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    GENE:

    CLDN18 (Claudin 18)

    i
    Apply
    Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors (D9750C00001) (NCT06005493)
    Phase 1/2
    AstraZeneca
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    07/11/2023
    Primary completion :
    12/16/2026
    Completion :
    12/16/2026
    CLDN18
    |
    CLDN18.2 positive • CLDN1 positive
    |
    AZD5863
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (NCT05188664)
    Phase 1/2
    LaNova Australia Pty Limited
    Completed
    Last update posted :
    02/17/2025
    Initiation :
    05/10/2022
    Primary completion :
    11/14/2023
    Completion :
    11/14/2023
    CLDN18
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS (SHR-A1904-I-104) (NCT05277168)
    Phase 1/2
    Jiangsu HengRui Medicine Co., Ltd.
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    05/30/2022
    Primary completion :
    03/03/2026
    Completion :
    05/30/2026
    CLDN18
    |
    SHR-A1904
    TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) (NCT05862324)
    Phase 1/2
    Triumvira Immunologics, Inc.
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    08/23/2023
    Primary completion :
    08/01/2027
    Completion :
    08/01/2027
    EGFR • HER-2 • BRAF • ALK • CLDN18 • BRCA
    |
    EGFR mutation • BRAF mutation • HER-2 expression • CLDN18.2 positive • ALK translocation • BRCA mutation
    |
    albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • TAC101-Claudin18.2
    Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GEMINI-Gastric) (NCT05702229)
    Phase 2
    AstraZeneca
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    01/16/2023
    Primary completion :
    01/30/2026
    Completion :
    01/28/2027
    CLDN18
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901 (KYM901) (NCT04805307)
    Phase 1
    Keymed Biosciences Co.Ltd
    Completed
    Last update posted :
    02/12/2025
    Initiation :
    12/24/2020
    Primary completion :
    04/05/2024
    Completion :
    04/05/2024
    CLDN18
    |
    CLDN18.2 positive
    |
    sonesitatug vedotin (AZD0901)
    Spevatamig (PT886) for Treatment of Patients with Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (NCT05482893)
    Phase 1/2
    Phanes Therapeutics
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    03/15/2023
    Primary completion :
    12/01/2027
    Completion :
    04/01/2028
    CLDN18
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab) • gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • spevatamig (PT886)
    A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer (8951-CL-5201) (NCT03816163)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    01/31/2025
    Initiation :
    03/15/2019
    Primary completion :
    08/31/2026
    Completion :
    08/31/2026
    CLDN18
    |
    CLDN18.2 expression
    |
    gemcitabine • albumin-bound paclitaxel • Vyloy (zolbetuximab-clzb)
    A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors (NCT06038396)
    Phase 1/2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    08/03/2023
    Primary completion :
    02/28/2026
    Completion :
    08/31/2026
    CLDN18
    |
    CLDN1 positive
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin) • ciletatug vedotin (RC118)
    IBI343 Combined with Chemotherapy in Advanced Pancreatic Cancer (NCT06770439)
    Phase 2
    Zhejiang University
    Not yet recruiting
    Last update posted :
    01/13/2025
    Initiation :
    01/01/2025
    Primary completion :
    01/01/2027
    Completion :
    01/01/2028
    CLDN18
    |
    gemcitabine • albumin-bound paclitaxel • IBI-343
    Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer (NCT06767449)
    Phase N/A
    Yonsei University
    Recruiting
    Last update posted :
    01/09/2025
    Initiation :
    12/01/2024
    Primary completion :
    12/01/2026
    Completion :
    12/01/2026
    PD-L1 • CLDN18
    |
    PD-L1 expression
    |
    Vyloy (zolbetuximab-clzb)
    Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors (NCT04900818)
    Phase 1
    I-Mab Biopharma US Limited
    Recruiting
    Last update posted :
    01/03/2025
    Initiation :
    06/29/2021
    Primary completion :
    12/01/2025
    Completion :
    12/01/2026
    PD-L1 • CLDN18
    |
    CLDN18.2 positive
    |
    Opdivo (nivolumab) • givastomig (TJ-CD4B)
    A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (TranStar102) (NCT04495296)
    Phase 1/2
    Suzhou Transcenta Therapeutics Co., Ltd.
    Recruiting
    Last update posted :
    10/21/2024
    Initiation :
    08/13/2020
    Primary completion :
    02/25/2025
    Completion :
    05/01/2025
    HER-2 • CLDN18
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
    Phase IIT Trial of SNA014 (NCT06646783)
    Phase 1
    SmartNuclide Biopharma
    Not yet recruiting
    Last update posted :
    10/17/2024
    Initiation :
    10/20/2024
    Primary completion :
    10/20/2025
    Completion :
    11/20/2025
    CLDN18
    A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma (8951-CL-0104) (NCT03528629)
    Phase N/A
    Astellas Pharma Inc
    Completed
    Last update posted :
    06/14/2024
    Initiation :
    05/17/2018
    Primary completion :
    06/09/2020
    Completion :
    06/09/2020
    CLDN18
    |
    Vyloy (zolbetuximab-clzb)
    AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (CLARITY-PanTumor01) (NCT06219941)
    Phase 2
    AstraZeneca
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    12/13/2023
    Primary completion :
    05/02/2025
    Completion :
    01/19/2027
    CLDN18
    |
    CLDN18.2 expression
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) (NCT03504397)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    06/11/2024
    Initiation :
    06/21/2018
    Primary completion :
    09/09/2022
    Completion :
    03/31/2025
    HER-2 • CLDN18
    |
    HER-2 negative • CLDN18.2 expression
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer (NCT05911217)
    Phase 1
    CARsgen Therapeutics Co., Ltd.
    Recruiting
    Last update posted :
    05/27/2024
    Initiation :
    07/11/2023
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    CLDN18
    |
    CLDN18.2 positive
    |
    satricabtagene autoleucel (CT041)
    Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01) (NCT05525286)
    Phase 1/2
    SOTIO Biotech a.s.
    Recruiting
    Last update posted :
    05/27/2024
    Initiation :
    03/31/2022
    Primary completion :
    12/01/2027
    Completion :
    06/01/2028
    CLDN18
    |
    HER-2 overexpression • HER-2 negative • CLDN18.2 expression
    |
    SOT102
    Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors (NCT04400383)
    Phase 1
    CARsgen Therapeutics Co., Ltd.
    Completed
    Last update posted :
    05/24/2024
    Initiation :
    06/04/2020
    Primary completion :
    07/08/2023
    Completion :
    09/28/2023
    CLDN18
    |
    CLDN18.2 positive
    |
    capecitabine • oxaliplatin • AB011
    A Study of ZL-1211 in Patients With Advanced Solid Tumor (NCT05065710)
    Phase 1/2
    Zai Biopharmaceutical (Suzhou) Co., Ltd.
    Completed
    Last update posted :
    05/24/2024
    Initiation :
    01/19/2022
    Primary completion :
    03/09/2024
    Completion :
    04/09/2024
    CLDN18
    |
    CLDN18.2 positive
    |
    ZL-1211
    Early Access Program for Zolbetuximab (NCT06048081)
    Phase N/A
    Astellas Pharma Global Development, Inc.
    Available
    Last update posted :
    05/23/2024
    HER-2 • CLDN18
    |
    HER-2 negative
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW) (NCT03653507)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/28/2018
    Primary completion :
    10/25/2022
    Completion :
    03/31/2025
    HER-2 • CLDN18
    |
    HER-2 negative • CLDN18.2 expression
    |
    capecitabine • oxaliplatin • Vyloy (zolbetuximab-clzb)
    A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma (ILUSTRO) (NCT03505320)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Recruiting
    Last update posted :
    05/09/2024
    Initiation :
    06/29/2018
    Primary completion :
    04/30/2025
    Completion :
    12/31/2026
    PD-L1 • CLDN18
    |
    PD-L1 expression • HER-2 negative • CLDN18.2 expression • CLDN18.2 positive
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb)
    Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors. (CT041-CG4006) (NCT03874897)
    Phase 1
    Peking University
    Completed
    Last update posted :
    04/30/2024
    Initiation :
    03/26/2019
    Primary completion :
    03/20/2021
    Completion :
    01/26/2024
    CLDN18
    |
    Loqtorzi (toripalimab-tpzi) • cyclophosphamide • satricabtagene autoleucel (CT041)
    Study of LM-302 in Patients With Advance Solid Tumors (NCT05161390)
    Phase 1/2
    LaNova Medicines Zhejiang Co., Ltd.
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    11/26/2021
    Primary completion :
    03/10/2025
    Completion :
    06/08/2025
    CLDN18
    |
    tecotabart vedotin (LM-302)
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (NCT05001516)
    Phase 1
    Turning Point Therapeutics, Inc.
    Completed
    Last update posted :
    04/17/2024
    Initiation :
    12/29/2021
    Primary completion :
    01/04/2024
    Completion :
    01/04/2024
    MSI • CLDN18
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    tecotabart vedotin (LM-302)
    A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (CLINCH) (NCT05718895)
    Phase 1
    Antengene Biologics Limited
    Recruiting
    Last update posted :
    04/10/2024
    Initiation :
    03/27/2023
    Primary completion :
    06/30/2026
    Completion :
    06/30/2026
    CLDN18
    |
    ATG-022
    Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (NCT06321913)
    Phase 2
    Harbin Medical University
    Not yet recruiting
    Last update posted :
    03/20/2024
    Initiation :
    03/15/2024
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    CLDN18
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-343
    SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry (NCT03452774)
    Phase N/A
    Massive Bio, Inc.
    Recruiting
    Last update posted :
    03/15/2024
    Initiation :
    01/01/2018
    Primary completion :
    12/01/2026
    Completion :
    06/01/2027
    EGFR • HER-2 • PD-L1 • KRAS • BRAF • ER • ALK • TP53 • TMB • FLT3 • ABL1 • NRAS • BRCA1 • BRCA2 • FGFR2 • PTEN • ROS1 • IDH1 • NTRK1 • BCL2 • IDH2 • NTRK3 • NTRK2 • STK11 • NPM1 • HRAS • DNMT3A • ERBB3 • RB1 • CLDN18 • PDGFRA • NF1 • JAK2 • NRG1 • POLE • AKT1 • PD-1 • CCND1 • MCL1 • KDR • PBRM1 • BAP1 • VEGFA • BCL6 • PDGFRB • PTCH1 • FGFR4 • MSH6 • CDK4 • MSH2 • CTNNB1 • MAP2K2 • FBXW7 • WT1 • ATRX • BRCA • RAF1 • TSC2 • CHEK2 • PD-L2 • ERBB4 • JAK1 • FANCA • TSC1 • MDM4 • POLD1 • CDK6 • CEBPA • PARP1 • AURKA • JAK3 • RICTOR • CHEK1 • GATA6 • MSH3 • TGFBR2 • GNAS • MYCL • AKT2 • CCND2 • CCND3 • CSF1R • MAP3K1 • ERCC4 • HDAC1 • PRDM1 • ZNF217 • CDKN1A • GATA3 • PARP2 • PARP3 • SDHA • ACVR1B • ZNF703
    |
    HER-2 mutation • BAP1 mutation • AKT1 mutation • FGFR3 fusion • JAK3 mutation
    A Clinical Study of MIL93 in Solid Tumors. (NCT04671875)
    Phase 1
    Beijing Mabworks Biotech Co., Ltd.
    Recruiting
    Last update posted :
    03/13/2024
    Initiation :
    04/21/2021
    Primary completion :
    08/01/2025
    Completion :
    08/01/2025
    CLDN18
    |
    CLDN18.2 positive
    |
    MIL93
    Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma (LB1908-1001) (NCT05539430)
    Phase 1
    Legend Biotech USA Inc
    Recruiting
    Last update posted :
    03/11/2024
    Initiation :
    04/18/2023
    Primary completion :
    07/01/2025
    Completion :
    12/01/2025
    CLDN18
    |
    CLDN18.2 positive
    |
    LB1908
    Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection (NCT04581473)
    Phase 1/2
    CARsgen Therapeutics Co., Ltd.
    Recruiting
    Last update posted :
    03/06/2024
    Initiation :
    10/23/2020
    Primary completion :
    06/30/2024
    Completion :
    06/30/2038
    HER-2 • CLDN18
    |
    HER-2 expression • CLDN18.2 positive
    |
    paclitaxel • AiTan (rivoceranib) • irinotecan • satricabtagene autoleucel (CT041)
    Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression (NCT05472857)
    Phase 1
    Suzhou Immunofoco Biotechnology Co., Ltd
    Recruiting
    Last update posted :
    03/06/2024
    Initiation :
    08/08/2022
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    CLDN18
    |
    IMC002
    Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2 (NCT05980416)
    Phase 1
    Elevation Oncology
    Recruiting
    Last update posted :
    03/06/2024
    Initiation :
    08/10/2023
    Primary completion :
    09/01/2028
    Completion :
    12/01/2028
    CLDN18
    |
    CLDN18.2 expression
    |
    EO-3021
    A Study of RC118 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (NCT05205850)
    Phase 1/2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    02/20/2024
    Initiation :
    03/03/2022
    Primary completion :
    09/30/2025
    Completion :
    12/01/2025
    CLDN18
    |
    CLDN1 positive
    |
    ciletatug vedotin (RC118)
    A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors (NCT05639153)
    Phase 1
    Zhejiang Doer Biologics Co., Ltd.
    Recruiting
    Last update posted :
    01/25/2024
    Initiation :
    05/13/2022
    Primary completion :
    06/30/2024
    Completion :
    04/30/2025
    CLDN18
    |
    CLDN18.2 positive
    |
    DR30303
    Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors (NCT05981235)
    Phase 1
    Peking University
    Recruiting
    Last update posted :
    01/01/2024
    Initiation :
    12/14/2023
    Primary completion :
    06/01/2026
    Completion :
    11/01/2028
    CLDN18
    |
    CLDN18.2 expression
    |
    AZD6422
    Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies (NCT05164458)
    Phase 1
    Innovent Biologics (Suzhou) Co. Ltd.
    Recruiting
    Last update posted :
    12/28/2023
    Initiation :
    03/22/2022
    Primary completion :
    04/30/2024
    Completion :
    09/30/2024
    CLDN18
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-389
    Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers (ELIMYN18.2) (NCT04404595)
    Phase 1/2
    CARsgen Therapeutics Co., Ltd.
    Active, not recruiting
    Last update posted :
    12/19/2023
    Initiation :
    10/23/2020
    Primary completion :
    06/01/2025
    Completion :
    09/01/2035
    CLDN18
    |
    CLDN18.2 positive
    |
    satricabtagene autoleucel (CT041)