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    DRUG:

    tecotabart vedotin (LM-302)

    i
    Other names: BMS 986476, LM 302, TPX 4589, BMS986476, TPX4589, LM-302, BMS-986476, TPX-4589, (LM)-302, LM302, LM-102-MMAE
    Company:
    Sino Biopharm
    Drug class:
    Microtubule inhibitor, CLDN18.2-targeted antibody-drug conjugate
    Related drugs:
    1m
    Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med)
    Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CDH6 (Cadherin 6) • CDH17 (Cadherin 17)
    |
    CLDN18.2 positive
    |
    Padcev (enfortumab vedotin-ejfv) • sonesitatug vedotin (AZD0901) • tecotabart vedotin (LM-302) • zelenectide pevedotin (BT8009) • SHR-A2102 • arcotatug tavatecan (IBI-343) • bulumtatug fuvedotin (9MW2821) • garetatug rezetecan (SHR-A1904) • raludotatug deruxtecan (DS-6000)
    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)
    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)
    10ms
    Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=20, Completed, LaNova Australia Pty Limited | Terminated --> Completed
    Trial completion
    |
    CLDN18 (Claudin 18)
    |
    Loqtorzi (toripalimab-tpzi) • tecotabart vedotin (LM-302)
    1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    2years
    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)