Glioblastoma Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of EGFR (Vectibix® Sequence)-Targeted EnGeneIC Dream Vectors Containing Doxorubicin (EGFR(V)-EDV-Dox) in Subjects With Recurrent Glioblastoma Multiforme (GBM)
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).
This is an open-label, Phase 1, dose exploration and preliminary immunogenicity study of
single agent EGFR(V)-EDV-Dox in subjects with recurrent glioblastoma (GBM). Eligible subjects
enrolled in the study will receive EGFR(V)-EDV-Dox administered weekly for 7 weeks via IV 20
minute infusion, followed by radiological evaluation at week 8 (1 Cycle). Subjects may
continue to receive subsequent cycles of EGFR(V)-EDV-Dox unless the subject becomes
intolerant to investigational product (IP), withdraw consent or the individual is no longer
receiving clinical benefit (factors taken in to consideration will be disease progression
radiologically or clinically, and clinical benefits to quality of life). Tumour assessment
will be repeated after each 7 week cycle (week 8).
The study will take place in two parts, Part 1 (Dose Exploration) and Part 2 (Dose
Expansion).
Part 1 - Dose Exploration will assess the safety and tolerability of multiple doses of drug
at two dose levels (5 x 10^9 and 8 x 10^9) and will enroll prior to Part 2. Three subjects
will be recruited per dose level. Enrollment will begin with the 5 x 10^9 dose level, and the
decision to enroll to the 8 x 10^9 dose level will follow a comprehensive safety evaluation
and a standard 3 + 3 dose escalation study design.
Part 2 - Dose Expansion will be conducted pending safety results of Part 1 to provide
guidance regarding the recommended phase 2 dose (RP2D). Subjects will be treated and assessed
as outlined in Part 1 above. If 0 out of 3 subjects, or 1 out of 6 subjects, experience dose
limiting toxicities (DLTs) at the 5 x 10^9 dose level in Part 1, additional subjects to a
total of 10 will be recruited to this dose level in Part 2. Similarly, if 0 out of 3
subjects, or 1 out of 6 subjects, experience DLTs at the 8 x 10^9 dose level in Part 1,
additional subjects to a total of 10 will be recruited to this dose level in Part 2. If both
dose levels are tolerated, a total of 10 subjects per dose level will be enrolled.
A safety follow-up visit must be performed 30 (+5) days after the last dose of drug for all
subjects.All subjects who discontinue investigational product and who have not withdrawn full
consent to participate in the study will continue in the long term follow-up phase. Long term
follow-up will continue approximately every 1 month for 12 months, from the 30 (+5) day
follow-up visit, then approximately every 2-3 months for the extent of subject survival.
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|---|---|---|---|
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