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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    18h
    Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=160, Recruiting, SystImmune Inc. | N=120 --> 160
    Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • KRAS mutation • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation • IDH1 mutation • CLDN18.2 expression • FGFR2 mutation • FGFR2 fusion • IDH mutation + NTRK fusion • NTRK fusion
    7d
    A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=151, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
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    garetatug rezetecan (SHR-A1904)
    15d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 expression
    18d
    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
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
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    gemcitabine • albumin-bound paclitaxel • arcotatug tavatecan (TAK-921)
    19d
    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
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    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • arcotatug tavatecan (TAK-921)
    20d
    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)
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
    20d
    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
    |
    CLDN18 (Claudin 18)
    21d
    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)
    28d
    A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=191, Not yet recruiting, LigaChem Biosciences, Inc.
    New P1/2 trial • First-in-human
    |
    CLDN18 (Claudin 18)
    1m
    Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) (clinicaltrials.gov)
    P1/2, N=13, Completed, Merck Sharp & Dohme LLC | N=304 --> 13
    Enrollment change
    |
    SKB315
    1m
    A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=151, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P2 trial
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    garetatug rezetecan (SHR-A1904)
    1m
    Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=2130, Recruiting, AstraZeneca
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • CLDN18.2 expression • PD-L1 negative • CLDN18.2 positive • CLDN1 positive
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb) • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)