NCT03326752

Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC

Phase 1b Dose Escalation and Dose Expansion Trial of DV281 in Combination With an Approved Anti-PD-1 Inhibitor in Subjects With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with nivolumabfor the treatment of NSCLC and to select a recommended phase 2 dose (RP2D).

Detailed description

Pre-clinical studies support the proposed dosing schema to be tested and a potential benefit of the combination of inhaled DV281 with nivolumab for subjects with advanced NSCLC. This study (DV9-NSC-01) is designed for establishing an immunologically optimal RP2D for inhaled DV281 in combination with an approved anti-PD-1 inhibitor. This trial, studying the potential to enhance the efficacy of an approved anti-PD-1 inhibitor in subjects with advanced NSCLC, addresses an unmet need for NSCLC patients having tumors that do not respond or do not respond adequately to anti-PD-1 inhibitor monotherapy.

Conditions

• Advanced Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DV281	\- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts.
DEVICE	Breath Actuated Nebulizer	Breath-actuated, electronic system designed to aerosolize liquid medication.
DRUG	DV281 (RP2D)	\- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics.
DRUG	Approved Anti-PD-1 Inhibitor	FDA approved Anti-PD-1 Inhibitor

Timeline

• Start date: 2017-09-20
• Primary completion: 2019-09-19
• Completion: 2019-09-19
• First posted: 2017-10-31
• Last updated: 2020-06-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study