Radiation-Induced Xerostomia and HyposalivationPhase 1/2SPRINX-1NCT06714253
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
A Phase 1/2 study testing RXRG001 in people with Radiation-Induced Xerostomia and Hyposalivation, run by RiboX Therapeutics Ltd. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Xerostomia and Hyposalivation
- What is being tested?
- RXRG001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Mar 2025to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Principal Investigator
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Principal Investigator
- Recruiting
NYU Langone Medical Center
New York, New York, 10016-6402
Principal Investigator
- Recruiting
Stanford Medicine
Palo Alto, California, 94304
Principal Investigator
- Recruiting
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania, 19104
Principal Investigator
About this study
Official title: 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 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.
- Being tested
- RXRG001, Placebo
- Keywords
- Radiation Induced Xerostomia, First-in-human, Hyposalivation, Circular ribonucleic acid, Aquaporin 1
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXRG001Biological
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
PlaceboBiological
Placebo (saline)
| Study group | Role | What they receive |
|---|---|---|
| RXRG001 Part 1 | Experimental | Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral) Receives: Biological: RXRG001 |
| RXRG001 Part 2 | Experimental | Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral) Receives: Biological: RXRG001 |
| Placebo Part 2 | Placebo comparator | Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Incidence of treatment-emergent serious adverse events
Measured: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start5 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced Xerostomia and HyposalivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 (Phase 1): single-arm, open-label Part 2 (Phase 2): randomized, double-blind, placebo-controlled, parallel-group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RiboX Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714253
- Sponsor's protocol ID
- RX-RIX-CS101
- Acronym
- SPRINX-1
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06714253
- Acronym / sponsor ID
- SPRINX-1 / RX-RIX-CS101
- Keywords
- Radiation Induced Xerostomia, First-in-human, Hyposalivation, Circular ribonucleic acid, Aquaporin 1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- RiboX Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Part 1 (Phase 1): single-arm, open-label Part 2 (Phase 2): randomized, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| RXRG001 Part 1 | Experimental | Biological: RXRG001Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral) |
| RXRG001 Part 2 | Experimental | Biological: RXRG001Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral) |
| Placebo Part 2 | Placebo comparator | Biological: PlaceboRandomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXRG001Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle | Biological | RXRG001 Part 1, RXRG001 Part 2 |
| PlaceboPlacebo (saline) | Biological | Placebo Part 2 |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent serious adverse events
Time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RXRG001 in people with Radiation-Induced Xerostomia and Hyposalivation, run by RiboX Therapeutics Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RiboX Therapeutics Ltd. (617-999-8257, RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.