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    DRUG:

    davamotecan pegadexamer (EP0057)

    i
    Other names: EP0057, CRLX101, CRLX 101, IT-101, Cyclosert-enhanced camptothecin, NLG207, IT 101, nanoparticle-drug conjugate with camptothecin
    Associations

    News

    Trials
    Company:
    Ellipses Pharma, Lumos Pharma
    Drug class:
    Topoisomerase I inhibitor, HIF-1α inhibitor
    Related drugs:
    Associations

    News

    Trials
    9ms
    EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=34, Completed, Ellipses Pharma | Active, not recruiting --> Completed | N=60 --> 34
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    11ms
    EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Ellipses Pharma | N=115 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • ATM (ATM serine/threonine kinase)
    |
    ATM expression
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    over1year
    EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=115, Not yet recruiting, Ellipses Pharma | Initiation date: Jul 2022 --> Apr 2023
    Trial initiation date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • ATM (ATM serine/threonine kinase)
    |
    ATM expression
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    over1year
    EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Ellipses Pharma | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Mar 2023
    Enrollment closed • Trial completion date • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    almost2years
    EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=115, Not yet recruiting, Ellipses Pharma
    New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • ATM (ATM serine/threonine kinase)
    |
    ATM expression
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    almost3years
    EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Ellipses Pharma | Trial primary completion date: Jul 2022 --> Nov 2022
    Clinical • Trial primary completion date • Combination therapy
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    3years
    Anti-tumor activity of NLG207 (formerly CRLX101) in combination with enzalutamide in preclinical prostate cancer models. (PubMed, Mol Cancer Ther)
    Combination treatment with NLG207, a nanoparticle-drug conjugate of camptothecin and inhibitor of HIF-1α, and enzalutamide was evaluated in preclinical prostate cancer models of enzalutamide resistance. Combination treatment with NLG207 and enzalutamide was shown to be effective in preclinical prostate cancer models of enzalutamide resistance. Clinical investigation of this treatment combination is ongoing (NCT03531827).
    Preclinical • Journal • Combination therapy
    |
    HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    HIF1A expression
    |
    Xtandi (enzalutamide capsule) • irinotecan • davamotecan pegadexamer (EP0057)
    over3years
    EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Ellipses Pharma | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy • BRCA Biomarker • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    over3years
    EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Ellipses Pharma
    Clinical • New P2 trial • Combination therapy • BRCA Biomarker • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Lynparza (olaparib) • davamotecan pegadexamer (EP0057)
    4years
    Host immune response to anti-cancer camptothecin conjugated cyclodextrin-based polymers. (PubMed, J Biomed Sci)
    Drugs administration in whole-body circulation may lead to poorly bioavailable in central nervous system and often has toxic effects on peripheral tissues. Conjugated with cyclodextrin-based polymers not only reduce adverse effects but also modulate the immune responses to elevate drug efficacy. These immune responses may potentially facilitate actions of immune blockage, such as PD1/PDL1 in cancer treatment.
    Review • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    irinotecan • davamotecan pegadexamer (EP0057)