A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia (NCT05926765) | Clinical Trial Compass
RecruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
United States276 participantsStarted 2023-06-13
Plain-language summary
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
* No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
* An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube)
* A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing
* Average screening XQ Total Score at or above a specified threshold
* No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of signing the informed consent form (and at least 3 years after the completion of radiotherapy), then that scan may be used for eligibility determination and a CT scan at screening will not be required. If the CT of the neck captures images from the forehead down to the neck, no CT of the head is required.
* Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected not to initiate suc…
What they're measuring
1
Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score