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    DRUG:

    mRNA-4359

    i
    Other names: mRNA-4359, mRNA4359, mRNA 4359
    Associations

    News

    Trials
    Company:
    Moderna
    Drug class:
    PD-L1 inhibitor, Immunostimulant, IDO inhibitor
    Related drugs:
    Associations

    News

    Trials
    6d
    Immunostimulatory and Immunodynamic Modeling Analysis to Determine a Plausible Starting Dose of mRNA-4359 for Use in First-In-Human Trials. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    An ongoing first-in-human (FIH) phase 1/2 clinical trial (NCT05533697) will evaluate the safety and antitumor activity of mRNA-4359 when administered alone and in combination with the anti-programmed death-1 agent pembrolizumab in participants with advanced solid tumors. Finally, the IS/ID modeling analysis determined that a 100 μg dose of mRNA-4359 would be the most appropriate starting dose for FIH trials. The described approach represents a unique application of IS/ID modeling to determine a therapeutically relevant FIH starting dose in the absence of supporting preclinical animal data.
    P1 data • Journal • First-in-human
    |
    IFNG (Interferon, gamma)
    |
    Keytruda (pembrolizumab) • mRNA-4359
    4ms
    Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=361, Recruiting, ModernaTX, Inc. | N=194 --> 361 | Trial completion date: Dec 2027 --> Feb 2032 | Trial primary completion date: Dec 2027 --> Feb 2032
    Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • mRNA-4359
    over3years
    Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=194, Recruiting, ModernaTX, Inc.
    New P1/2 trial • Combination therapy • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3)
    |
    Keytruda (pembrolizumab) • mRNA-4359