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    DRUG:

    caxmotabart entudotin (IKS014)

    i
    Other names: IKS014, LCB14, FS-1502
    Company:
    Fosun Pharma, Iksuda Therap, LigaChem Biosci
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    5d
    IKS014-01: IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov)
    P1, N=165, Recruiting, Iksuda Therapeutics Ltd. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 expression • HER-2 amplification + HR-positive
    |
    caxmotabart entudotin (IKS014)
    8ms
    FS-CY1502-Ph1-01: Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer. (clinicaltrials.gov)
    P1, N=161, Completed, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Active, not recruiting --> Completed | N=297 --> 161
    Trial completion • Enrollment change
    |
    HER-2 positive • HER-2 expression
    |
    caxmotabart entudotin (IKS014)
    11ms
    A multicenter, open-label, double-cohort, phase II study: to evaluate the efficacy and safety of FS-1502 in patients with HER2-overexpressing locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (ChiCTR2500101151)
    P2, N=79, Completed, Sir Run Run Shaw Hospital , Zhejiang University School of Medicine; Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    caxmotabart entudotin (IKS014)
    1year
    IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov)
    P1, N=165, Recruiting, Iksuda Therapeutics Ltd. | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 expression • HER-2 amplification + HR-positive
    |
    caxmotabart entudotin (IKS014)
    1year
    An open, two-cohort, multicenter Phase II study of FS-1502 in combination with Srulizumab and chemotherapy in patients with HER2-expressing advanced gastric cancer (ChiCTR2500099447)
    P2, N=58, Completed, Beijing Cancer Hospital; Shanghai Fosun Pharmaceutical (Group) Limited by Share Ltd
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • HER-2 positive • HER-2 expression
    |
    5-fluorouracil • capecitabine • caxmotabart entudotin (IKS014)
    2years
    Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer. (clinicaltrials.gov)
    P1, N=297, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2023 --> Apr 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    HER-2 positive • HER-2 expression
    |
    caxmotabart entudotin (IKS014)
    over2years
    Model-Informed Dose Selection for an Investigational HER2 ADC FS-1502 in Patients with HER2 Expressed Advanced Malignant Solid Tumors. (PubMed, Br J Clin Pharmacol)
    This PopPK and E-R analysis guided the recommended phase II dose (RP2D) selection of 2.3 mg/kg Q3W and supported body weight based dosing for an investigational HER2 ADC FS-1502.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    caxmotabart entudotin (IKS014)
    over2years
    IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov)
    P1, N=165, Recruiting, Iksuda Therapeutics Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 expression
    |
    caxmotabart entudotin (IKS014)
    over2years
    FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=314, Recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • caxmotabart entudotin (IKS014)
    almost3years
    IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov)
    P1, N=165, Not yet recruiting, Iksuda Therapeutics Ltd.
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 expression
    |
    caxmotabart entudotin (IKS014)
    3years
    FS-1502 in HER2-positive advanced breast cancer: Results from an open-label, phase 1 study. (ASCO 2023)
    All pts had previously received anti-HER2 therapy, among which trastuzumab ± pertuzumab (n = 67, 96%) and pyrotinib (n = 52, 74%) were the most common. FS-1502 demonstrated very promising antitumor activity and was well tolerated in heavily pretreated HER2-positive BC, with mild eye toxicity and no related interstitial lung disease reported. A Phase 3 clinical trial is under planning to further confirm efficacy and safety of FS-1502 in pts with advanced HER2-positive BC. Clinical trial information: NCT03944499.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • caxmotabart entudotin (IKS014)
    3years
    FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=314, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • caxmotabart entudotin (IKS014)