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    DRUG:

    Vesique (nitroxoline)

    i
    Other names: APL-1202, APL 1202
    Associations

    News

    Trials
    Company:
    Asieris
    Drug class:
    MetAP2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1year
    YHGT-APL1501-NHS-103: A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers (clinicaltrials.gov)
    P1, N=12, Terminated, Syneos Health | N=32 --> 12 | Trial completion date: Oct 2024 --> Jul 2024 | Not yet recruiting --> Terminated; Study terminated by sponsor due a business decision and development strategy.
    Enrollment change • Trial completion date • Trial termination
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    Vesique (nitroxoline)
    over1year
    A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Syneos Health
    New P1 trial
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    Vesique (nitroxoline)
    2years
    Oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC): Interim analysis of ANTICIPATE phase II trial. (ASCO-GU 2024)
    Clinical Trial Registration Number: NCT04813107 Background: APL-1202 (nitroxoline) is a reversible and orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor activities. The pCR rates in both group 1 (APL-1202 plus tislelizumab) and group 2 (tislelizumab) exceeded thresholds to trigger expansion to stage 2 of the 2-stage design. The activity and safety of neoadjuvant APL-1202 plus tislelizumab support further evaluation of this novel regimen (NCT04813107). Clinical trial information: NCT04813107.
    Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 expression
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    VENTANA PD-L1 (SP263) Assay
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    Tevimbra (tislelizumab-jsgr) • Vesique (nitroxoline)
    almost3years
    ANTICIPATE phase I: Oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC). (ASCO 2023)
    Background: APL-1202 (nitroxoline) is a reversible and orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor activities. APL-1202 plus tislelizumab was well tolerated. The RP2D of APL-1202 was identified as 1125 mg daily dose. Early efficacy signals were observed including pathologic downstaging to < pT2 (5/8, 62.5%) and pT0 (1/8, 12.5%).
    Combination therapy • Clinical • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    VENTANA PD-L1 (SP263) Assay
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    Tevimbra (tislelizumab-jsgr) • Vesique (nitroxoline)
    4years
    A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1/2, N=79, Recruiting, Jiangsu Yahong Meditech Co., Ltd aka Asieris | Not yet recruiting --> Recruiting | Initiation date: Sep 2021 --> Dec 2021
    Enrollment open • Trial initiation date • Combination therapy • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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    PD-L1 expression
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    Tevimbra (tislelizumab-jsgr) • Vesique (nitroxoline)
    almost5years
    A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1/2, N=79, Not yet recruiting, Jiangsu Yahong Meditech Co.,Ltd.
    Clinical • New P1/2 trial • Combination therapy • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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    PD-L1 expression
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    Tevimbra (tislelizumab-jsgr) • Vesique (nitroxoline)
    almost6years
    [VIRTUAL] Phase Ib study: APL-1202 (APL) in combination with Bacillus Calmette-Guerin (BCG) in recurrent non-muscle invasive bladder cancer (NMIBC). (ASCO 2020)
    APL was well tolerated when given for 12 wks to NMIBC pts who also received induction or maintenance BCG. Further study of APL in combination with BCG is warranted. Research Funding: Asuerus
    P1 data • Combination therapy
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    PD-1 (Programmed cell death 1)
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    Vesique (nitroxoline)