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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

RXRG001 (biological)
Placebo (biological)

Sponsor: RiboX Therapeutics Ltd. · Participants: 42 · Started: Mar 5, 2025

Contact the study team

RiboX Therapeutics Ltd. · Phone: 617-999-8257

Official record on ClinicalTrials.gov — NCT06714253

Locations in the U.S.

California	Stanford Medicine, Palo Alto (Not yet recruiting)
Iowa	University of Iowa Hospitals and Clinics, Iowa City
Maryland	John Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore
New York	NYU Langone Medical Center, New York
Pennsylvania	Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman, Philadelphia

Conditions

Dry Mouth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.