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    DRUG:

    tecotabart vedotin (LM-302)

    i
    Other names: LM-302, BMS-986476, TPX-4589, (LM)-302, LM302, LM-102-MMAE, BMS 986476, LM 302, TPX 4589, BMS986476, TPX4589
    Company:
    LaNova Medicines Limited
    Drug class:
    Microtubule inhibitor, CLDN18.2-targeted antibody-drug conjugate
    Related drugs:
    3ms
    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) • tecotabart vedotin (LM-302)
    6ms
    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 • tecotabart vedotin (LM-302)
    8ms
    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)
    |
    tecotabart vedotin (LM-302)
    8ms
    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
    |
    tecotabart vedotin (LM-302)
    1year
    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) • tecotabart vedotin (LM-302)
    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)
    |
    tecotabart vedotin (LM-302)
    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) • tecotabart vedotin (LM-302)
    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) • tecotabart vedotin (LM-302)
    over1year
    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
    |
    tecotabart vedotin (LM-302)
    over1year
    A LM-302 Combined With Toripalimab Phase II Study (clinicaltrials.gov)
    P2, N=276, Not yet recruiting, LaNova Medicines Zhejiang Co., Ltd.
    New P2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    over1year
    Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Turning Point Therapeutics, Inc. | Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: Apr 2023 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    tecotabart vedotin (LM-302)
    2years
    Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=128, Enrolling by invitation, LaNova Medicines Zhejiang Co., Ltd. | Recruiting --> Enrolling by invitation
    Enrollment status • Metastases
    |
    CLDN18 (Claudin 18)
    |
    tecotabart vedotin (LM-302)
    over2years
    Preclinical activity for TPX-4589 (LM-302), an antibody-drug conjugate targeting tight junction protein CLDN18.2 in solid tumors (AACR-NCI-EORTC 2022)
    In a CLDN18.2-high patient-derived xenograft (PDX) PC tumor model, increasing doses of TPX-4589 demonstrated superior tumor growth inhibition compared to gemcitabine and LM-102, a compound with identical anti-CLDN18.2 mAb component as LM-302, and similar efficacy to LM-102 + gemcitabine in combination. TPX-4589, a novel CLDN18.2-targeting ADC, showed potent inhibitory effects on tumor cell proliferation in vitro and reduced tumor volume in both high- and low-expressing CDLN18.2 tumor models, with superior internalization and efficacy to zolbetuximab in a GC tumor model. These data suggest that TPX-4589 is a promising therapeutic candidate that warrants further investigation in clinical studies.
    Preclinical
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN18.2 overexpression • CLDN18.2 underexpression
    |
    gemcitabine • Vyloy (zolbetuximab-clzb) • tecotabart vedotin (LM-302)
    over2years
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=50, Enrolling by invitation, LaNova Australia Pty Limited | Active, not recruiting --> Enrolling by invitation
    Enrollment open • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    over2years
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=50, Active, not recruiting, LaNova Australia Pty Limited | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    almost3years
    Study of LaNova Medicines(LM)-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, LaNova Medicines Limited | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18) • CLDN8 (Claudin 8)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    tecotabart vedotin (LM-302)
    almost3years
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, LaNova Australia Pty Limited
    Clinical • New P1/2 trial • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    almost3years
    Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=128, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18) • CLDN8 (Claudin 8)
    |
    tecotabart vedotin (LM-302)
    3years
    Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=128, Not yet recruiting, LaNova Medicines Zhejiang Co., Ltd.
    New P1/2 trial
    |
    CLDN18 (Claudin 18) • CLDN8 (Claudin 8)
    |
    tecotabart vedotin (LM-302)
    over3years
    Study of LaNova Medicines(LM)-302 in Patients With Advance Solid Tumors (clinicaltrials.gov)
    P1/2, N=42, Not yet recruiting, LaNova Medicines Limited
    Clinical • New P1/2 trial
    |
    MSI (Microsatellite instability) • CLDN18 (Claudin 18)
    |
    MSI-H/dMMR • CLDN18.2 expression • CLDN18.2 positive
    |
    tecotabart vedotin (LM-302)