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

No Placebo-Only Group

Summary

This trial tests a new drug that combines targeted therapy with chemotherapy for patients with recurring brain cancer. The drug aims to target cancer cells specifically, delivering chemotherapy directly to them.

Eligible Conditions

Glioblastoma
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety outcome measures

Secondary study objectives

Efficacy outcome measure

Identification of a recommended Phase 2 dose (RP2D) of EGFR(V)-EDV-Dox in subjects with recurrent GBM

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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