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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    15d
    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
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    17d
    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
    |
    CLDN18 (Claudin 18)
    |
    capecitabine • SKB315 • tagitanlimab (HBM9167)
    24d
    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
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    5-fluorouracil • irinotecan • leucovorin calcium • arcotatug tavatecan (IBI-343)
    1m
    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
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    EO-3021
    2ms
    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)
    2ms
    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)
    2ms
    IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=64, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Jan 2025 --> Apr 2025
    Enrollment open • Trial initiation date
    |
    gemcitabine • albumin-bound paclitaxel • arcotatug tavatecan (IBI-343)
    3ms
    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 primary completion date: Sep 2026 --> Dec 2026
    Trial primary completion date
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    3ms
    A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study (clinicaltrials.gov)
    P2, N=276, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Trial completion date: Jan 2026 --> Jul 2028 | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Opdivo (nivolumab) • gemcitabine • Loqtorzi (toripalimab-tpzi) • AiTan (rivoceranib) • capecitabine • Teysuno (gimeracil/oteracil/tegafur) • tecotabart vedotin (LM-302)
    3ms
    LM302-01-102: Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=153, Completed, LaNova Medicines Zhejiang Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Jan 2025
    Trial completion • Trial completion date
    |
    CLDN18 (Claudin 18)
    |
    tecotabart vedotin (LM-302)
    3ms
    LM302-03-101: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov)
    P3, N=375, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Trial primary completion date: Aug 2026 --> Nov 2026
    Trial primary completion date
    |
    AiTan (rivoceranib) • irinotecan • tecotabart vedotin (LM-302)
    3ms
    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, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    sonesitatug vedotin (AZD0901)