Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05926765 | A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia | PHASE2 | RECRUITING | 276 | — | — | Jun 13, 2023 | Dec 1, 2026 | Feb 2, 2026 | 33 | United States, Canada +1 |
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: AAV2-hAQP1 Group 1 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 1: AAV2-hAQP1 Group 2 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 1: Placebo group | PLACEBO_COMPARATOR | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
| Cohort 2: AAV2-hAQP1 Group 3 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 2: AAV2-hAQP1 Group 4 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 2 Placebo group | PLACEBO_COMPARATOR | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
| Name | Type | Description |
|---|---|---|
| AAV2-hAQP1 Concentration 1 | GENETIC | Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 2 | GENETIC | Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Placebo | OTHER | Administration of diluent via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 3 | GENETIC | Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 4 | GENETIC | Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
Inclusion Criteria: * Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit * No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin ...