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    DRUG:

    berzosertib (M6620)

    i
    Other names: M6620, VX-970, M 6620, VX970, VX 970, VE822, VE-822
    Company:
    EMD Serono, Vertex
    Drug class:
    ATR inhibitor
    Related drugs:
    4d
    Combined Inhibition of ATR and Ribonucleotide Reductase Induces Synergistic Antineoplastic Activity in Osteosarcoma Cells. (PubMed, Cancer Rep (Hoboken))
    Our study demonstrates that combined inhibition of ATR and RNR was effective in osteosarcoma cells. These in vitro findings offer support for investigating in vivo the potential of a combination of ATR and RNR inhibitors as a new treatment strategy for osteosarcoma.
    Journal
    |
    CASP3 (Caspase 3) • CASP7 (Caspase 7)
    |
    TP53 mutation • TP53 wild-type
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    berzosertib (M6620) • Triapine (3-AP) • didox (NSC-324360)
    11d
    IB 2018-04: Targeting ATR in soft-tissue sarcomas: a randomized phase II study (2023-509499-41-00)
    P1/2, N=72, Completed, Institut Bergonie | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • berzosertib (M6620)
    17d
    UM1CA186709: M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2026 --> Apr 2027
    Trial completion date
    |
    carboplatin • docetaxel • berzosertib (M6620)
    18d
    A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=120 --> 35
    Enrollment closed • Enrollment change
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • PPP2R2A (Protein Phosphatase 2, Regulatory Subunit B, Alpha)
    |
    BRCA1 mutation • ATM mutation • PALB2 mutation • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • CHEK1 mutation • RAD54L mutation
    |
    berzosertib (M6620) • Trodelvy (sacituzumab govitecan-hziy)
    21d
    Radiotherapy and DNA damage response inhibitors modestly sensitize HNSCC to NK cell killing, with ATM inhibition more effective than ATR inhibition. (PubMed, Strahlenther Onkol)
    Natural killer cells showed only a limited contribution to the killing of HNSCC cells pretreated with RT or RT + DDRi. However, a subset of patients with head and neck tumors-such as those represented by the HSC4 model-might still benefit from combining RT with ATMi rather than ATRi to enhance NK cell-mediated tumor killing.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    KLRC1 (Killer Cell Lectin Like Receptor C1)
    |
    Imfinzi (durvalumab) • berzosertib (M6620) • AZD0156 • monalizumab (IPH2201)
    1m
    Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> Mar 2027
    Trial completion date
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • berzosertib (M6620)
    1m
    MSTN and TCF12 as Candidate Immunometabolic Signatures in Glioma-Associated Foam Cells: Insights from Integrated Multi-Omics Analysis. (PubMed, Curr Issues Mol Biol)
    Additionally, drug sensitivity prediction analysis demonstrated that MSTN expression was significantly associated with sensitivity to paclitaxel and VE-822, while TCF12 expression showed potential associations with sensitivity to cytarabine, olaparib, Wee1 inhibitor, paclitaxel, and VE-822. Immunofluorescence confirmed upregulated expression of MSTN and TCF12 in glioma tissues and their co-localization with macrophages. In conclusion, this study identified TAFCs as the central cells in the glioma microenvironment, with their signature genes MSTN and TCF12 representing candidate immunometabolic signatures associated with macrophage-mediated immunosuppression and metabolic reprogramming in glioma, suggesting their potential as biomarkers for patient stratification and as targets for immunometabolic therapies.
    Journal • PARP Biomarker
    |
    TCF12 (Transcription Factor 12)
    |
    Lynparza (olaparib) • paclitaxel • cytarabine • berzosertib (M6620)
    2ms
    Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2025 --> May 2026
    Trial completion date
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • berzosertib (M6620)
    2ms
    A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors (clinicaltrials.gov)
    P1/2, N=120, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • PPP2R2A (Protein Phosphatase 2, Regulatory Subunit B, Alpha)
    |
    BRCA1 mutation • ATM mutation • PALB2 mutation • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • CHEK1 mutation • RAD54L mutation
    |
    berzosertib (M6620) • Trodelvy (sacituzumab govitecan-hziy)
    2ms
    NCI 9938: M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=66, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • ATM mutation • PALB2 mutation
    |
    irinotecan • berzosertib (M6620)
    2ms
    Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=120 --> 37 | Trial primary completion date: Aug 2026 --> Dec 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    berzosertib (M6620) • Zepzelca (lurbinectedin)
    2ms
    NCI 10211: Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • MSI (Microsatellite instability)
    |
    HER-2 positive • TP53 mutation • MSI-H/dMMR
    |
    FoundationOne® CDx
    |
    irinotecan • berzosertib (M6620)