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    DRUG CLASS:

    PI3Kα H1047R mutation inhibitor

    Related drugs:
    10d
    A Study of LY4064809 in Healthy Adult Chinese Participants (clinicaltrials.gov)
    P1, N=10, Recruiting, Eli Lilly and Company
    New P1 trial
    |
    LY4064809
    24d
    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 • LY4064809
    2ms
    PIKALO-1: First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=720, Recruiting, Eli Lilly and Company | Trial completion date: Feb 2029 --> Jul 2030 | Trial primary completion date: Feb 2027 --> Jul 2030
    Trial completion date • Trial primary completion date • First-in-human
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • LY4064809
    2ms
    A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=36, Completed, Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company | Recruiting --> Completed
    Trial completion
    |
    LY4064809
    3ms
    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, Not yet recruiting, Eli Lilly and Company
    New P3 trial
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • LY4064809
    3ms
    PIKture-01: First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=200, Recruiting, OnKure, Inc. | N=150 --> 200
    Enrollment change
    |
    Herceptin (trastuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • OKI-219 • atirmociclib (PF-07220060)
    5ms
    PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov)
    P1, N=193, Active, not recruiting, Eli Lilly and Company | Trial primary completion date: May 2025 --> Dec 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    6ms
    STX-478-101: First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=720, Recruiting, Scorpion Therapeutics, Inc. | N=400 --> 720
    Enrollment change
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • LY4064809
    6ms
    A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=8, Completed, Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company | Active, not recruiting --> Completed
    Trial completion
    |
    LY4064809
    8ms
    A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    LY4064809
    8ms
    PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov)
    P1, N=193, Active, not recruiting, Eli Lilly and Company | Trial completion date: May 2025 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    8ms
    A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants (clinicaltrials.gov)
    P1, N=8, Recruiting, Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    LY4064809