Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
NCT ID: NCT06714253
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2025-03-05
2027-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RXRG001 Part 1
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)
RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
RXRG001 Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Placebo Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)
Placebo
Placebo (saline)
Interventions
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RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Placebo
Placebo (saline)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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RiboX Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
NYU Langone Medical Center
New York, New York, United States
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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RX-RIX-CS101
Identifier Type: -
Identifier Source: org_study_id