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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03326752 | Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC | PHASE1 | COMPLETED | 26 | — | — | Sep 20, 2017 | Sep 19, 2019 | Jun 17, 2020 | 6 | United States |
Incidence of dose-limiting toxicities (DLTs)
Objective response rate (ORR) of dosing regimen established during the Dose Escalation
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort 1-5 | EXPERIMENTAL | Cohort 1-4 * DV281 - Dose Level 1-5 * DV281 in combination with nivolumab * DV281 is administered via a breath actuated nebulizer |
| Dose Expansion (RP2D) | EXPERIMENTAL | 4 Cohorts * Preliminary Recommended Phase 2 dosing of DV281 in combination with nivolumab * Cohort 1: Non-squamous and non-EGFR/ ALK mutation and progressed on anti-PD-1/L1 therapy * Cohort 2: Non-squamous and EGFR/ ALK mutation and progressed on targeted therapy * Cohort 3: Squamous and anti-PD-1/ L1 therapy experienced * Cohort 4: Squamous and anti-PD-1/L1 therapy naive * DV281 is administered via a breath actuated nebulizer. |
| Name | Type | Description |
|---|---|---|
| DV281 | DRUG | \- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts. |
| Breath Actuated Nebulizer | DEVICE | Breath-actuated, electronic system designed to aerosolize liquid medication. |
| DV281 (RP2D) | DRUG | \- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics. |
| Approved Anti-PD-1 Inhibitor | DRUG | FDA approved Anti-PD-1 Inhibitor |
Inclusion Criteria: * Have documented histologically or cytologically confirmed advanced NSCLC as the dominant histology. * If confirmed EGFR or ALK directed testing warrants actionable targeted therapy, must have confirmed disease progression on targeted therapy or cannot tolerate targeted therapy...