Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DV281 · 1 trial · 1 indication
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...
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DV281 is an investigational small molecule being developed for the treatment of advanced non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and has been studied in a completed Phase 1b trial in patients with advanced NSCLC.
DV281 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. The company is conducting clinical research on this investigational oncology therapy.
DV281 is in Phase 1 clinical development. A Phase 1b trial of DV281 in combination with an anti-PD-1 inhibitor for advanced non-small cell lung cancer has been completed. The drug remains investigational and has not been approved by regulatory authorities.
DV281 has been studied in one clinical trial, identified as NCT03326752, a Phase 1b study of DV281 combined with an anti-PD-1 inhibitor in patients with advanced non-small cell lung cancer. This trial, which enrolled 26 participants in the United States, has been completed.
DV281 is an investigational small molecule developed by Dynavax Technologies. No alternative names for DV281 have been identified in the available clinical trial information. It is being studied specifically for advanced non-small cell lung cancer.