^
    over1year
    Tofacitinib to prevent anti-drug antibody formation against LMB-100 immunotoxin in patients with advanced mesothelin-expressing cancers. (PubMed, Front Oncol)
    Further testing of tofacitinib to prevent ADA formation is recommended in applicable non-malignant disease settings. https://www.clinicaltrials.gov/study/NCT04034238.
    Journal • Metastases
    |
    MSLN (Mesothelin) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10)
    |
    MSLN expression
    |
    tofacitinib • LMB-100
    over1year
    LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=6, Terminated, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Dec 2023 | Active, not recruiting --> Terminated; Study was terminated due to slow accrual.
    Trial completion date • Trial termination
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSLN (Mesothelin) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    KRAS mutation • EGFR mutation • MSLN expression
    |
    Keytruda (pembrolizumab) • LMB-100
    almost2years
    Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma (clinicaltrials.gov)
    P1, N=2, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Study was closed early due to slow accrual.
    Trial termination
    |
    Yervoy (ipilimumab) • LMB-100
    almost2years
    Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2027 --> Dec 2024 | Trial primary completion date: Dec 2026 --> Dec 2024
    Trial completion date • Trial primary completion date • Surgery
    |
    MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    LMB-100
    almost2years
    Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma (clinicaltrials.gov)
    P1, N=2, Completed, National Cancer Institute (NCI) | Recruiting --> Completed | N=20 --> 2
    Trial completion • Enrollment change
    |
    Yervoy (ipilimumab) • LMB-100
    over2years
    Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=19, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    tofacitinib • LMB-100
    almost3years
    Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin (clinicaltrials.gov)
    P1, N=42, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    |
    MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    LMB-100
    3years
    Anti-mesothelin immunotoxin induces mesothelioma eradication, anti-tumor immunity, and the development of tertiary lymphoid structures. (PubMed, Proc Natl Acad Sci U S A)
    LMB-100 treatment upregulates genes associated with tertiary lymphoid structures (TLS) development and induces TLS formation in tumors. In sum, immunotoxin-mediated cell death induces anti-tumor immunity and the development of TLS, which provides insights into how immunotoxins cause tumor regressions.
    Journal
    |
    CD8 (cluster of differentiation 8) • MSLN (Mesothelin) • CD4 (CD4 Molecule)
    |
    MSLN expression
    |
    LMB-100
    3years
    Systemic immune changes accompany combination treatment with immunotoxin LMB-100 and nab-paclitaxel. (PubMed, Cancer Med)
    In summary, LMB-100 treatment causes systemic immune activation. Inflammatory and immune changes that accompany drug associated CLS were characterized for the first time.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • MSLN (Mesothelin) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
    |
    CXCL8 elevation
    |
    albumin-bound paclitaxel • LMB-100
    over3years
    LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=100 --> 6
    Enrollment closed • Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSLN (Mesothelin)
    |
    KRAS mutation • EGFR mutation • ALK rearrangement • MSLN expression
    |
    Keytruda (pembrolizumab) • LMB-100
    over3years
    Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    MSLN (Mesothelin)
    |
    MSLN expression • MSLN positive
    |
    LMB-100