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    DRUG:

    ORIC-114

    i
    Other names: ORIC-114, VRN07
    Company:
    ORIC Pharma, Voronoi
    Drug class:
    HER2 exon 20 mutation inhibitor
    Related drugs:
    3ms
    Effect of Food on the Pharmacokinetics of ORIC-114 (clinicaltrials.gov)
    P1, N=32, Completed, ORIC Pharmaceuticals | Recruiting --> Completed
    Trial completion
    |
    ORIC-114
    4ms
    Ph 1/2 Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration (clinicaltrials.gov)
    P1/2, N=280, Recruiting, ORIC Pharmaceuticals | Phase classification: P1 --> P1/2 | N=42 --> 280 | Trial completion date: Mar 2025 --> Mar 2026
    Phase classification • Enrollment change • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation • HER-2 exon 23 mutation
    |
    carboplatin • pemetrexed • ORIC-114
    6ms
    Effect of Food on the Pharmacokinetics of ORIC-114 (clinicaltrials.gov)
    P1, N=32, Recruiting, ORIC Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ORIC-114
    9ms
    A global phase 1b study of ORIC-114, a highly selective, brain penetrant EGFR and HER2 inhibitor, in patients with advanced solid tumors harboring EGFR Exon 20 or HER2 alterations (ESMO 2023)
    Conclusions ORIC-114 has demonstrated an acceptable safety profile and preliminary antitumor activity, including in the CNS, at doses predicted to be active. Enrollment is ongoing and updated data will be presented.
    Clinical • P1 data • EGFR exon 20 • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    ORIC-114
    9ms
    Preclinical activity of ORIC-114, a highly selective, brain penetrant, irreversible kinase inhibitor, against atypical mutations in EGFR (ESMO 2023)
    Conclusions ORIC-114 demonstrated best-in-class properties including high free unbound exposure in brain, exquisite selectivity across the kinome, and potent activity across atypical mutations in EGFR, including PACC mutations and exon 20 insertion mutations. ORIC-114 is a promising therapy for NSCLC patients with atypical mutations in EGFR, including those with active CNS metastases, and is currently being evaluated in a global clinical trial (NCT05315700).
    Preclinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 mutation
    |
    ORIC-114
    over1year
    Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration (clinicaltrials.gov)
    P1, N=42, Recruiting, ORIC Pharmaceuticals | Trial completion date: Dec 2023 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • HER2 exon 20 • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation • HER-2 exon 23 mutation
    |
    ORIC-114
    2years
    Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration (clinicaltrials.gov)
    P1, N=42, Recruiting, ORIC Pharmaceuticals
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation • HER-2 exon 23 mutation
    |
    ORIC-114
    over2years
    [VIRTUAL] ORIC-114, an orally bioavailable, irreversible kinase inhibitor, has superior brain penetrant properties and enhanced potency in preclinical studies of HER2-positive breast cancer (AACR-NCI-EORTC 2021)
    No abstract available
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    ORIC-114
    3years
    [VIRTUAL] ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor selectively targets EGFR and HER2 exon20 insertion mutants and regresses intracranial NSCLC xenograft tumors (AACR 2021)
    Once daily oral administration of ORIC-114 significantly regressed established intracranial NSCLC tumors, demonstrating greater efficacy than TAK-788, commensurate with the superior brain to plasma exposure of ORIC-114. Taken together, these data establish ORIC-114 as a selective, irreversible, and brain penetrant EGFR inhibitor, making it a promising therapeutic candidate for development in patients with tumors harboring EGFR and HER2 exon20 insertions, including those with CNS metastases. ORIC-114 is anticipated to enter a global Phase 1/2 tumor-agnostic trial in genetically defined cancers in the second half of 2021.
    EGFR exon 20
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
    |
    Exkivity (mobocertinib) • ORIC-114