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    DRUG:

    tersolisib (LY4064809)

    i
    Other names: LY4064809, STX-478, ST-814, LY-4064809, STX-H1047-PI3Kα
    Company:
    Eli Lilly
    Drug class:
    PI3Kα H1047R mutation inhibitor
    Related drugs:
    4d
    A Study of LY4064809 in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=24, Completed, Eli Lilly and Company | Active, not recruiting --> Completed
    Trial completion
    |
    tersolisib (LY4064809)
    7d
    PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=920, Recruiting, Eli Lilly and Company | N=274 --> 920
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    15d
    A Study of [14C]-LY4064809 in Healthy Participants (clinicaltrials.gov)
    P1, N=8, Recruiting, Eli Lilly and Company
    New P1 trial
    |
    tersolisib (LY4064809)
    26d
    PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=193, Recruiting, Eli Lilly and Company
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    30d
    J6M-MC-JSGD: A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (2025-522791-92-00)
    P2/3, N=36, Not yet recruiting, Eli Lilly & Co.
    New P2/3 trial
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • PIK3CA mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    2ms
    A Study of LY4064809 in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    tersolisib (LY4064809)
    3ms
    A Study of LY4064809 in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=24, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    tersolisib (LY4064809)
    3ms
    A Study of LY4064809 in Healthy Adult Chinese Participants (clinicaltrials.gov)
    P1, N=10, Completed, Eli Lilly and Company | Active, not recruiting --> Completed
    Trial completion
    |
    tersolisib (LY4064809)
    3ms
    A Study of LY4064809 in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Eli Lilly and Company
    New P1 trial
    |
    tersolisib (LY4064809)
    4ms
    A Study of LY4064809 in Healthy Adult Chinese Participants (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    tersolisib (LY4064809)
    5ms
    A Study of LY4064809 in Healthy Adult Chinese Participants (clinicaltrials.gov)
    P1, N=10, Recruiting, Eli Lilly and Company
    New P1 trial
    |
    tersolisib (LY4064809)
    5ms
    PIKALO-2: A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=920, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)