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    DRUG:

    verzistobart (INCAGN2390)

    i
    Other names: INCAGN2390, INCAGN 02390, INCAGN-2390, INCAGN02390, NCAGN-2390, INCAGN-02390, INCAGN 2390, NCAGN2390, NCAGN 2390
    Associations

    News

    Trials
    Company:
    Agenus, Incyte, Xoma
    Drug class:
    TIM-3 inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=61, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    4ms
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Trial completion date: Jun 2025 --> Jul 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    5ms
    First-in-human phase I open-label study of the anti-TIM-3 monoclonal antibody INCAGN02390 in patients with select advanced or metastatic solid tumors. (PubMed, Oncologist)
    In this heavily pretreated population, no DLTs were reported and modest efficacy was exhibited. A 400-mg Q2W dose was selected for phase II studies investigating INCAGN02390 as part of combination immunotherapies for advanced cancers.
    P1 data • Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    verzistobart (INCAGN2390)
    6ms
    POD1UM-204: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (clinicaltrials.gov)
    P2, N=206, Active, not recruiting, Incyte Corporation | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
    |
    PD-L1 expression • MSI-H/dMMR • FGFR mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    10ms
    TRICK-MCC: Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, University of Washington | N=20 --> 12 | Trial completion date: Dec 2029 --> Apr 2027 | Trial primary completion date: Dec 2029 --> Jan 2027 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    1year
    POD1UM-204: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (clinicaltrials.gov)
    P2, N=206, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=300 --> 206
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
    |
    PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over1year
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=0, Withdrawn, University of Alabama at Birmingham | N=18 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over1year
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: May 2024 --> Feb 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    almost2years
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, University of Alabama at Birmingham
    New P1 trial • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    almost2years
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Terminated, Incyte Corporation | Trial completion date: Jun 2024 --> Jan 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jan 2024; Business Decision. No safety concerns contributed to this decision.
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=61, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=146 --> 61
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=45 --> 30
    Enrollment closed • Enrollment change • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)