Clinical trial NCT06714253: Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Radiation-Induced Xerostomia and Hyposalivation
Keywords: Radiation Induced Xerostomia
First-in-human
Hyposalivation
Circular ribonucleic acid
Aquaporin 1
Lead sponsor: RiboX Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 (Phase 1): single-arm, open-label Part 2 (Phase 2): randomized, double-blind, placebo-controlled, parallel-group
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: Inclusion Criteria\*

1. At least 18 years of age
2. History of radiation treatment or chemoradiotherapy for head and neck cancer for stage 2 or higher
3. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
4. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
5. 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Part 1: up to 36 weeks, Part 2: up to 36 weeks
measure: Incidence of treatment-emergent serious adverse events
timeFrame: Part 1: up to 36 weeks, Part 2: up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Philadelphia
country: United States
facility: Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
state: Pennsylvania
Study officials:
References: