Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RXRG001, Placebo.
- Who it may be relevant to
- Registry conditions: Radiation-Induced Xerostomia and Hyposalivation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Biological RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle - Biological Placebo
Placebo (saline)
Primary outcome measures
- Incidence of treatment-emergent adverse events [Time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks]
- Incidence of treatment-emergent serious adverse events [Time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks]
Eligibility criteria
Inclusion Criteria\*
- 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
Exclusion Criteria\*
- Any active infection
- Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)
- History of autoimmune diseases known to potentially affect the salivary glands
- Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
- Active smoker or use tobacco products or have a history of substance or alcohol abuse
- Other criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Iowa Hospitals and Clinics — Iowa City
- John Hopkins University, Sidney Kimmel Comprehensive Cancer Center — Baltimore
- NYU Langone Medical Center — New York
- Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman — Philadelphia
Identifiers
NCT: NCT06714253 · RX-RIX-CS101