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    DRUG:

    tuvusertib (M1774)

    i
    Other names: M1774, M 1774, MSC2584415A, VXc-400, VR 1363004, M-1774, MSC 2584415A, VR1363004, VXc 400, MSC-2584415A, VR-1363004, VXc400, VRT-1363004, VRT1363004, VRT 1363004
    Company:
    EMD Serono
    Drug class:
    ATR inhibitor
    Related drugs:
    2ms
    Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303) (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    tuvusertib (M1774)
    2ms
    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. | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition • IO biomarker
    |
    Bavencio (avelumab) • tuvusertib (M1774) • lartesertib (M4076)
    2ms
    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. | Recruiting --> Active, not recruiting | N=130 --> 63
    Enrollment closed • Enrollment change
    |
    Zejula (niraparib) • tuvusertib (M1774) • lartesertib (M4076)
    4ms
    Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib. (PubMed, Clin Pharmacol Ther)
    The analysis supports tuvusertib 180 mg QD 2w on/1w off as the RDE and 100 mg QD as the no-regret dose for clinical evaluation. This example underscores the value of integrated quantitative pharmacology analyses to inform dose selection using a totality of evidence approach.
    PK/PD data • Journal
    |
    ARID1A (AT-rich interaction domain 1A)
    |
    ARID1A mutation
    |
    tuvusertib (M1774)
    4ms
    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) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    tuvusertib (M1774)
    4ms
    M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (clinicaltrials.gov)
    P1, N=141, Recruiting, EMD Serono Research & Development Institute, Inc. | N=96 --> 141 | Trial completion date: Mar 2026 --> Feb 2027 | Trial primary completion date: Mar 2026 --> Feb 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    abiraterone acetate • prednisone • tuvusertib (M1774) • M9466 • prednisolone
    5ms
    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 primary completion date: May 2025 --> Mar 2026
    Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • tuvusertib (M1774)
    5ms
    Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) (clinicaltrials.gov)
    P2, N=130, Recruiting, EMD Serono Research & Development Institute, Inc. | N=60 --> 130
    Enrollment change
    |
    Zejula (niraparib) • tuvusertib (M1774) • lartesertib (M4076)
    5ms
    Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303) (clinicaltrials.gov)
    P1, N=12, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Trial completion date: Nov 2025 --> Mar 2026 | Trial primary completion date: Nov 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    tuvusertib (M1774)
    7ms
    Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320) (clinicaltrials.gov)
    P1, N=123, Recruiting, EMD Serono Research & Development Institute, Inc. | N=72 --> 123
    Enrollment change • Checkpoint inhibition • IO biomarker
    |
    Bavencio (avelumab) • tuvusertib (M1774) • lartesertib (M4076)
    7ms
    Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer (clinicaltrials.gov)
    P2, N=20, Suspended, National Cancer Institute (NCI) | Trial completion date: May 2025 --> Jun 2026 | Trial primary completion date: May 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    tuvusertib (M1774)
    7ms
    Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer (clinicaltrials.gov)
    P2, N=20, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    tuvusertib (M1774)