Basic Information



GTO ID GTC4014
Trial ID NCT03916510
Disease Rectum Cancer
Altered gene E1A|E1B
Therapeutic/Target gene Therapeutic gene
TherapyDNA oncolytic virus
Treatment ColoAd1|Enadenotucirev
Co-treatment Capecitabine|Radiotherapy
PhasePhase1
Recruitment statusCompleted
TitleA Phase 1 Trial of the Safety, Tolerability and Biological Effects of Intravenous Enadenotucirev, a Novel Oncolytic Virus, in Combination With Chemoradiotherapy in Locally Advanced Rectal Cancer
Year2019
CountryUnited Kingdom
Company sponsorUniversity of Oxford
Other ID(s)OCTO_081
Vector information
Vectoradenovirus
ConstructB Ad11p/Ad3 chimeric adenovirus
Vector typenovel group B Ad11p/Ad3 chimeric adenovirus
Transgene/Inserted geneAd11p; Ad3

Clinical Result

Cohort1: dose level 1
Administration route intravenous infusion
Dosage Enadenotucirev, Loading dose pre chemoradiation (CRT) - 1x10^12 viral particles (vp)|Radiotherapy, 50 Gy/25#
Age Adult, Older_Adult
References PMID: 32532291
Cohort2: dose level 2
Administration route intravenous infusion
Dosage Enadenotucirev, Loading dose pre CRT - 1E12 vp, Maintenance dose post CRT - 1E12vp|Radiotherapy, 50 Gy/25#
Age Adult, Older_Adult
References PMID: 32532291
Cohort3: dose level 3
Administration route intravenous infusion
Dosage Enadenotucirev, Loading dose pre CRT - 3E12vp, Maintenance dose post CRT - 3E12vp|Radiotherapy, 50 Gy/25#
Age Adult, Older_Adult
References PMID: 32532291
Cohort4: dose level 4
Administration route intravenous infusion
Dosage Enadenotucirev, Loading dose pre CRT - 3E12vp, Concurrent doses on Week 1, Day 1 and Day 5 of CRT - 3E12vp, Maintenance post CRT - 3x10^12vp|Radiotherapy, 50 Gy/25#
Age Adult, Older_Adult
References PMID: 32532291

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