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NCT02766699: CerebralEDV

A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent GBM

Completed Phase 1 Last updated 3 June 2025
What this trial tests

Phase 1 trial testing EGFR(V)-EDV-Dox in Glioblastoma in 9 participants. Completed in 30 March 2022.

Timeline
25 October 2016
Primary endpoint
21 August 2021
30 March 2022

Quick facts

Lead sponsorEngeneic Pty Limited
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date25 October 2016
Primary completion21 August 2021
Estimated completion30 March 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Engeneic Pty Limited — full company profile →

Who can join

18 and older, any sex, with Glioblastoma or Astrocytoma, Grade IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanoparticles in the clinic: An update.
    Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
  2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
    Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
  3. EGFR heterogeneity and implications for therapeutic intervention in glioblastoma.
    Eskilsson E, Røsland GV, Solecki G, Wang Q, et al · · 2018 · cited 228× · PMID 29040782 · DOI 10.1093/neuonc/nox191
  4. Drug delivery to the central nervous system.
    Nance E, Pun SH, Saigal R, Sellers DL. · · 2022 · cited 224× · PMID 38464996 · DOI 10.1038/s41578-021-00394-w
  5. Nanoparticles in the clinic: An update post COVID-19 vaccines.
    Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
  6. A Critical Overview of Targeted Therapies for Glioblastoma.
    Jain KK. · · 2018 · cited 161× · PMID 30374421 · DOI 10.3389/fonc.2018.00419
  7. Bi-specific and tri-specific antibodies- the next big thing in solid tumor therapeutics.
    Runcie K, Budman DR, John V, Seetharamu N. · · 2018 · cited 120× · PMID 30249178 · DOI 10.1186/s10020-018-0051-4
  8. Recent advances of bispecific antibodies in solid tumors.
    Yu S, Li A, Liu Q, Yuan X, et al · · 2017 · cited 114× · PMID 28931402 · DOI 10.1186/s13045-017-0522-z

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Data sources for this page

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