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    A first-in-human Phase I dose-escalation trial of the novel therapeutic peptide, ALM201, demonstrates a favourable safety profile in unselected patients with ovarian cancer and other advanced solid tumours

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    Authors
    El Helali, A.
    Plummer, R.
    Jayson, Gordon C
    Coyle, V. M.
    Drew, Y.
    Mescallado, Nerissa
    Harris, N.
    Clamp, Andrew R
    McCann, J.
    Swaisland, H.
    Kennedy, R. D.
    Cranston, A. N.
    Wilson, R. H.
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    Affiliation
    Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, UK
    Issue Date
    2022
    
    Metadata
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    Abstract
    Background: We aimed to assess the safety, tolerability and pharmacokinetics of a novel anti-angiogenic peptide. Methods: We used an open-label, multicentre, dose-escalation Phase I trial design in patients with solid tumours. ALM201 was administered subcutaneously once daily for 5 days every week in unselected patients with solid tumours. Results: Twenty (8 male, 12 female) patients with various solid tumours were treated (18 evaluable for toxicity) over eight planned dose levels (10-300 mg). ALM201 was well-tolerated at all dose levels without CTCAE grade 4 toxicities. Adverse events were predominantly grades 1-2, most commonly, localised injection-site reactions (44.4%), vomiting (11%), fatigue (16.7%), arthralgia (5.6%) and headache (11%). Thrombosis occurred in two patients at the 100 mg and 10 mg dose levels. The MTD was not reached, and a recommended Phase II dose (RP2D) based on feasibility was declared. Plasma exposure increased with dose (less than dose-proportional at the two highest dose levels). No peptide accumulation was evident. The median treatment duration was 11.1 (range 3-18) weeks. Four of 18 evaluable patients (22%) had stable disease. Conclusions: Doses up to 300 mg of ALM201 subcutaneously are feasible and well-tolerated. Further investigation of this agent in selected tumour types/settings would benefit from patient-selection biomarkers.
    Citation
    El Helali A, Plummer R, Jayson GC, Coyle VM, Drew Y, Mescallado N, et al. A first-in-human Phase I dose-escalation trial of the novel therapeutic peptide, ALM201, demonstrates a favourable safety profile in unselected patients with ovarian cancer and other advanced solid tumours. British Journal of Cancer. Springer Science and Business Media LLC; 2022.
    Journal
    British Journal of Cancer
    URI
    http://hdl.handle.net/10541/625310
    DOI
    10.1038/s41416-022-01780-z
    PubMed ID
    35568736
    Additional Links
    https://dx.doi.org/10.1038/s41416-022-01780-z
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1038/s41416-022-01780-z
    Scopus Count
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