A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• At least 18 years of age
• Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
• Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
• Both parotid glands on imaging examination
Locations
United States
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Maryland
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
New York
NYU Langone Medical Center
RECRUITING
New York
Pennsylvania
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral)
Experimental: RXRG001 Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
Placebo_comparator: Placebo Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)