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    DRUG:

    ALE.C04

    i
    Other names: ALE.C04
    Company:
    Alentis Therap
    Drug class:
    CLDN1 inhibitor
    1year
    Study of ALE.C04 in Patients With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=21, Terminated, Alentis Therapeutics AG | N=160 --> 21 | Trial completion date: Feb 2028 --> Feb 2025 | Recruiting --> Terminated | Trial primary completion date: Feb 2028 --> Feb 2025; Reprioritization of Trial
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ALE.C04
    over1year
    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) • sonesitatug vedotin (AZD0901) • ALE.C04 • osemitamab (TST001) • arcotatug tavatecan (IBI-343)
    2years
    Study of ALE.C04 in Patients With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=220, Recruiting, Alentis Therapeutics AG
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ALE.C04
    over2years
    Study of ALE.C04 in Patients With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=220, Recruiting, Alentis Therapeutics AG | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ALE.C04
    over2years
    Study of ALE.C04 in Patients With Head and Neck Cancer (clinicaltrials.gov)
    P1/2, N=220, Not yet recruiting, Alentis Therapeutics AG
    New P1/2 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ALE.C04
    almost3years
    CLAUDIN-1 targeting antibody ALE.C04 drives single activity and restores anti-PD1 efficacy in solid tumors (AACR 2023)
    ALE.C04 perturbs the interface between CLDN1+ tumor cells and the stroma, thus restoring immune cell infiltration. Our pre-clinical data showed that: i) NJ-CLDN1 is a novel and druggable target in solid tumors ii) ALE.C04 is a selective anti-CLDN1 antibody capable of driving anti-tumor activity as both single agent and in combination with anti-PD1.
    Clinical • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    ALE.C04