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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:
    6d
    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
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    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)
    2ms
    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)
    2ms
    Ovarian Tumor FAK Inhibition Releases Omega-3 Fatty Acids Stimulating GATA6 Peritoneal Macrophage CXCL13 Production Enhancing Immunotherapy. (PubMed, bioRxiv)
    We show that focal adhesion kinase (FAK) inhibition with ifebemtinib or tumor genetic FAK knockout (KO) in syngeneic ovarian tumor models stimulated resident large peritoneal macrophages to express CXCL13 chemokine and promoted B cell infiltration. reveal that tumor FAK inhibition educates macrophages to express CXCL13 associated with B cell infiltration - highlighting a new therapeutic pathway linking FAK inhibition, omega-3 fatty acid containing exosomes, and macrophage mediated anti-tumor activation. Genetic or small molecule FAK inhibition enhances ovarian tumor B cell infiltrationTumor FAK inhibition stimulates GATA6+ macrophages to make CXCL13FAKi, pegylated doxorubicin and anti-TIGIT promote tertiary lymphoid structuresOmega-3 fatty acids stimulate human HGSOC ascites macrophages to make CXCL13.
    Journal • IO biomarker
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    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • GATA6 (GATA Binding Protein 6)
    |
    doxorubicin hydrochloride • ifebemtinib (IN10018)
    3ms
    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, Not yet recruiting, InxMed (Shanghai) Co., Ltd.
    New P3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • pemetrexed • Anfangning (garsorasib) • ifebemtinib (IN10018)
    5ms
    A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=72, Recruiting, Jemincare | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • pemetrexed • ifebemtinib (IN10018) • sosimerasib (HBI-2438)
    7ms
    IN10018-010: IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov)
    P1/2, N=68, Completed, InxMed (Shanghai) Co., Ltd. | Active, not recruiting --> Completed | N=240 --> 68 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion • Enrollment change • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • ifebemtinib (IN10018)
    7ms
    IN10018 Combination Therapy in Treatment-naïve ES-SCLC (clinicaltrials.gov)
    P1/2, N=120, Recruiting, InxMed (Shanghai) Co., Ltd. | Trial primary completion date: Jan 2025 --> Dec 2025
    Trial primary completion date
    |
    carboplatin • Tevimbra (tislelizumab-jsgr) • etoposide IV • ifebemtinib (IN10018)
    7ms
    IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=168, Recruiting, InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    pegylated liposomal doxorubicin • ifebemtinib (IN10018)
    7ms
    IN10018 Combination Therapy in Previously-treated Solid Tumors (clinicaltrials.gov)
    P1/2, N=72, Not yet recruiting, InxMed (Shanghai) Co., Ltd. | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • ifebemtinib (IN10018)
    7ms
    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 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    ifebemtinib (IN10018)
    7ms
    A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=72, Not yet recruiting, Jemincare
    New P1 trial
    |
    carboplatin • pemetrexed • ifebemtinib (IN10018) • sosimerasib (HBI-2438)
    8ms
    Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1/2, N=92, Active, not recruiting, InventisBio Co., Ltd | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Anfangning (garsorasib) • ifebemtinib (IN10018)