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    DRUG CLASS:

    cRAF inhibitor

    Related drugs:
    2d
    Effects of Cytochrome P450 enzymes and drug-drug interaction on donafenib metabolism: in vivo, in vitro and in silico. (PubMed, Bioorg Chem)
    This study systematically elucidated the metabolic characteristics of the hepatocellular carcinoma (HCC) therapeutic drug donafenib and its drug-drug interaction (DDI) with the antiviral agent arbidol. Moreover, Tmax was prolonged by 68.42%, while CLz/F was decreased by 53.85%. These results provided critical references for clinical dosage adjustment, facilitating personalized treatment and reducing the risk of adverse reactions.
    Preclinical • Journal
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    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
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    Zepsun (donafenib)
    4d
    Safety and Efficacy of Triple Therapy Containing Encorafenib, Cetuximab, and Binimetinib for BRAF V600E-Mutated Colorectal Cancer: a Systematic Review and Meta-Analysis. (PubMed, J Gastrointest Cancer)
    Triple therapy with encorafenib, cetuximab, and binimetinib offers meaningful improvements in survival and tumor response in BRAF V600E-mutated CRC, although the toxicity remains substantial. Optimizing patient selection and managing adverse events are critical for broader clinical use.
    Clinical • Retrospective data • Review • Journal
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
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    BRAF V600E • BRAF V600
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    Erbitux (cetuximab) • Mektovi (binimetinib) • Braftovi (encorafenib)
    5d
    Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Feb 2026 --> Feb 2029
    Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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    BRAF V600E • BRAF V600 • BRAF wild-type
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    Erbitux (cetuximab) • Avmapki (avutometinib) • Fakzynja (defactinib)
    10d
    Real-world characteristics and outcomes of patients with BRAFV600E-mutant metastatic colorectal cancer in Australia: the COALA project. (PubMed, ESMO Real World Data Digit Oncol)
    Uptake and impact of encorafenib plus cetuximab (EC), since being available in Australia from May 2019, were examined. The COALA study provides the first Australian real-world profile of BRAFV600E-mutated mCRC. These findings underscore the importance of early and effective therapeutic strategies, and identify a novel, disproportionately affected very-young subgroup requiring targeted research and clinical focus.
    Journal • Real-world evidence
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    BRAF (B-raf proto-oncogene)
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    BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
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    Erbitux (cetuximab) • Braftovi (encorafenib)
    10d
    Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2028 --> Dec 2026
    Trial completion date
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    BRAF V600E • BRAF V600
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    Opdivo (nivolumab) • Mektovi (binimetinib) • Braftovi (encorafenib)
    16d
    Prospective Cohort Study on the Efficacy and Safety of Sequential TIPS-TACE/HAIC Combined or Not Combined with Donafenib and Tislelizumab in the Treatment of BCLC Stage C Hepatocellular Carcinoma Patients with Concomitant Portal Hypertension (ChiCTR2600116845)
    P=N/A, N=96, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
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    Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)
    16d
    Pharmacokinetics and Individualized Dose Optimization of Donafenib in Hepatocellular Carcinoma Patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) (ChiCTR2500115846)
    P=N/A, N=20, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
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    Zepsun (donafenib)
    16d
    Donafenib monotherapy or combined with PD-1/L1 inhibitors or transcatheter arterial chemoembolization as adjuvant therapy in hepatocellular carcinoma patients with high-risk recurrence after radical resection, a multi-cohort clinical study. (ChiCTR2500112389)
    P=N/A, N=90, Recruiting, The First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Harbin Medical University
    New trial
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    AFP (Alpha-fetoprotein)
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    Zepsun (donafenib)
    16d
    Exploratory Clinical Study of TACE Combined with Iparomlimab and Tuvonralimab and Donafenib in Conversion Therapy for Unresectable Locally Advanced and Advanced Hepatocellular Carcinoma (ChiCTR2500112149)
    P=N/A, N=42, Not yet recruiting, The First Affiliated Hospital of University of science and technology of China; The First Affiliated Hospital of University of science and technology
    New trial
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    Qibeian (iparomlimab/tuvonralimab) • Zepsun (donafenib) • iparomlimab (QL1604)
    16d
    A phase Ⅱ, single-arm, exploratory study of GEMOX regimen combined with tislelizumab and donafenib in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma with high risk of recurrence (ChiCTR2500112067)
    P2, N=20, Not yet recruiting, Hunan Provincial People's Hospital; Hunan Provincial People's Hospital
    New P2 trial
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    Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)