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RecruitingPhase 1Phase 2NCT06714253

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

Sponsor

RiboX Therapeutics Ltd.

Enrollment

42 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Radiation-Induced Xerostomia and Hyposalivation

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

Min Age: 18 Years

Inclusion Criteria4

  • At least 18 years of age
  • Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
  • Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
  • Both parotid glands on imaging examination

Exclusion Criteria6

  • Any active infection
  • Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \>=8%)
  • History of autoimmune diseases known to potentially affect the salivary glands
  • Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
  • Active smoker or use tobacco products or have a history of substance or alcohol abuse
  • Other criteria apply
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Interventions

BIOLOGICALRXRG001

Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle

BIOLOGICALPlacebo

Placebo (saline)

Locations(4)

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

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NCT06714253