^
    6ms
    A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=72, Recruiting, Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HBI-2376
    7ms
    GH21 Combined With D-1553 With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=126, Not yet recruiting, Suzhou Genhouse Bio Co., Ltd.
    New P1/2 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    garsorasib (D-1553) • HBI-2376
    9ms
    Dose Finding Study of GH21 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=68, Recruiting, Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2024 --> Dec 2024
    Enrollment open • Trial primary completion date • Metastases
    |
    HBI-2376
    9ms
    A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Suzhou Genhouse Bio Co., Ltd.
    New P2 trial • Metastases
    |
    HBI-2376
    10ms
    A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC (clinicaltrials.gov)
    P1/2, N=94, Recruiting, Suzhou Genhouse Bio Co., Ltd.
    New P1/2 trial • Metastases
    |
    Tagrisso (osimertinib) • HBI-2376
    2years
    A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations (ESMO Asia 2022)
    No abstract available
    Clinical • P1 data
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation
    |
    HBI-2376
    almost3years
    HBI-2376, HUYABIO clinical stage SHP2 inhibitor, possess robust in vitro potency and in vivo efficacy in several preclinical tumor models carrying KrasG12C or EGFR mutations (AACR 2022)
    Consistently, HBI-2376 found to be more efficacious in tumor growth inhibition than TNO-155 and RMC-4550 in NCI-H1975L858R_T790M_C797S osimertinib-resistant cell line and other tumor models. Furthermore, Western blotting showed inhibition of p-ERK and DUSP6 in HBI-2376 treated cells indicative of a biomarker of response to the therapy. These findings, along with a positive safety profile led to HBI-2376 IND clearance by FDA and suggested promising responses in NSCLC or CRC patients in the forthcoming clinical studies.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • DUSP6 (Dual specificity phosphatase 6)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • EGFR L858R • EGFR T790M • EGFR C797S • KRAS G12 • EGFR H1975
    |
    Tagrisso (osimertinib) • batoprotafib (TNO155) • RMC-4550 • HBI-2376
    almost3years
    A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (clinicaltrials.gov)
    P1, N=42, Recruiting, HUYABIO International, LLC. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation
    |
    HBI-2376
    3years
    A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, HUYABIO International, LLC.
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation
    |
    HBI-2376