockade combinations.
    Journal
    |
    CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • STING (stimulator of interferon response cGAMP interactor 1) • LGALS9 (Galectin 9)
    |
    ceralasertib (AZD6738)