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    DRUG:

    raludotatug deruxtecan (DS-6000)

    i
    Other names: DS-6000, DS-6000a, R-DXd, MK-5909, RDXd, R DXd, DS6000, DS 6000, DS6000a, DS 6000a, MK5909, MK 5909
    Associations

    News

    Trials
    Company:
    Daiichi Sankyo, Merck (MSD)
    Drug class:
    Topoisomerase I inhibitor, CDH6-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    2ms
    A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Daiichi Sankyo
    New P2 trial
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    raludotatug deruxtecan (DS-6000)
    2ms
    REJOICE-Ovarian01: A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2/3, N=650, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed
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    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • raludotatug deruxtecan (DS-6000)
    2ms
    Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov)
    P1/2, N=110, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting | N=80 --> 110 | Trial completion date: Nov 2026 --> Nov 2029 | Trial primary completion date: Nov 2026 --> May 2026
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Lenvima (lenvatinib) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • raludotatug deruxtecan (DS-6000)
    9ms
    A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2/3, N=650, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • raludotatug deruxtecan (DS-6000)
    11ms
    Raludotatug Deruxtecan, a CDH6-Targeting Antibody-Drug Conjugate with a DNA Topoisomerase I Inhibitor DXd, is Efficacious in Human Ovarian and Kidney Cancer Models. (PubMed, Mol Cancer Ther)
    R-DXd demonstrated potent antitumor activity against CDH6-expressing tumors in mice and an acceptable safety profile in monkeys. These findings indicate the potential of R-DXd as a new treatment option for patients with CDH6-expressing serous-type ovarian cancer and renal cell carcinoma in a clinical setting.
    Preclinical • Journal
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    CHEK1 (Checkpoint kinase 1) • CASP3 (Caspase 3) • CDH6 (Cadherin 6)
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    CDH6 expression
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    raludotatug deruxtecan (DS-6000)
    1year
    A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2/3, N=650, Not yet recruiting, Daiichi Sankyo, Inc.
    New P2/3 trial
    |
    gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • raludotatug deruxtecan (DS-6000)
    over1year
    Targeting cadherin-6 in epithelial ovarian cancer: Clinical significance of its expression and efficacy of raludotatug deruxtecan (R-DXd) in patient-derived cell models (ESMO 2023)
    DXd demonstrated cytotoxicity in all PDC models, regardless of CDH6 expression, whereas control ADC and anti-CDH6 naked antibody showed no growth inhibitory effects. Conclusions CDH6 is an attractive target for EOC and R-DXd is a promising agent for the treatment of CDH6-expressing EOC.
    Clinical
    |
    CDH6 (Cadherin 6)
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    CDH6 expression
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    raludotatug deruxtecan (DS-6000)
    over1year
    Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer (OVC): Subgroup analysis of a first-in-human phase I study (ESMO 2023)
    Results As of 03 March 2023, 42 patients with OVC had received R-DXd at 4.8 (n = 7), 6.4 (n = 20), and 8.0 (n = 15) mg/kg: 40 (95%) had platinum-resistant disease, 29 (69%) had received prior bevacizumab, and 26 (62%) had received prior PARP inhibitors. Eleven of 21 GCIG-evaluable patients (52%) had a CA-125 response. Conclusions In heavily pretreated OVC patients without CDH6 preselection, R-DXd demonstrated acceptable safety and encouraging preliminary efficacy, which supports further clinical development in OVC.
    Clinical • P1 data • PARP Biomarker
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    MUC16 (Mucin 16, Cell Surface Associated) • CDH6 (Cadherin 6)
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    Avastin (bevacizumab) • raludotatug deruxtecan (DS-6000)
    over1year
    A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Daiichi Sankyo, Inc. | Trial completion date: Jul 2023 --> Oct 2024 | Trial primary completion date: May 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Metastases
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    raludotatug deruxtecan (DS-6000)