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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    7d
    A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 expression
    7d
    CLARITY-Gastric 01: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=572, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    7d
    CLINCH: A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=156, Recruiting, Antengene Biologics Limited | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    ATG-022
    8d
    CLINCH-2: A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=132, Recruiting, Antengene Biologics Limited | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative
    |
    Keytruda (pembrolizumab) • capecitabine • oxaliplatin • ATG-022
    13d
    A Phase II Clinical Study of SHR-A1904 Monotherapy in Second-Line or Later Treatment of Advanced Neuroendocrine Carcinoma (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Beijing GoBroad Hospital
    New P2 trial
    |
    garetatug rezetecan (SHR-A1904)
    14d
    A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment (clinicaltrials.gov)
    P3, N=438, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    paclitaxel • docetaxel • irinotecan
    16d
    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
    |
    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
    22d
    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
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    garetatug rezetecan (SHR-A1904)
    30d
    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
    1m
    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
    |
    gemcitabine • albumin-bound paclitaxel • arcotatug tavatecan (TAK-921)
    1m
    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)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • arcotatug tavatecan (TAK-921)
    1m
    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)