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    DRUG:

    fidasimtamab (IBI315)

    i
    Other names: IBI315, BH2950, BH-2950, IBI-315, BH 2950, IBI 315
    Associations

    News

    Trials
    Company:
    Hanmi, Innovent Biologics
    Drug class:
    PD1 inhibitor, HER2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1year
    Anti-PD-1/Her2 Bispecific Antibody IBI315 Enhances the Treatment Effect of Her2-Positive Gastric Cancer through Gasdermin B-Cleavage Induced Pyroptosis. (PubMed, Adv Sci (Weinh))
    Notably, GSDMB is found to be elevated in Her2-positive gastric cancer cells, providing a rationale for IBI315's efficacy. IBI315 is supported here as a promising bispecific antibody-based immunotherapy approach for Her2-positive gastric cancer in preclinical studies, broadening the therapeutic landscape of this patient population.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    IFNG (Interferon, gamma) • GSDMB (Gasdermin B)
    |
    HER-2 positive • EGFR positive • IFNG expression • GSDMB expression • HER-2 elevation • PD-1 positive
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    fidasimtamab (IBI315)
    1year
    A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor (clinicaltrials.gov)
    P1a/1b, N=55, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | N=191 --> 55 | Trial completion date: Dec 2025 --> Jun 2023
    Trial completion • Enrollment change • Trial completion date • Metastases
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 expression
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    fidasimtamab (IBI315)
    2years
    Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes (clinicaltrials.gov)
    P1/2; N=45; Not yet recruiting; Sponsor:Henan Cancer Hospital
    New P1/2 trial • IO biomarker
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    PD-L1 IHC 22C3 pharmDx
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    Focus V (anlotinib) • capecitabine • oxaliplatin • benmelstobart (APL-502) • osemitamab (TST001) • fidasimtamab (IBI315)