Basic Information


GTO ID GTC0133
Trial ID NCT01502293
Disease Melanoma
Altered gene IL-12
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment Tavokinogene Telseplasmid|tavo|pIL-12
PhasePhase2
Recruitment statusCompleted
TitleA Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma
Year2011
CountryUnited States
Company sponsorOncoSec Medical Incorporated
Other ID(s)OMS-I100|11854
Vector information
Vectorplasmid

Clinical Result

Cohort1: dose level 1
Administration route intratumoral injection
Dosage 0.5 mg/mL (up to 4 tumor sites), one cycle on Days 1, 5, and 8, up to 5 cycles
Pts 30
Age Adult, Older_Adult
Outcome 9/28(ORR)
Adverse reactions 2/30(Musculoskeletal and connective tissue disorders; Nervous system disorders)
References PMID: 31852717
Cohort2: dose level 2
Administration route intratumoral injection
Dosage 0.5 mg/mL (up to 4 tumor sites), one cycle on Days 1, 8, and 15, up to 9 cycles
Pts 17
Age Adult, Older_Adult
Outcome 4/16(ORR)
Adverse reactions 3/17(Infections and infestations; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References PMID: 31852717
Cohort3: dose level 3
Administration route intratumoral injection
Dosage 0.5 mg/mL (up to 4 tumor sites), one cycle on Days 1, 5, and 8, up to 2 cycles
Pts 4
Age Adult, Older_Adult
Outcome 1/4(ORR)
Adverse reactions No serious clinical adverse events
References PMID: 31852717

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