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    DRUG:

    RLY-5836

    i
    Other names: RLY-5836, RLY5836, RLY 5836
    Associations

    News

    Trials
    Company:
    Relay Therap
    Drug class:
    pan-mutant PIK3CA-selective inhibitor
    Related drugs:
    Associations

    News

    Trials
    10ms
    First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=265, Active, not recruiting, Relay Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Jul 2024 | Trial primary completion date: Dec 2025 --> Jun 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 negative • PIK3CA mutation
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • RLY-5836
    1year
    A first-in-human study of the highly selective PI3Kα inhibitor RLY-5836 in patients with advanced breast cancer and other solid tumors (SABCS 2023)
    Alpelisib, a non-selective orthosteric PI3Kα inhibitor, is approved in combination with fulvestrant for patients with PIK3CA-mutant, ER+, HER2– advanced breast cancer...It is molecularly distinct with differentiated pharmaceutical properties compared to RLY-2608...This study (NCT05759949) is enrolling in the United States. For further information, please contact clinicaltrials@relaytx.com.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • RLY-2608 • RLY-5836
    over1year
    First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=220, Recruiting, Relay Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • RLY-5836
    almost2years
    First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=220, Not yet recruiting, Relay Therapeutics, Inc.
    New P1 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • RLY-5836
    over2years
    First-in-human global multi-center study of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, as a single agent in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced breast cancer. (ASCO 2022)
    Toxicity related to non-selective inhibition of WT PI3Kα (hyperglycemia) and other PI3K isoforms limits the tolerability, dosing and efficacy of the orthosteric inhibitor, alpelisib, the only approved solid tumor PI3K inhibitor...The primary endpoints are MTD/RP2D and AE profile for single agent and combination; key secondary endpoints are PI3KCA genotype in blood and tumor, PK, biomarkers, and overall response rate. US enrollment began December 2021 and ex-USA startup is underway.
    Clinical • P1 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • RLY-2608 • RLY-5836