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    DRUG:

    ifebemtinib (IN10018)

    i
    Other names: IN10018, BI-853520, N10018, BI 853520, IN 10018, N 10018, BI853520, IN-10018, N-10018
    Company:
    Boehringer Ingelheim, InxMed
    Drug class:
    FAK inhibitor
    Related drugs:
    1d
    IN10018 in Combination With Dalpiciclib for Progressive Meningiomas (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Capital Medical University
    New P1 trial
    |
    AiRuiKang (dalpiciclib) • ifebemtinib (IN10018)
    2ms
    IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2025 --> Sep 2026 | Trial primary completion date: Dec 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    ifebemtinib (IN10018)
    2ms
    Inhibition of Focal Adhesion Restricts Chemoresistance in Pancreatic Cancer by Targeting SLC7A11 Mediated Ferroptosis. (PubMed, Adv Sci (Weinh))
    Gemcitabine-based chemotherapy regimens have shown limited antitumor effects for PDAC, and combination targets are urgently needed to restrict chemoresistance. Mechanistically, the focal adhesion kinase (FAK) inhibitor (IN10018) could restrict chemoresistance to Gem of PDAC by targeting SLC7A11-mediated ferroptosis through PI3K-Akt signaling pathway. For tumor microenvironment, IN10018 reduced the abundance of mesenchymal components and enhanced CD8+ T cell infiltration.
    Journal
    |
    CD8 (cluster of differentiation 8) • SLC7A11 (Solute Carrier Family 7 Member 11)
    |
    gemcitabine • ifebemtinib (IN10018)
    3ms
    IN10018 Combination Therapy in Previously-treated Solid Tumors (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, InxMed (Shanghai) Co., Ltd. | N=72 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • ifebemtinib (IN10018)
    3ms
    a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Active, not recruiting, InxMed (Shanghai) Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Anfangning (garsorasib) • ifebemtinib (IN10018)
    4ms
    IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=92, Recruiting, InxMed (Shanghai) Co., Ltd.
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    ifebemtinib (IN10018)
    4ms
    Focal adhesion kinase inhibition enhances response to checkpoint immunotherapy in hepatocellular carcinoma. (PubMed, J Transl Int Med)
    These models were treated with FAK inhibitor IN10018 as monotherapy or in combination with anti-PD-1 immunotherapy...FAK inhibitors can enhance the sensitivity of HCC to anti-PD-1 therapy by inhibiting angiogenesis and fibrosis and promoting CD8+ T cell infiltration. This effect exceeds the efficacy of the current first-line treatment, highlighting FAK inhibition as a novel and promising therapeutic strategy for HCC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8) • PTK2 (Protein Tyrosine Kinase 2)
    |
    KRAS G12D • KRAS G12
    |
    ifebemtinib (IN10018)
    5ms
    a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Anfangning (garsorasib) • ifebemtinib (IN10018)
    5ms
    A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov)
    P3, N=400, Recruiting, InxMed (Shanghai) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • pemetrexed • Anfangning (garsorasib) • ifebemtinib (IN10018)
    5ms
    IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma (clinicaltrials.gov)
    P1, N=51, Completed, InxMed (Shanghai) Co., Ltd. | Active, not recruiting --> Completed | N=120 --> 51
    Trial completion • Enrollment change
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    NRAS mutation • NRAS Q61 • NRAS G12 • NRAS G13
    |
    Tecentriq (atezolizumab) • Cotellic (cobimetinib) • ifebemtinib (IN10018)
    7ms
    Ifebemtinib and paclitaxel synergistically inhibit the proliferation and metastasis of TNBC by blocking PI3K/Akt pathway through LSD1/PIK3IP1 axis. (PubMed, Sci Rep)
    By inhibiting FAK activation and upregulating PIK3IP1, Ifebemtinib and paclitaxel blocked the PI3K/Akt pathway, effectively suppressing TNBC proliferation and metastasis. Our findings suggest that FAK may serve as a potential therapeutic target for TNBC.
    Journal
    |
    BCL2 (B-cell CLL/lymphoma 2) • CDH1 (Cadherin 1) • BAX (BCL2-associated X protein) • VIM (Vimentin) • CDH2 (Cadherin 2) • CDK1 (Cyclin-dependent kinase 1)
    |
    paclitaxel • ifebemtinib (IN10018)
    9ms
    IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial (clinicaltrials.gov)
    P2, N=25, Recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting --> Recruiting | Initiation date: Nov 2024 --> Feb 2025
    Enrollment open • Trial initiation date
    |
    albumin-bound paclitaxel • Kaitanni (cadonilimab) • ifebemtinib (IN10018)