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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    9d
    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, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • docetaxel • irinotecan
    9d
    IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P2, N=389, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    gemcitabine • albumin-bound paclitaxel • arcotatug tavatecan (TAK-921)
    10d
    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, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • arcotatug tavatecan (TAK-921)
    16d
    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=592, 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)
    17d
    SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • SKB315
    22d
    SOT102, a novel CLDN18.2-targeting antibody-drug conjugate, exhibits strong therapeutic potential in solid tumors. (PubMed, BMC Cancer)
    SOT102 exhibited strong antitumor activity in preclinical models of CLDN18.2-positive cancers and demonstrated a favorable pharmacokinetic and safety profile in non-human primates. These data were used to support clinical evaluation of SOT102 as a potential treatment option for patients with CLDN18.2-expressing solid tumors.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive
    |
    SOT102
    24d
    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, Recruiting, Dong-A ST Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> May 2026
    Enrollment open • Trial initiation date • First-in-human
    |
    CLDN18 (Claudin 18)
    1m
    A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001) (clinicaltrials.gov)
    P3, N=464, Active, not recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    paclitaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • arcotatug tavatecan (TAK-921)
    1m
    GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 positive • HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    1m
    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, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    2ms
    GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 positive • HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    2ms
    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