Detail

Basic Information Clinical Results Relationship Graph

Basic Information

GTO ID	GTC4004
Trial ID	NCT04097002
Disease	Prostate Cancer
Altered gene	E1A\|RGD
Therapeutic/Target gene	Therapeutic gene
Therapy	DNA oncolytic virus
Treatment	ORCA-010
Phase	Phase1\|Phase2
Recruitment status	Active, Not Recruiting
Title	A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.
Year	2019
Country	Canada
Company sponsor	Orca Therapeutics B.V.
Other ID(s)	CP-ORCA-010-02-CA\|2017-002737-39\|HC6-024-C227843

Vector information

Vector	adenovirus
Construct	Ad5-delta24RGD-T1
Vector type	a first generation, replication-defective adenovirus serotype 5 (Ad5) vector
Transgene/Inserted gene	The RGD motif, consists of a 9-amino acid peptide (CDCRGDCFC) that binds to integrins (particularly αvβ3 or αvβ5).
Regulatory element	RGD-motif
Vector production method	ORCA-010 was generated by homologous recombination (HR) between a 14 kb AleI-AleI cut fragment from plasmid pAdE3/19K-445A, containing the E3/19K-T1 mutation, and pAd5-Δ24RGD, from which the 27. 5 kb PacI-SrfI fragment containing the RGD motif was excised.
Additional feature	E3/19K-T1 protein

Clinical Result

Cohort1: single dose_dose level 1

Administration route	intratumoral infusion
Dosage	single dose, 1E11 viral particles
Age	Adult, Older_Adult

Cohort2: single dose_dose level 2

Administration route	intratumoral infusion
Dosage	single dose, 5E11 viral particles
Age	Adult, Older_Adult

Cohort3: single dose_dose level 3

Administration route	intratumoral infusion
Dosage	single dose, 1.5E12 viral particles
Age	Adult, Older_Adult

Cohort4: two doses

Administration route	intratumoral infusion
Dosage	two dose administration of ORCA-010 seperated by 2 weeks,
Age	Adult, Older_Adult

Relationship Graph

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