Overview

This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production).

In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts.

Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.

Eligibility

Inclusion Criteria*

1. At least 18 years of age
2. History of radiation treatment or chemoradiotherapy for head and neck cancer for stage 2 or higher
3. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
4. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
5. Both parotid glands on imaging examination

Exclusion Criteria*

1. Any active infection
2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)
3. History of autoimmune diseases known to potentially affect the salivary glands
4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
5. Active smoker or use tobacco products or have a history of substance or alcohol abuse
   • Other criteria apply