Actively Recruiting
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Led by RiboX Therapeutics Ltd. · Updated on 2026-04-29
42
Participants Needed
4
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- No cancer recurrence and no other cancer for at least 2 years
- Experiencing xerostomia and/or hyposalivation with symptoms unresolved after at least 3 months of treatment
- Both parotid glands visible on imaging examination
You will not qualify if you...
- Any active infection
- Heart failure, reduced kidney function, or uncontrolled diabetes (Hemoglobin A1c >=8%)
- History of autoimmune diseases affecting the salivary glands
- Any malignancy other than head and neck cancer within the past 3 years, except certain skin and cervical cancers
- Active smoker, use of tobacco products, or history of substance or alcohol abuse
- Other unspecified criteria apply
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
NYU Langone Medical Center
New York, New York, United States, 10016-6402
Actively Recruiting
4
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
R
RiboX Therapeutics Ltd.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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