Study of RXRG001 for Radiation-Induced Dry Mouth
This study is testing a new treatment called RXRG001 for people who have dry mouth (xerostomia) and reduced saliva (hyposalivation) caused by radiation therapy. RXRG001 is a special type of genetic material (circular ribonucleic acid) that helps your body make a protein called aquaporin 1, which is involved in producing saliva. The study wants to see if RXRG001 is safe, how well people tolerate it, and if it helps improve dry mouth. You might be able to join if you are at least 18 years old, have had radiation-induced dry mouth for at least 3 months, and your cancer has not returned for at least 2 years. The study will look at any side effects you might have for up to 60 weeks.
- Study design
- This is a first-in-human study with an unclear phase, planning to enroll 42 participants. It has two parts: an initial open-label part where all participants receive RXRG001, and a later part that is randomized and double-blind, meaning some participants will receive a placebo (saline) instead of RXRG001.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 60 weeks to monitor for any side effects after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Incidence of treatment-emergent adverse eventsPart 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent adverse events
- Incidence of treatment-emergent serious adverse eventsPart 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events