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    DRUG:

    tuvusertib (M1774)

    i
    Other names: VRT1363004, VRT 1363004, M1774, M 1774, MSC2584415A, VXc-400, VR 1363004, M-1774, MSC 2584415A, VR1363004, VXc 400, MSC-2584415A, VR-1363004, VXc400, VRT-1363004
    Company:
    EMD Serono
    Drug class:
    ATR inhibitor
    Related drugs:
    7d
    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 primary completion date: Sep 2025 --> Jun 2026
    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)
    13d
    Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320) (clinicaltrials.gov)
    P1, N=120, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Apr 2026 --> Jan 2027 | Trial primary completion date: Apr 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    ATM (ATM serine/threonine kinase) • ARID1A (AT-rich interaction domain 1A)
    |
    ARID1A mutation
    |
    Bavencio (avelumab) • tuvusertib (M1774) • lartesertib (M4076)
    13d
    Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322) (clinicaltrials.gov)
    P1/2, N=61, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • tuvusertib (M1774)
    28d
    Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jan 2027 | Trial primary completion date: Jun 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    tuvusertib (M1774)
    1m
    DDRiver Solid Tumours 301: Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) (clinicaltrials.gov)
    P1, N=161, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2027 --> Jul 2026 | Trial primary completion date: Jan 2027 --> Jul 2026
    Trial completion date • Trial primary completion date • First-in-human
    |
    ARID1A (AT-rich interaction domain 1A) • ATRX (ATRX Chromatin Remodeler)
    |
    ATM mutation • ARID1A mutation
    |
    Zejula (niraparib) • tuvusertib (M1774)
    2ms
    Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303) (clinicaltrials.gov)
    P1, N=12, Completed, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed
    Trial completion
    |
    tuvusertib (M1774)
    4ms
    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)
    4ms
    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)
    4ms
    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)
    4ms
    Comparing and combining xevinapant with ATR and PARP inhibition for the radiosensitization of HPV-negative HNSCC cells. (PubMed, Sci Rep)
    Both tuvusertib and olaparib induced stronger radiosensitization than xevinapant and combining both agents resulted in especially profound radiosensitization in three out of the four cell lines tested, whereas their combination with xevinapant or the combination of xevinapant with cisplatin was less effective. Assessment of cell death induction via annexin V/DAPI staining failed to generally predict cytotoxicity or radiosensitization of these approaches. Overall, our data are in line with the recent failure of the phase 3 TrilynX trial and suggest further investigation of ATR and PARP inhibition for the curative treatment of HPV-negative HNSCC.
    Clinical • Journal
    |
    ANXA5 (Annexin A5)
    |
    Lynparza (olaparib) • cisplatin • tuvusertib (M1774) • xevinapant (Debio 1143)
    4ms
    DDRiver Solid Tumours 301: Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) (clinicaltrials.gov)
    P1, N=161, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    ARID1A (AT-rich interaction domain 1A) • ATRX (ATRX Chromatin Remodeler)
    |
    ATM mutation • ARID1A mutation
    |
    Zejula (niraparib) • tuvusertib (M1774)
    5ms
    POP-ART: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=10, Terminated, Institut Curie | N=92 --> 10 | Trial completion date: Sep 2029 --> Nov 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2028 --> Nov 2025; Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    PLX038 • tuvusertib (M1774)