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.
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
- Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
- No history of parotid gland cancer, recurrent cancer, or a second primary cancer
- 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 study entry (and at least 3 years after the completion of radiotherapy), then that image may be used for eligibility determination and a CT scan at screening will not be required.
- Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected to not initiate such treatment
- Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study
- Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit