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    DRUG:

    ceralasertib (AZD6738)

    i
    Other names: AZD6738, AZD 6738, AZD-6738
    Company:
    AstraZeneca
    Drug class:
    ATR inhibitor
    Related drugs:
    4d
    Novel therapeutic potential of the PARP inhibitor talazoparib in synovial sarcoma and its combined effect with ATR inhibitor. (PubMed, Discov Oncol)
    Talazoparib combined with ATR inhibitor possesses potential application as a therapeutic option for SS.
    Journal • PARP Biomarker
    |
    CHEK1 (Checkpoint kinase 1) • ANXA5 (Annexin A5)
    |
    Talzenna (talazoparib) • ceralasertib (AZD6738)
    6d
    EFFORT: Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • adavosertib (AZD1775) • ceralasertib (AZD6738)
    14d
    Targeting the DNA damage response prevents regrowth of colorectal peritoneal metastasis-derived organoids following treatment with mitomycin C. (PubMed, Br J Cancer)
    PMDOs can be completely eradicated if MMC treatment is followed by inhibition of ATR or other DDR kinases. DDR inhibitors may therefore have value in the adjuvant treatment of peritoneal metastases following CRS-HIPEC.
    Journal
    |
    CHEK1 (Checkpoint kinase 1)
    |
    oxaliplatin • adavosertib (AZD1775) • irinotecan • berzosertib (M6620) • ceralasertib (AZD6738) • elimusertib (BAY 1895344) • mitomycin • rabusertib (LY 2603618)
    1m
    AUSTRAL: Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen (clinicaltrials.gov)
    P2, N=21, Recruiting, Mario Negri Institute for Pharmacological Research | Not yet recruiting --> Recruiting | Trial completion date: Jan 2028 --> Jan 2029 | Trial primary completion date: Jan 2027 --> Jun 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    1m
    A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, AstraZeneca | Trial completion date: Oct 2025 --> Mar 2026
    Trial completion date
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)
    2ms
    Ceralasertib, an ATR kinase inhibitor, as monotherapy in Japanese patients with advanced solid malignancies: Results from a phase 1 study. (PubMed, Invest New Drugs)
    Ceralasertib monotherapy was generally well tolerated in Japanese patients with advanced solid tumors. The small number of patients enrolled prevents definitive conclusions on the efficacy of ceralasertib monotherapy to be made.
    P1 data • Journal
    |
    ATR (Ataxia telangiectasia and Rad3-related protein)
    |
    ceralasertib (AZD6738)
    2ms
    LATIFY: A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy (clinicaltrials.gov)
    P3, N=594, Active, not recruiting, AstraZeneca | Trial completion date: Oct 2025 --> Oct 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    Imfinzi (durvalumab) • docetaxel • ceralasertib (AZD6738)
    3ms
    The Prognostic and Predictive Impact of Circulating Tumour DNA Levels in Patients with Advanced Breast Cancer Enrolled on the plasmaMATCH Trial. (PubMed, Clin Cancer Res)
    Baseline low ctDNA levels predict response to targeted therapy, potentially suggesting shared mechanisms between high ctDNA release and resistance to therapy. Both baseline ctDNA levels and on-treatment dynamics are a promising surrogate endpoint for drug development, with clearance of ctDNA being a robust cross-therapy surrogate for outcome.
    Journal • BRCA Biomarker • PARP Biomarker • Circulating tumor DNA
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2)
    |
    Guardant360® CDx • GuardantOMNI
    |
    Lynparza (olaparib) • ceralasertib (AZD6738)
    3ms
    S2409: Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study (clinicaltrials.gov)
    P2, N=900, Recruiting, SWOG Cancer Research Network | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SLFN11 (Schlafen Family Member 11)
    |
    Imfinzi (durvalumab) • etoposide IV • ceralasertib (AZD6738) • saruparib (AZD5305) • monalizumab (IPH2201)
    4ms
    AZD6738 for Patients With Progressive MDS or CMML (clinicaltrials.gov)
    P1, N=52, Active, not recruiting, Massachusetts General Hospital | Recruiting --> Active, not recruiting | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2024 --> Apr 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    SF3B1 (Splicing Factor 3b Subunit 1) • SRSF2 (Serine and arginine rich splicing factor 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    SF3B1 mutation
    |
    ceralasertib (AZD6738)
    4ms
    LOTOS: A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, AstraZeneca | Trial completion date: Jul 2025 --> Jan 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    Imfinzi (durvalumab) • ceralasertib (AZD6738)