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    DRUG:

    IBI-343

    i
    Other names: IBI-343, IBI343
    Company:
    Innovent Biologics
    Drug class:
    Topoisomerase I inhibitor, CLDN18.2-targeted antibody-drug conjugate
    Related drugs:
    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
    Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med)
    The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CLDN1 (Claudin 1)
    |
    Vyloy (zolbetuximab-clzb) • AZD0901 • ALE.C04 • osemitamab (TST001) • IBI-343
    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
    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
    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
    12ms
    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
    2years
    A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=210, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CLDN18 (Claudin 18)
    |
    IBI-343
    over2years
    A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=210, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1 trial
    |
    CLDN18 (Claudin 18)
    |
    IBI-343