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NCT06714253PHASE1, PHASE2Recruiting

Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1

RiboX Therapeutics Ltd.

Start Date

3/5/2025

Completion Date

8/1/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria\* 1. At least 18 years of age 2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years 3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months 4. 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

Interventions

BIOLOGICAL

RXRG001

BIOLOGICAL

Placebo

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Conditions

Radiation-Induced Xerostomia and Hyposalivation

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

John Hopkins University, Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland 21287

United States

NYU Langone Medical Center

New York, New York 10016-6402

United States

Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman

Philadelphia, Pennsylvania 19104

United States