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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    2d
    Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov)
    P3, N=752, Not yet recruiting, Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
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    HER-2 negative • HER-2 expression • CLDN18.2 positive • CLDN1 positive
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    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • tecotabart vedotin (LM-302)
    15d
    JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (clinicaltrials.gov)
    P3, N=560, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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    HER-2 negative
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    paclitaxel • docetaxel • irinotecan
    24d
    First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer (clinicaltrials.gov)
    P1, N=163, Active, not recruiting, TORL Biotherapeutics, LLC | Recruiting --> Active, not recruiting | N=70 --> 163 | Trial primary completion date: Feb 2026 --> Jun 2026
    Enrollment closed • Enrollment change • Trial primary completion date • First-in-human
    28d
    CLINCH-2: Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=132, Not yet recruiting, Antengene Biologics Limited
    New P1/2 trial
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    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
    30d
    A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients (clinicaltrials.gov)
    P1, N=156, Recruiting, Shanghai Institute Of Biological Products | Not yet recruiting --> Recruiting
    Enrollment open
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    CLDN18 (Claudin 18)
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    CLDN18.2 positive
    2ms
    JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (clinicaltrials.gov)
    P3, N=560, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P3 trial
    |
    paclitaxel • docetaxel • irinotecan
    3ms
    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 | Trial completion date: Apr 2027 --> Sep 2026 | Trial primary completion date: Oct 2026 --> May 2026
    Trial completion date • Trial primary completion date
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    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    3ms
    SKB315-I-01: A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=246, Recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Feb 2026 --> Jun 2028 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
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    CLDN18 (Claudin 18)
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    capecitabine • Cotelet (tagitanlimab) • SKB315
    3ms
    CIBI343A101: A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=470, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Jun 2027
    Trial completion date • Trial primary completion date • IO biomarker • First-in-human
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    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
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    5-fluorouracil • irinotecan • leucovorin calcium • arcotatug tavatecan (IBI-343)
    4ms
    Comparative analysis of the efficacy and safety of antibody‑drug conjugates, radionuclide‑drug conjugates and their combination targeting claudin 18.2 in gastric cancer treatment. (PubMed, Oncol Rep)
    In an NUGC‑4‑CLDN18.2 xenograft tumor model, the antitumor efficacy and toxicity of the mAb (SYSA1801mAb), as well as the ADC (SYSA1801) and RDC ([177Lu]Lu‑DOTA‑SYSA1801mAb), and their combinations in different sequences (ADC→RDC and RDC→ADC), were systematically assessed...Furthermore, sequential combination therapy that starts with ADC appears to be more favorable than approaches that start with RDC. Although ADC→RDC sequential therapy did not significantly outperform ADC monotherapy in this model, it may serve as an effective subsequent treatment strategy.
    Clinical • Journal
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    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
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    EO-3021
    4ms
    Tecotabart vedotin in Claudin 18.2-positive advanced gastric/gastroesophageal junction cancer: A Bayesian phase 1/2 clinical trial. (PubMed, Eur J Cancer)
    Tecotabart vedotin demonstrated encouraging anti-tumor activity and manageable safety in CLDN18.2-positive G/GEJ cancer, supporting further clinical development in gastrointestinal malignancies.
    Clinical • P1/2 data • Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    tecotabart vedotin (LM-302)
    4ms
    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, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    sonesitatug vedotin (AZD0901)