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

  • STATUS
    Recruiting
  • End date
    May 28, 2022
  • participants needed
    30
  • sponsor
    MeiraGTx UK II Ltd
Updated on 28 January 2021
ct scan
positron emission tomography

Summary

Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single parotid gland in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one targeted parotid gland:

To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.

Details
Condition head and neck cancer, Xerostomia Due to Radiotherapy, Radiation-Induced Parotid Gland Hypofunction, Radiation-Induced Parotid Gland Hypofunction, cancer of the head and neck, Radiation-Induced Parotid Gland Hypofunction, Radiation-Induced Parotid Gland Hypofunction, Radiation-Induced Parotid Gland Hypofunction, Radiation-Induced Parotid Gland Hypofunction, Radiation-Induced Parotid Gland Hypofunction
Treatment intra-parotid administration of AAV2hAQP1
Clinical Study IdentifierNCT04043104
SponsorMeiraGTx UK II Ltd
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiation-Induced Parotid Gland Hypofunction or head and neck cancer or Xerostomia Due to Radiotherapy?
Do you have any of these conditions: cancer of the head and neck or Xerostomia Due to Radiotherapy or head and neck cancer or Radiation-Induced Parotid Gland Hypofunction?
Do you have any of these conditions: cancer of the head and neck or head and neck cancer or Radiation-Induced Parotid Gland Hypofunction or Xerostomia Due to Radiotherapy?
Do you have any of these conditions: head and neck cancer or cancer of the head and neck or Xerostomia Due to Radiotherapy or Radiation-Induced Parotid Gland Hypofunction?
Do you have any of these conditions: cancer of the head and neck or Radiation-Induced Parotid Gland Hypofunction or head and neck cancer or Xerostomia Due to Radiotherapy?
Do you have any of these conditions: cancer of the head and neck or Xerostomia Due to Radiotherapy or head and neck cancer or Radiation-Induced Parotid Gland Hypofunction?
Male or female subjects 18 years of age
History of radiation therapy for head and neck cancer
Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland >0 and <0.3 mL/min/gland after 2% citrate stimulation
No evidence of recurrence of the primary malignancy by an otolaryngology (ears, nose, and throat [ENT]) assessment. Additionally, all subjects must be disease-free of head and neck cancer for at least 5 years following the end of treatment at screening, with the exception of subjects with a history of HPV+ OPC (base of tongue, oropharynx, pharynx, soft palate, tonsil) who must be disease free for at least 2 years following the end of treatment. Disease status will be determined by negative clinical examinations and computed tomography (CT) scans of the neck and chest. If subjects have had a magnetic resonance imaging (MRI) of the neck or a positron emission tomography (PET) scan within 6 months of screening, then a CT scan is not required, except for HPV+ OPC subjects who must have scans at 2 years post treatment
Female subjects of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) and all male subjects must use a medically accepted contraceptive regimen during their participation in the study and until all samples collected at 2 consecutive visits following AAV2hAQP1 administration are negative. Acceptable methods of contraception for male subjects include the following
Condoms with spermicide. Acceptable methods of contraception for female subjects include the following
Intrauterine device for at least 12 weeks prior to Screening
Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening
Diaphragm used in combination with spermicide
On stable medications (>2 months) for any underlying medical conditions at the time of study drug administration

Exclusion Criteria

Pregnant or lactating women or women planning to become pregnant
Any experimental therapy within 3 months before Day 1
Active infection that requires the use of intravenous antibiotics and does not resolve at least 1 week before Day 1
Uncontrolled ischemic heart disease (i.e., unstable angina, evidence of active ischemic heart disease on electrocardiogram [ECG])
History of systemic autoimmune diseases affecting the salivary glands
Use of systemic immunosuppressive medications (i.e., corticosteroids)
Note: Topical, inhaled, or intranasal corticosteroids are allowed
Malignancy, other than head and neck cancer, within the past 3 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
Active infections including, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection
White blood cell count <3000/L, absolute neutrophil count <1500/L, hemoglobin <10.0 g/dL, platelet count <100,000/L, or absolute lymphocyte count 500/L
Alanine aminotransferase and/or aspartate aminotransferase >1.5 the upper limit of normal (ULN), alkaline phosphatase >1.5 ULN, or total bilirubin >1.5 ULN with any elevation of liver enzymes
Estimated glomerular filtration rate <60 mL/min/1.73 m2 using the Modification of Diet in Renal Disease equation
Active use of tobacco products as determined by self-reporting
Allergy to iodine or shellfish, and thus unable to have sialographic evaluations
Allergy or hypersensitivity to glycopyrrolate
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