NCT06714253From ClinicalTrials.govRecruiting

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

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

Radiation-Induced Xerostomia and Hyposalivation

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: RiboX Therapeutics Ltd.
Enrolment target: 42
Started: 5 March 2025
Main results due: August 2027
Study sites: 5
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(5)

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

Showing 5 of 5 sites. 4 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06714253. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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