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    DRUG:

    GFH018

    i
    Other names: GFH018, GFH-018, GFH 018
    Associations

    News

    Trials
    Company:
    GenFleet Therap
    Drug class:
    TGF-β RI kinase inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC (clinicaltrials.gov)
    P2, N=65, Completed, Genfleet Therapeutics (Shanghai) Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    cisplatin • carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • GFH018
    4ms
    A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Genfleet Therapeutics (Shanghai) Inc. | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: May 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • GFH018
    6ms
    GFH018 and toripalimab combination therapy for previously treated recurrent or metastatic nasopharyngeal carcinoma: Results from a phase 1b/2 study. (PubMed, Clin Cancer Res)
    The combination of GFH018 and toripalimab showed a manageable toxicity profile and durable antitumor activity in R/M NPC patients, especially those without prior ICI exposure.
    P1/2 data • Journal
    |
    CD8 (cluster of differentiation 8) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Loqtorzi (toripalimab-tpzi) • GFH018
    6ms
    Discovery of a Selective, Novel TGF-βR1 Inhibitor GFH018 for the Treatment of Solid Tumors. (PubMed, J Med Chem)
    In murine tumor mouse models, either the monotherapy of GFH018 or the combination with an anti-PD-L1 antibody suppressed tumor growth, and potent inhibition of cancer cell migration in vivo was observed. Mechanistic studies revealed that GFH018 not only reactivated the immune system by blocking Treg- and M2 macrophage-mediated immunosuppression but also inhibited tumor vascular angiogenesis.
    Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    GFH018
    12ms
    A Trial of GFH018 and Toripalimab in Combination with Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Genfleet Therapeutics (Shanghai) Inc. | Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Oct 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    cisplatin • carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • GFH018
    over1year
    First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-β receptor I inhibitor, in patients with advanced solid tumors. (PubMed, BMC Cancer)
    GFH018 monotherapy presented a favorable safety profile without cardiac toxicity or bleeding. Modest efficacy warrants further studies, including combination strategies.
    Clinical • P1 data • Journal • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    GFH018
    almost2years
    A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=148, Completed, Zhejiang Genfleet Therapeutics Co., Ltd. | Recruiting --> Completed | Trial completion date: Jun 2024 --> Dec 2023
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • GFH018
    over2years
    A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Zhejiang Genfleet Therapeutics Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    cisplatin • carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • GFH018
    over2years
    A Study of GFH018 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=50, Completed, Zhejiang Genfleet Therapeutics Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Feb 2023 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Aug 2022
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    GFH018
    over2years
    GFH018, a small molecular inhibitor targeting TGF-βRI kinase, in patients with advanced solid tumors: final results of the phase I study. (ASCO 2023)
    GFH018 shows a favorable safety profile and preliminary anti-tumor activity. The clinical studies of GFH018 in combination with Toripalimab and with Toripalimab + concurrent chemoradiotherapy are ongoing. Clinical trial information: NCT05051241.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    Loqtorzi (toripalimab-tpzi) • GFH018
    over3years
    Phase I study of GFH018, a small molecular TGF-βRI inhibitor, in patients (pts) with advanced solid tumors (ESMO 2022)
    Conclusions GFH018 shows a favorable safety profile and is now being tested in combination with an anti-PD-1 antibody in patients with advanced malignancies. Further studies are warranted.
    Clinical • P1 data
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    GFH018