BridgeMD
New treatment option for Radiation-Induced Xerostomia and Hyposalivation
Official title Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
ClinicalTrials.gov ID: NCT06714253
What this study is testing
What is RXRG001?
RXRG001 is an investigational medicine, being studied as a potential treatment for radiation-induced xerostomia and hyposalivation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Baltimore, Maryland, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.