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    DRUG:

    sofetabart mipitecan (LY4170156)

    i
    Other names: LY4170156, MBK-103, MBK103, MBK 103, LY 4170156, LY-4170156
    Associations

    News

    Trials
    Company:
    Eli Lilly
    Drug class:
    Topoisomerase I inhibitor, FOLR1-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    4d
    FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer (clinicaltrials.gov)
    P3, N=1630, Recruiting, Eli Lilly and Company | N=1080 --> 1630 | Trial primary completion date: Apr 2028 --> Nov 2028
    Enrollment change • Trial primary completion date • Platinum sensitive • Platinum resistant
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • sofetabart mipitecan (LY4170156)
    1m
    J5E-MC-JZXB: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants with Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (FRAmework-01) (2025-522255-25-00)
    P2/3, N=311, Not yet recruiting, Eli Lilly & Co.
    New P2/3 trial • Platinum sensitive • Platinum resistant
    |
    Avastin (bevacizumab) • carboplatin • gemcitabine • paclitaxel • doxorubicin hydrochloride • Elahere (mirvetuximab soravtansine-gynx) • topotecan • sofetabart mipitecan (LY4170156)
    2ms
    LOXO-FRA-24001: A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=495, Recruiting, Eli Lilly and Company | N=223 --> 495
    Enrollment change • First-in-human
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • itraconazole • sofetabart mipitecan (LY4170156)
    7ms
    FRAmework-01: A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (clinicaltrials.gov)
    P3, N=1080, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open • Platinum sensitive • Platinum resistant
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • sofetabart mipitecan (LY4170156)
    7ms
    LOXO-FRA-24001: A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=495, Recruiting, Eli Lilly and Company | N=360 --> 495
    Enrollment change • First-in-human
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • itraconazole • sofetabart mipitecan (LY4170156)
    8ms
    FRAmework-01: A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (clinicaltrials.gov)
    P3, N=1080, Not yet recruiting, Eli Lilly and Company
    New P3 trial • Platinum sensitive • Platinum resistant
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • sofetabart mipitecan (LY4170156)
    1year
    LOXO-FRA-24001: A Study of LY4170156 in Participants with Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=360, Recruiting, Eli Lilly and Company | N=220 --> 360
    Enrollment change
    |
    Avastin (bevacizumab) • carboplatin • sofetabart mipitecan (LY4170156)
    2years
    A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=220, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open • Tumor cell • Metastases
    |
    sofetabart mipitecan (LY4170156)
    2years
    A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=220, Not yet recruiting, Eli Lilly and Company
    New P1 trial • Tumor cell • Metastases
    |
    sofetabart mipitecan (LY4170156)
    over3years
    MBK-103, a potent novel conjugation platform-based antibody-drug conjugate, changing therapeutic options in folate receptor alpha positive cancer patients (AACR 2023)
    The compound was also very well tolerated in cynomolgus monkeys with HNSTD at 50 mg/kg and even when administered repeatedly. High conjugation yields along with 100% homogeneity are major drivers of the successful ongoing manufacturing process with planned IND submission in Q4/2023.
    Clinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression • FOLR1 positive
    |
    sofetabart mipitecan (LY4170156)