Basic Information



GTO ID GTC3993
Trial ID NCT01956734
Disease Brain Glioma
Altered gene E1A|RGD
Therapeutic/Target gene Therapeutic gene
TherapyDNA oncolytic virus
Treatment Ad5-Delta 24RGD|DNX-2401|tasadenoturev
Co-treatment Temozolomide
PhasePhase1
Recruitment statusCompleted
TitlePhase I Trial of Combination of DNX-2401 (Formerly Named Delta-24-RGD) Oncolytic Adenovirus With a Short Course of Temozolomide for Treatment of Glioblastoma at First Recurrent
Year2013
CountrySpain
Company sponsorClinica Universidad de Navarra, Universidad de Navarra
Other ID(s)D24GBM EudraCT: 2011-005935-21
Vector information
Vectoradenovirus
ConstructAd5-Delta 24RGD
Vector typetumor-selective, replication-competent oncolytic adenovirus
Transgene/Inserted geneRGD-motif, which was engineered into the fiber H-loop, enabling the virus to use αvβ3 or αvβ5 integrins to enter cells.
Regulatory elementRGD-motif
Viral genome modification24-base-pair deletion in the E1A gene

Clinical Result

Cohort 1
Administration route intratumoral infusion|oral
Dosage DNX2401, 3E10 vp suspended in 1 ml|Temozolomide, 150mg/m2 in days 1-7 and 15 -21 of a 28 days cycle, (dose dense scheme 7 days on, 7 days off)
Pts 31
Age Adult, Older_Adult

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