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    DRUG CLASS:

    CLDN18.2-targeted antibody-drug conjugate

    Related drugs:
    1m
    SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=524, Not yet recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    paclitaxel • docetaxel • irinotecan • SHR-A1904
    1m
    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. | N=210 --> 470 | Trial completion date: Oct 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    IBI-343
    2ms
    The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=50, Recruiting, Shanghai Zhongshan Hospital
    New P2 trial • Combination therapy • Metastases
    |
    capecitabine • Kaitanni (cadonilimab) • BMS-986476
    3ms
    CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors. (PubMed, Cell Rep Med)
    CMG901's favorable preclinical profile supports its entry into the human clinical study. CMG901 is currently under phase 3 investigation in patients with advanced gastric/gastroesophageal junction adenocarcinoma expressing Claudin18.2 (NCT06346392).
    Journal
    |
    CLDN18 (Claudin 18)
    |
    AZD0901
    3ms
    Enhancing antitumor efficacy of CLDN18.2-directed antibody-drug conjugates through autophagy inhibition in gastric cancer. (PubMed, Cell Death Discov)
    Inhibiting autophagy by autophagy inhibitor LY294002 remarkably enhanced αCLDN18.2-MMAE-induced cytotoxicity and caspase-mediated apoptosis, indicating the cytoprotective role of autophagy in CLDN18.2-directed ADC-treated gastric cancer cells...Besides, the Akt/mTOR pathway inactivation was demonstrated to be implicated in the autophagy initiation in αCLDN18.2-MMAE-treated gastric cancer cells. In conclusion, our study highlighted a groundbreaking investigation into the mechanism of the CLDN18.2-directed ADC, focusing on the crucial role of autophagy, providing a novel insight to treat gastric cancer by the combination of CLDN18.2-directed ADC and autophagy inhibitor.
    Journal • PARP Biomarker
    |
    CLDN18 (Claudin 18) • CASP9 (Caspase 9)
    |
    CLDN18.2 positive • CLDN18.2 overexpression • CLDN1 overexpression
    |
    LY294002
    3ms
    MK-1200-002: Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=304, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    SKB315
    3ms
    Targeting Claudin-18.2 for cancer therapy: updates from 2024 ASCO annual meeting. (PubMed, J Hematol Oncol)
    At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, the final results of the phase 3 SPOTLIGHT trial were presented, demonstrating a significant survival benefit from the addition of the CLDN18.2-specific antibody zolbetuximab to chemotherapy in the first-line treatment of advanced gastroesophageal adenocarcinomas with ≥ 75% CLDN18.2 expression...In addition, several early-phase trials presented at ASCO 2024 investigate other CLDN18.2-targeting approaches in CLDN18.2-positive refractory advanced solid tumors, including the CLDN18.2-targeting antibody-drug conjugates LM-302 and IBI343, the bispecific anti-CLDN18.2/CD3 antibody IBI38, and the chimeric antigen receptor T cell therapy satricabtagene autoleucel. These novel approaches could potentially expand the benefit of CLDN18.2-targeting therapies to a broader range of tumor types and to tumors expressing lower levels of CLDN18.2.
    Review • Journal
    |
    CLDN18 (Claudin 18)
    |
    Vyloy (zolbetuximab-clzb) • satricabtagene autoleucel (CT041) • IBI-343
    4ms
    G-HOPE-001: 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 (clinicaltrials.gov)
    P3, N=450, Enrolling by invitation, Innovent Biologics (Suzhou) Co. Ltd. | Trial primary completion date: Jun 2027 --> Dec 2026
    Trial primary completion date • Metastases
    |
    paclitaxel • irinotecan • IBI-343
    4ms
    G-HOPE-001: 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 (clinicaltrials.gov)
    P3, N=450, Enrolling by invitation, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Enrolling by invitation | Trial completion date: Jun 2027 --> Dec 2027 | Initiation date: Mar 2024 --> Jun 2024 | Trial primary completion date: May 2026 --> Jun 2027
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    paclitaxel • irinotecan • IBI-343
    5ms
    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. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    AiTan (rivoceranib) • irinotecan • BMS-986476
    6ms
    BL-M05D1-101: A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    6ms
    CLAUDIO-01: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=160, Recruiting, SOTIO Biotech a.s. | Suspended --> Recruiting | N=269 --> 160 | Trial completion date: Jun 2025 --> Jun 2028 | Trial primary completion date: Dec 2023 --> Dec 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    SOT102
    7ms
    SHR-A1904-301: SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=924, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    capecitabine • oxaliplatin • Ariely (adebrelimab) • SHR-A1904
    7ms
    Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=206, Active, not recruiting, LaNova Medicines Zhejiang Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    CLDN18 (Claudin 18)
    |
    BMS-986476
    7ms
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1, N=17, Completed, Turning Point Therapeutics, Inc. | Active, not recruiting --> Completed | N=42 --> 17
    Trial completion • Enrollment change • Metastases
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    BMS-986476
    8ms
    Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=304, Recruiting, Merck Sharp & Dohme LLC | Phase classification: P2 --> P1/2 | Trial completion date: Mar 2027 --> Jan 2026 | Trial primary completion date: Jan 2027 --> Jan 2026
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    SKB315
    8ms
    SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=924, Not yet recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd.
    New P1 trial • Metastases
    |
    capecitabine • oxaliplatin • SHR-A1904 • SHR-A1912
    8ms
    A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial • Metastases
    8ms
    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=589, Recruiting, AstraZeneca
    New P3 trial
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • AZD0901
    8ms
    Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Harbin Medical University
    New P2 trial • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-343
    9ms
    Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=304, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    SKB315
    9ms
    A Study of RC118 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=135, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN1 positive
    |
    RC118
    9ms
    G-HOPE-001: 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 (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P3 trial • Metastases
    |
    paclitaxel • irinotecan • IBI-343
    9ms
    Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=304, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial • Metastases
    |
    SKB315
    10ms
    AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov)
    P2, N=123, Recruiting, AstraZeneca
    New P2 trial • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • AZD0901 • Onivyde (nanoliposomal irinotecan)
    11ms
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=20, Terminated, LaNova Australia Pty Limited | N=50 --> 20 | Trial completion date: May 2024 --> Nov 2023 | Recruiting --> Terminated; Sponsor's decision
    Enrollment change • Trial completion date • Trial termination • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • BMS-986476
    12ms
    A phase I study of EO-3021 in adult patients with solid tumors likely to express CLDN18.2. (ASCO-GI 2024)
    41, 2023. Clinical trial information: NCT05980416.
    Clinical • P1 data
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    EO-3021
    12ms
    Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-drug Conjugate for Treatment of CLDN18.2 Positive Cancers. (PubMed, Mol Cancer Ther)
    These data support clinical development of the CLDN18.2-307-mAb and CLDN18.2-307-ADC for treatment of CLDN18.2+ cancers. Both are now being investigated in phase 1 clinical studies.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    12ms
    CLAUDIO-01: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=269, Suspended, Sotio Biotech Inc. | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    HER-2 overexpression • HER-2 negative • CLDN18.2 expression
    |
    SOT102
    almost1year
    Safety, tolerability and efficacy of IBI343 in combination with sintilimab in subjects with advanced gastric/gastro- Esophageal junction adenocarcinoma: A Phase II study (ChiCTR2300077564 )
    P2, N=25, Not yet recruiting, First Affiliated Hospital of Anhui Medical University
    New P2 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • CLDN18.2 expression • CLDN18.2 positive
    |
    Tyvyt (sintilimab) • IBI-343
    1year
    Optimism Surrounds Claudin 18.2 ADC. (PubMed, Cancer Discov)
    Historically, progression-free survival (PFS) hovers around 7 months and overall survival (OS) around 14 to 16 months. However, depending on the dose, PFS with CMG901 ranged from 3.3 to 14.5 months, and OS ranged from 8.5 months to not reached, after a median follow up of 6 months.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    AZD0901
    1year
    A phase 1 trial of claudin 18.2-specific antibody-drug conjugate CMG901 in patients with advanced gastric/gastroesophageal junction cancer (ASCO Plenary Nov 2023)
    NCT04805307
    Clinical • P1 data • Metastases
    |
    CLDN18 (Claudin 18)
    |
    AZD0901
    1year
    Systematic Characterization of Antibody-Drug Conjugate Targets in Central Nervous System Tumors. (PubMed, Neuro Oncol)
    CNS tumors exhibit subtype-specific expression of ADC targets including several FDA-approved for other indications. Clinical trials of ADCs in CNS tumors may therefore be warranted.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CLDN18 (Claudin 18) • CD276 (CD276 Molecule) • CLDN6 (Claudin 6) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 expression • ERBB3 expression • TROP2 expression • CLDN6 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1year
    Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=206, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Enrolling by invitation --> Recruiting | N=128 --> 206
    Enrollment status • Enrollment change • Metastases
    |
    CLDN18 (Claudin 18)
    |
    BMS-986476
    1year
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=50, Recruiting, LaNova Australia Pty Limited | Enrolling by invitation --> Recruiting | Trial primary completion date: Oct 2023 --> Feb 2024
    Enrollment status • Trial primary completion date • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • BMS-986476
    1year
    A LM-302 Combined With Toripalimab Phase II Study (clinicaltrials.gov)
    P2, N=276, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Loqtorzi (toripalimab-tpzi) • BMS-986476
    1year
    A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=64, Recruiting, RemeGen Co., Ltd.
    New P1/2 trial • Combination therapy • IO biomarker • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN1 positive
    |
    Loqtorzi (toripalimab-tpzi) • RC118
    1year
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Turning Point Therapeutics, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | Trial completion date: Aug 2024 --> Jan 2024 | Trial primary completion date: Aug 2024 --> Jan 2024
    Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    BMS-986476
    1year
    CLINCH: A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=156, Recruiting, Antengene Biologics Limited | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CLDN18 (Claudin 18)
    |
    ATG-022
    1year
    Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers (clinicaltrials.gov)
    P1, N=0, Withdrawn, Conjupro Biotherapeutics, Inc. | N=72 --> 0 | Trial completion date: Mar 2025 --> Nov 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Feb 2025 --> Nov 2022
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN1 positive
    |
    EO-3021
    over1year
    Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2 (clinicaltrials.gov)
    P1, N=120, Recruiting, Elevation Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    EO-3021