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    DRUG:

    emunkitug (HFB200301)

    i
    Other names: HFB200301, HFB2003
    Associations

    News

    Trials
    Company:
    HiFiBiO
    Drug class:
    TNFRSF1B agonist
    Related drugs:
    Associations

    News

    Trials
    3ms
    HFB-200301-01: A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, HiFiBiO Therapeutics | Recruiting --> Active, not recruiting | N=170 --> 72
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    Tevimbra (tislelizumab-jsgr) • emunkitug (HFB200301)
    2years
    A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=170, Recruiting, HiFiBiO Therapeutics | Phase classification: P1a/1b --> P1 | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    Tevimbra (tislelizumab-jsgr) • emunkitug (HFB200301)
    3years
    A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=170, Recruiting, HiFiBiO Therapeutics | Phase classification: P1 --> P1a/1b | N=90 --> 170 | Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    Tevimbra (tislelizumab-jsgr) • emunkitug (HFB200301)
    almost4years
    Phase I study of HFB200301, a first-in-class TNFR2 agonist monoclonal antibody in patients with solid tumors selected via Drug Intelligent Science (DIS). (ASCO 2022)
    Secondary objectives include pharmacokinetic parameters, preliminary evidence of anti-tumor efficacy (e.g., ORR, DCR, DOR) and pharmacodynamic evaluation (e.g., T cell subsets) in the blood and in the tumor. Furthermore, a potential predictive biomarker signature derived based on the DIS single-cell immune profiling approach will be investigated retrospectively.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    CD8-H
    |
    emunkitug (HFB200301)
    almost4years
    A Study of HFB200301 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=90, Recruiting, HiFiBiO Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    emunkitug (HFB200301)
    4years
    A Study of HFB200301 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=90, Not yet recruiting, HiFiBiO Therapeutics
    New P1 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    emunkitug (HFB200301)