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    DRUG:

    trabedersen (OT-101)

    i
    Other names: OT101, OT-101, AP 12009, AP-2/09, AP 2/09-DS
    Associations

    News

    Trials
    Company:
    Autotelic, Oncotelic, Oncotelic-Dragon Overseas JV
    Drug class:
    TGF-β2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1 (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, University of Nebraska
    New P1/2 trial • Metastases
    |
    Keytruda (pembrolizumab) • trabedersen (OT-101)
    6ms
    STOP-PC: A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=455, Recruiting, Oncotelic Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    oxaliplatin • irinotecan • trabedersen (OT-101)
    8ms
    OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition (clinicaltrials.gov)
    P2, N=63, Not yet recruiting, Oncotelic Inc. | Trial completion date: Dec 2026 --> Dec 2029 | Trial primary completion date: Dec 2025 --> Dec 2028
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • trabedersen (OT-101)
    8ms
    STOP-PC: A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=455, Not yet recruiting, Oncotelic Inc. | Phase classification: P2b --> P2/3 | Initiation date: Dec 2023 --> May 2024
    Phase classification • Trial initiation date • Combination therapy • Metastases
    |
    oxaliplatin • irinotecan • trabedersen (OT-101)
    1year
    STOP-PC: A Study of OT-101 With FOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2b, N=468, Not yet recruiting, Oncotelic Inc.
    New P2b trial • Combination therapy • Metastases
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • trabedersen (OT-101)
    1year
    OT-101 in Combination With Atezolizumab for the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, University of Washington | N=30 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • HER-2 mutation • RET fusion • ALK rearrangement • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    Tecentriq (atezolizumab) • trabedersen (OT-101)
    over1year
    OT-101 in Combination With Atezolizumab for the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, University of Washington
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • HER-2 mutation • RET fusion • ALK rearrangement • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    Tecentriq (atezolizumab) • trabedersen (OT-101)
    2years
    Clinical potential of targeting transforming growth factor beta 2 with OT-101 for post-radiation consolidation in diffuse intrinsic pontine glioma (SNO 2022)
    Multiple doses of OT-101 will be administered after completion of radiation therapy as intrathecal bolus injections. The study is designed to determine: 1) the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of OT-101, and 2) its efficacy in children with DIPG.
    Clinical
    |
    TGFB2 (Transforming Growth Factor Beta 2)
    |
    trabedersen (OT-101)
    over3years
    [VIRTUAL] Combination therapy of anti-sense oligonucleotide targeting TGF-beta2 (TASO) and IL-2 (Proleukin) has anti-cancer effect in solid cancer (AACR 2021)
    TGF-Β inhibitor (Trabedersen) and low dose IL-2 (Proleukin) combination treatment is expected to be an effective regimen in solid cancer treatment than individual treatment by alteration of tumor environment. Modulation of the dose of Proleukin expects to help reduce the toxicity of IL-2 and increase the anti-cancer effect by combination with Trabedersen.
    Combination therapy
    |
    IL2 (Interleukin 2) • TGFB1 (Transforming Growth Factor Beta 1) • FOXP3 (Forkhead Box P3) • PRKDC (Protein Kinase, DNA-Activated, Catalytic Subunit) • TGFB2 (Transforming Growth Factor Beta 2)
    |
    trabedersen (OT-101)
    over4years
    [VIRTUAL] Effect of combination therapy of anti-sense oligonucleotide targeting TGF-β2 (trabedersen) and IL-2 (proleukin) on solid cancers. (ASCO 2020)
    No abstract available
    Combination therapy
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • trabedersen (OT-101)