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    GENE:

    CLDN18 (Claudin 18)

    i
    Other names: CLDN18, Claudin-18, Surfactant, Pulmonary Associated Protein J, Surfactant Associated 5, SFTA5, SFTPJ
    2d
    Systemic Therapy for Advanced Pancreatic Cancer in 2025: Current Standard-of-Care and Emerging Therapeutic Strategies. (PubMed, J Gastroenterol Hepatol)
    Emerging immunotherapies targeting Claudin18.2 and CXCR4 offer hope to overcome tumor resistance. Together, these strategies underscore the promise of molecular stratification, synthetic lethality, and novel targets to improve pancreatic cancer survival.
    Review • Journal • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • HRD (Homologous Recombination Deficiency) • CLDN18 (Claudin 18) • NRG1 (Neuregulin 1) • MTAP (Methylthioadenosine Phosphorylase) • CXCR4 (Chemokine (C-X-C motif) receptor 4)
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    HRD • KRAS wild-type • MTAP deletion • RAS wild-type • NRG1 fusion
    3d
    A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CLDN18 (Claudin 18)
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    HER-2 negative • CLDN18.2 expression
    6d
    IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P2, N=389, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P2 trial
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    CLDN18 (Claudin 18)
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    CLDN18.2 positive
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    gemcitabine • albumin-bound paclitaxel • arcotatug tavatecan (TAK-921)
    7d
    IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P2 trial
    |
    CLDN18 (Claudin 18)
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    CLDN18.2 expression
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    Tyvyt (sintilimab) • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • arcotatug tavatecan (TAK-921)
    8d
    DUAL-NK-PDAC: Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Beijing Biotech
    New P1/2 trial
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    CLDN18 (Claudin 18) • MSLN (Mesothelin)
    |
    CLDN18.2 positive
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    cyclophosphamide • fludarabine IV
    8d
    GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=163, Recruiting, AstraZeneca | N=240 --> 163 | Trial completion date: Sep 2027 --> May 2029 | Trial primary completion date: Jul 2026 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
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    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    9d
    A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=51, Not yet recruiting, Dong-A ST Co., Ltd.
    New P1 trial • First-in-human
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    CLDN18 (Claudin 18)
    9d
    GAMBIT: A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    sonesitatug vedotin (AZD0901)
    10d
    Zolbetuximab for gastroesophageal adenocarcinoma: drug review and lessons from the frontlines. (PubMed, Future Oncol)
    Real-world implementation of zolbetuximab is complicated by cumbersome administration times, short drug stability, extended observation time, and difficult tolerability. This report describes our experience in implementing zolbetuximab in clinical practice and provides an extensive drug evaluation.
    Review • Journal
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    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
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    Vyloy (zolbetuximab-clzb)
    10d
    First-line zolbetuximab plus mFOLFOX6 and nivolumab in unresectable CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. (PubMed, Nat Med)
    Efficacy and safety data support randomized evaluation of zolbetuximab plus chemoimmunotherapy in patients with CLDN18.2-positive and PD-L1-positive mG/GEJ adenocarcinoma in the ongoing phase 3 LUCERNA study. ClinicalTrials.gov: NCT03505320 .
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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    PD-L1 expression • HER-2 negative • CLDN18.2 positive • EGFR positive
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    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    10d
    Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers (clinicaltrials.gov)
    P1, N=10, Recruiting, Hainan Cancer Hospital
    New P1 trial
    |
    CLDN18 (Claudin 18)