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    DRUG:

    givastomig (TJ-CD4B)

    i
    Other names: TJ-CD4B, ABL111, TJ-CLDN4B, TJ033721, ABL 111, TJ 033721, TJ CD4B, TJ CLDN4B, ABL-111, TJ-033721, TJCD4B, TJCLDN4B
    Company:
    ABL Bio, I-Mab
    Drug class:
    CLDN18.2 inhibitor, CD137 agonist
    Related drugs:
    5ms
    Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=168, Recruiting, I-Mab Biopharma US Limited | N=102 --> 168 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    Opdivo (nivolumab) • givastomig (TJ-CD4B)
    1year
    Givastomig, a novel Claudin18.2/4–1BB bispecific antibody, exerts bystander tumor-killing and synergistic anti-tumor activity with therapeutics in 1L/2L treatment for gastric cancer (SITC 2023)
    In addition, givastomig-mediated T cell activation and tumor-killing was enhanced in combination with chemotherapies used in 1L or 2L treatment for gastric cancer, including 5-fluorouracil plus oxaliplatin (FOLFOX) and paclitaxel...2 expression (25–50% of 2+), a triple-combination of givastomig, nivolumab and FOLFOX resulted in better tumor growth inhibition (TGI=40%), accompanied by an increase in tumor-infiltrating T cells, compared to nivolumab plus FOLFOX (TGI=8%)...2 expression. The synergistic anti-tumor activity by givastomig in combination with current therapeutics in 1L/2L treatment for gastric cancer, as demonstrated in preclinical studies, warrants further investigation of these combinations in clinics.
    PD(L)-1 Biomarker
    |
    CLDN18 (Claudin 18) • IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • paclitaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • givastomig (TJ-CD4B)
    over1year
    First-in-human phase I study of givastomig, a novel Claudin 18.2/4-1BB bispecific antibody in advanced solid tumors (ESMO 2023)
    The PK profile, s4-1BB induction, and efficacy signal support 12 mg/kg as an optimal dose. Further development of givastomig mono- and combo- therapy in GEC and other cancers is planned.
    P1 data • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    givastomig (TJ-CD4B)
    over1year
    CLDN18.2 and 4-1BB bispecific antibody givastomig exerts antitumor activity through CLDN18.2-expressing tumor-directed T-cell activation. (PubMed, J Immunother Cancer)
    Givastomig/ABL111 is a novel CLDN18.2×4-1BB bispecific antibody which has the potential to treat patients with gastric cancer with a wide range of CLDN18.2 expression level through the restricted activation of 4-1BB T cells in tumor microenvironment to avoid the risk of liver toxicity and systemic immune response.
    Journal • IO biomarker
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CLDN18.2 expression
    |
    givastomig (TJ-CD4B)
    over1year
    Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=102, Recruiting, I-Mab Biopharma Co. Ltd. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    givastomig (TJ-CD4B)
    3years
    TJ-CD4B (ABL111), a Claudin18.2-targeted 4-1BB tumor engager induces potent tumor-dependent immune response without dose-limiting toxicity in preclinical studies (SITC 2021)
    TJ-CD4B did not induce systemic immune response nor hepatic toxicity due to the CLDN18.2 dependent 4-1BB stimulation. These data warrant the current clinical development in phase I trial to validate the safety properties and tumor specific responses.
    Preclinical • IO biomarker
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    CLDN18.2 expression
    |
    givastomig (TJ-CD4B)
    over3years
    Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=108, Recruiting, I-Mab Biopharma Co. Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    givastomig (TJ-CD4B)
    over3years
    Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=108, Not yet recruiting, I-Mab Biopharma Co. Ltd.
    Clinical • New P1 trial
    |
    CLDN18 (Claudin 18)
    |
    givastomig (TJ-CD4B)