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    5ms
    A Study of ZL-1211 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=162, Recruiting, Zai Biopharmaceutical (Suzhou) Co., Ltd.
    Trial completion date • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    ZL-1211
    1year
    Preliminary results of a phase 1/2, first-in-human, open-label, dose escalation study of ZL-1211 (anti-Claudin 18.2 mAb) in patients with unresectable or metastatic solid tumors. (ASCO 2023)
    ZL-1211 displayed an acceptable safety/tolerability profile to date and demonstrated preliminary antitumor effects. Clinical trial information: NCT05065710.
    Clinical • P1/2 data • Metastases
    |
    CLDN18 (Claudin 18)
    |
    ZL-1211
    1year
    ZL-1211 Exhibits Robust Antitumor Activity by Enhancing ADCC and Activating NK Cell-mediated Inflammation in CLDN18.2-High and -Low Expressing Gastric Cancer Models. (PubMed, Cancer Res Commun)
    ZL-1211, anti-CLDN18.2 therapeutic antibody can target CLDN18.2-high as well as -low gastric cancers that may not be eligible for treatment with clinical benchmark. ZL-1211 treatment induces NK-cell activation with robust inflammation to further activate antitumor immunity in tumor microenvironment.
    Preclinical • Journal
    |
    CLDN18 (Claudin 18) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    CLDN18.2 expression • CLDN18.2 underexpression
    |
    ZL-1211
    1year
    Clinical translation of biomarkers for ZL-1211, an anti-CLDN18.2 antibody, in patients with advanced solid tumors from a phase I dose-escalation study (AACR 2023)
    Taken together, analytical approaches developed and validated from preclinical studies were successfully translated to characterize clinical samples in the current Phase 1 trial. The exploratory analysis indicated the clinical relevance of multiple biomarkers and their potential as predictive biomarkers of ZL-1211.
    Clinical • P1 data • Metastases
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    CLDN18.2 positive • CD8 expression
    |
    ZL-1211
    over1year
    Anti-CLDN18.2 antibody ZL-1211 enhances anti-tumor activities in combination with chemotherapy in gastric cancer models (SITC 2022)
    Chemotherapy, such as gemcitabine, increased CLDN18.2 mRNA and protein expression levels in cancer cells and sensitized tumor cells to ZL-1211-mediated ADCC. Furthermore, ZL-1211 in combination with SoC chemotherapies, oxaliplatin + capecitabine (CAPOX), enhanced anti-tumor efficacy in SNU601 gastric cancer xenograft model...Conclusions These data provide rationale to combine ZL-1211 with SoC chemotherapy in gastric cancer. Currently, a phase I dose escalation study is underway to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of ZL-1211 in patients with advanced solid tumors ( NCT05065710 ).
    Preclinical • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 overexpression
    |
    gemcitabine • capecitabine • oxaliplatin • ZL-1211
    2years
    ZL-1211 exhibits robust anti-tumor activity by enhancing ADCC and activating innate and adaptive immunity in CLDN18.2-high and -low expressing gastric cancer models (AACR 2022)
    Taken together, our data suggest that ZL-1211 more effectively targets CLDN18.2-high gastric cancers as well as -low expressing malignancies that are not eligible for treatment with the leading clinical benchmark by inducing a robust ADCC response and activating innate and adaptive immunity to enhance anti-tumor efficacy. Clinical activity of ZL-1211 is currently under evaluation in a Phase I clinical trial (NCT05065710).
    Preclinical
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CLDN8 (Claudin 8)
    |
    CLDN18.2 expression • CLDN18.2 underexpression
    |
    ZL-1211
    over2years
    A Study of ZL-1211 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=162, Recruiting, Zai Biopharmaceutical (Suzhou) Co., Ltd. | Initiation date: Oct 2021 --> Jan 2022
    Trial initiation date
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    ZL-1211
    over2years
    A Study of ZL-1211 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=162, Recruiting, Zai Biopharmaceutical (Suzhou) Co., Ltd.
    Clinical • New P1/2 trial
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    ZL-1211