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    DRUG:

    SOMther (lutetium-177 DOTA satoreotide)

    i
    Other names: OPS201, OPS-201, 177Lu-OPS201, 177LU-OPS 201, 177Lu-DOTA- JR11, 177Lu-satoreotide, [177Lu]Lu-SSO110
    Associations

    News

    Trials
    Company:
    Ariceum Therap
    Drug class:
    Ionizing radiation emitter, SSTR2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    8ms
    Dosimetry and pharmacokinetics of [177Lu]Lu-satoreotide tetraxetan in patients with progressive neuroendocrine tumours. (PubMed, Eur J Nucl Med Mol Imaging)
    [177Lu]Lu-satoreotide tetraxetan showed a favourable dosimetry profile, with high and prolonged tumour uptake, supporting its acceptable safety profile and promising efficacy.
    PK/PD data • Journal
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    SSTR (Somatostatin Receptor)
    |
    SOMther (lutetium-177 DOTA satoreotide)
    12ms
    A phase I/II study of the safety and efficacy of [Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. (PubMed, Eur J Nucl Med Mol Imaging)
    [Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.
    P1/2 data • Clinical Trial,Phase II • Journal • Metastases
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    SOMther (lutetium-177 DOTA satoreotide)
    1year
    Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC) (ACTRN12623000185662)
    P1, N=70, Recruiting, Ariceum Therapeutics Australia Pty Ltd | Initiation date: Jun 2000 --> Jun 2023
    Trial initiation date
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    Tecentriq (atezolizumab) • SOMther (lutetium-177 DOTA satoreotide)
    over2years
    Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs (clinicaltrials.gov)
    P1/2, N=40, Terminated, Ipsen | Trial completion date: Jan 2023 --> Feb 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> Feb 2022; Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.
    Trial completion date • Trial termination • Trial primary completion date
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    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    dexamethasone • SOMther (lutetium-177 DOTA satoreotide) • ondansetron
    almost3years
    Distinct In Vitro Binding Profile of the Somatostatin Receptor Subtype 2 Antagonist [Lu]Lu-OPS201 Compared to the Agonist [Lu]Lu-DOTA-TATE. (PubMed, Pharmaceuticals (Basel))
    Whereas most of [Lu]Lu-OPS201 remained at the cell surface, [Lu]Lu-DOTA-TATE was almost completely internalised inside the cell. The present data identified distinct differences between [Lu]Lu-OPS201 and [Lu]Lu-DOTA-TATE regarding the recognition of receptor binding sites (higher for [Lu]Lu-OPS201) and their kinetics (faster association and slower dissociation of [Lu]Lu-OPS201) that explain, to a great extent, the improved therapeutic efficacy of [Lu]Lu-OPS201 compared to [Lu]Lu-DOTA-TATE.
    Preclinical • Journal
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    SSTR (Somatostatin Receptor)
    |
    Lutathera (lutetium Lu 177 dotatate) • SOMther (lutetium-177 DOTA satoreotide)
    3years
    [VIRTUAL] Safety and Effectiveness of 177LuSatoreotide Tetraxetan in Patients with Progressive Neuroendocrine Tumors (NETs): Interim Analysis of a Phase I/II Study (NANETS 2021)
    These preliminary data, reporting an acceptable safety profile and a high DCR, are promising and support a potential role for 177Lu-satoreotide tetraxetan in treating advanced NETs.
    Clinical • P1/2 data
    |
    SSTR (Somatostatin Receptor)
    |
    SOMther (lutetium-177 DOTA satoreotide)
    3years
    Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Ipsen | Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    dexamethasone • SOMther (lutetium-177 DOTA satoreotide) • ondansetron
    over3years
    PROMENADE: Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide (clinicaltrials.gov)
    P1, N=18, Recruiting, University Hospital, Basel, Switzerland
    New P1 trial
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR Expression
    |
    SOMther (lutetium-177 DOTA satoreotide) • Solucin (177Lu-edotreotide)
    over4years
    Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2) (clinicaltrials.gov)
    P1/2, N=9, Terminated, Ipsen | Withdrawn --> Terminated; High number of screen failures
    Clinical • Trial termination
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    SOMther (lutetium-177 DOTA satoreotide)
    almost5years
    Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2) (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Ipsen | N=30 --> 0 | Trial completion date: Dec 2024 --> Oct 2019 | Recruiting --> Withdrawn | Trial primary completion date: Feb 2021 --> Oct 2019
    Clinical • Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    SOMther (lutetium-177 DOTA satoreotide)