Treatment for dry mouth caused by radiation therapy
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
This study is testing a new treatment for dry mouth caused by radiation therapy to see if it can help adults who haven't found relief from other options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RiboX Therapeutics Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Trial ID | NCT06714253 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety, tolerability, and efficacy of RXRG001, a circular RNA treatment, administered in the ducts of the parotid glands for adult patients suffering from radiation-induced xerostomia and hyposalivation. The study consists of two parts: the first part is an open-label, single-arm design with ascending doses, while the second part is a randomized, double-blind, placebo-controlled design with bilateral administrations. The aim is to determine the effectiveness of RXRG001 in alleviating symptoms of dry mouth in patients who have not found relief from previous treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a history of head and neck cancer and are experiencing persistent xerostomia or hyposalivation after radiation treatment.
Not a fit: Patients with active infections, uncontrolled diabetes, or other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dry mouth due to radiation therapy.
How similar studies have performed: While this approach is novel, similar studies targeting xerostomia have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa and 3 other locations
- 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)
Study contacts
- Study coordinator: RiboX Therapeutics Ltd.
- Email: RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com
- Phone: 617-999-8257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.