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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04043104 | A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia | PHASE1 | COMPLETED | 24 | — | — | Jun 30, 2019 | Mar 28, 2023 | Apr 24, 2023 | 6 | United States, Canada |
Safety will be assessed by number of adverse events occurring with treatment
| Arm | Type | Description |
|---|---|---|
| 1 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^10 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (both glands) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AAV2hAQP1: 1 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^10 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^10 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 of via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^11 vg/gland (both glands) | DRUG | intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^12 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^12 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^12 vg/gland |
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. History of radiation therapy for head and neck cancer. 3. Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland \>0 and ...