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    DRUG:

    IMC-001

    i
    Other names: STI3031, STIA1015, IMC-001, STI-3031, IMC 001, STI-A1015, IMC001, STI 3031, STI A1015
    Associations

    News

    Trials
    Company:
    Immuneoncia Therap
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1d
    Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study (clinicaltrials.gov)
    P1, N=3, Terminated, Mayo Clinic | Trial completion date: Jan 2026 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2026 --> Feb 2025; low/slow accrual
    Trial completion date • Trial termination • Trial primary completion date
    |
    IMC-001
    3ms
    A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Atherosclerotic Plaques in Patients With ACS. (clinicaltrials.gov)
    P2, N=30, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=14 --> 30 | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Nov 2025 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    IMC-001 • timdarpacept (IMM01)
    6ms
    A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov)
    P2, N=30, Recruiting, ImmuneOncia Therapeutics Inc. | Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Aug 2029 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    IMC-001 • timdarpacept (IMM01)
    6ms
    A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov)
    P2, N=14, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IMC-001 • timdarpacept (IMM01)
    8ms
    NeoChance: Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, Asan Medical Center | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    IMC-001
    11ms
    A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov)
    P2, N=14, Not yet recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P2 trial
    |
    IMC-001 • timdarpacept (IMM01)
    11ms
    Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=0, Withdrawn, Mayo Clinic | N=40 --> 0 | Trial completion date: Nov 2025 --> Jul 2024 | Recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Jul 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    albumin-bound paclitaxel • IMC-001
    over1year
    A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, ImmuneOncia Therapeutics Inc.
    New P2 trial • Metastases
    |
    IMC-001
    over1year
    A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, ImmuneOncia Therapeutics Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Feb 2026 | Trial primary completion date: Dec 2023 --> Jul 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IMC-001
    almost2years
    Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study (clinicaltrials.gov)
    P1, N=3, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=18 --> 3
    Enrollment closed • Enrollment change
    |
    IMC-001
    over2years
    Balance of CD36+ and CD16+ monocytes controls TLR-mediated cytokine release syndrome and MHC-dependent antitumor responses in EpCAM CAR T cell therapy for gastrointestinal cancers (ESMO 2023)
    Clinical trial identification The study had a classic 3+3 design for each indication trial, with separate EpCAM CAR-T cell (IMC001) dose escalations for monotherapy...Conclusions We present valuable insights into the pathophysiology of CRS and suggest that TLR4 on CD36+ monocytes is a promising target for managing CRS, which offers a new strategy for mitigating the side effects of CAR-T therapy. We also highlight the role of innate immune components, particularly CD16+ monocytes, in achieving optimal CAR-T treatment efficacy through antigen processing and presentation.
    CAR T-Cell Therapy
    |
    CD36 (thrombospondin receptor) • EPCAM (Epithelial cell adhesion molecule) • TLR4 (Toll Like Receptor 4)
    |
    IMC-001
    over3years
    EpCAM-targeted CAR-T cell therapy in patients with advanced colorectal and gastric cancers (ESMO 2022)
    IMC001 shows a favorable safety profile and reasonable anti-tumor activities at the initial dosage level in patients with refractory EpCAM+ cancers of digestive system. Updated data from open cohorts will be presented.
    Clinical • CAR T-Cell Therapy
    |
    EPCAM (Epithelial cell adhesion molecule)
    |
    EPCAM expression
    |
    IMC-001 • IMC001