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Anti-tumor antibiotic

EGFR(V)-EDV-Dox for Glioblastoma (CerebralEDV Trial)

Phase 1
Waitlist Available
Led By Stuart A Grossman, M.D.
Research Sponsored by Engeneic Pty Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dlt evaluable subjects are those who experience a dlt assessed within the first treatment cycle of part 1 i.e.including up to 7 days after the final dose, days 1-50 of treatment.
Awards & highlights

CerebralEDV Trial Summary

This study is evaluating whether a drug may help treat glioblastoma multiforme.

Eligible Conditions
  • Glioblastoma

CerebralEDV Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dlt evaluable subjects are those who experience a dlt assessed within the first treatment cycle of part 1 i.e.including up to 7 days after the final dose, days 1-50 of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and dlt evaluable subjects are those who experience a dlt assessed within the first treatment cycle of part 1 i.e.including up to 7 days after the final dose, days 1-50 of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety outcome measures
Secondary outcome measures
Efficacy outcome measure
Identification of a recommended Phase 2 dose (RP2D) of EGFR(V)-EDV-Dox in subjects with recurrent GBM
Overall survival outcome measure.

CerebralEDV Trial Design

1Treatment groups
Experimental Treatment
Group I: EGFR(V)-EDV-DoxExperimental Treatment1 Intervention
EGFR(V)-EDV-Dox administered via 20 minute intravenous infusion once a week for seven weeks (1 Cycle). Subjects will receive one of two dose levels: 5 x 10^9 or 8 x 10^9. All subjects will undergo an adapted dose escalation regime in the first cycle of treatment. For subsequent cycles all doses will be administered at full strength (5x10^9 or 8x10^9 EGFR(V)-EDV-Dox). Subjects may receive further cycles of treatment if the tumor remains stable or is responding, and/or they are deriving clinical benefit from the therapy and are tolerating treatment.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,760 Total Patients Enrolled
2 Trials studying Glioblastoma
63 Patients Enrolled for Glioblastoma
Engeneic Pty LimitedLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
Himanshu Brahmbhatt, Ph. DStudy DirectorEngeneic Pty Limited

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)
2016. "A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02766699.
~2 spots leftby Apr 2025
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