Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1 (SPRINX-1)

RiboX Therapeutics Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Radiation-Induced Xerostomia and Hyposalivation

Treatments: Biological: RXRG001; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06714253

RX-RIX-CS101

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

RXRG001 Part 1

Experimental group

Description:

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)

Treatment:

Biological: RXRG001

RXRG001 Part 2

Experimental group

Description:

Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)

Treatment:

Biological: RXRG001

Placebo Part 2

Placebo Comparator group

Description:

Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Treatment:

Biological: Placebo