NCT04043104View on ClinicalTrials.gov

A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2019

Primary Completion Date

March 28, 2023

Study Completion Date

March 28, 2023

Conditions
Radiation-Induced Parotid Gland HypofunctionXerostomia Due to RadiotherapyHead and Neck Cancer
Interventions
DRUG

AAV2hAQP1: 1 x 10^11 vg/gland (single gland)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^11 vg/gland

DRUG

AAV2hAQP1: 3 x 10^10 vg/gland (both glands)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^10 vg/gland

DRUG

AAV2hAQP1: 3 x 10^11 vg/gland (single gland)

Intra-parotid administration of AAV2hAQP1 of via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^11 vg/gland

DRUG

AAV2hAQP1: 1 x 10^11 vg/gland (both glands)

intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^11 vg/gland

DRUG

AAV2hAQP1: 1 x 10^12 vg/gland (single gland)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^12 vg/gland

DRUG

AAV2hAQP1: 3 x 10^11 vg/gland (both glands)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^11 vg/gland

DRUG

AAV2hAQP1: 3 x 10^12 vg/gland (single gland)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^12 vg/gland

DRUG

AAV2hAQP1: 1 x 10^12 vg/gland (both glands)

Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^12 vg/gland

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center, New York

28209

Atrium Health, Charlotte

40202

University of Louisville, Louisville

94305

Leland Stanford Junior University, Stanford

02184

Brigham and Women's Hospital, Boston

Unknown

Health Sciences North - Northeast Cancer Center, Greater Sudbury

All Listed Sponsors
lead

MeiraGTx UK II Ltd

INDUSTRY

NCT04043104 - A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia | Biotech Hunter | Biotech Hunter