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Basic Information Clinical Results Relationship Graph

Basic Information

GTO ID	GTC0411
Trial ID	NCT03398655
Disease	Recurrent Platinum Resistant Ovarian Cancer
Altered gene	TNFR1::Fas
Therapeutic/Target gene	Therapeutic gene
Therapy	Gene transfer
Treatment	VB111\|ofranergene obadenovec
Co-treatment	Paclitaxel
Phase	Phase3
Recruitment status	Completed
Title	A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
Year	2017
Country	Israel\|Japan\|Poland\|Spain\|United States
Company sponsor	Vascular Biogenics Ltd. operating as VBL Therapeutics
Other ID(s)	VB-111-701/GOG-3018

Vector information

Vector	adenovirus
Construct	Ad5-PPE-1-3X-TNFR1::Fas
Vector type	adenoviral serotype 5 (Ad5) vector
Transgene/Inserted gene	a Fas-TNFR1 chimeric pro-apoptotic protein
Regulatory element	a proprietary modified murine pre-endothelin 1 promoter (PPE-1-3X)

Clinical Result

Cohort1: VB111

Administration route	intravenous infusion
Dosage	1E13 vp every 2 months
Age	Adult, Older_Adult
Outcome	28.9%(ORR). A median progression-free survival (PFS) of 5.29 months and a median overall survival (OS) of 13.37 months
Adverse reactions	No serious clinical adverse events
References	PMID: 37906726 \| 32265057

Cohort2: Placebo

Administration route	intravenous infusion
Dosage	Placebo
Age	Adult, Older_Adult
Outcome	29.6%(ORR). A median progression-free survival (PFS) of 5.36 months and a median overall survival (OS) of 13.14 months
Adverse reactions	No serious clinical adverse events
References	PMID: 37906726 \| 32265057

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