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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllRiboX Therapeutics Ltd.
NCT06714253 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • RXRG001
  • Placebo
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Where

5 sites
Stanford Medicine
Palo Alto, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, United States
NYU Langone Medical Center
New York, United States
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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