NCT04196530

BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab

Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Atezolizumab in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 Open-label Dose Escalation Study of BDB001 in Combination with Atezolizumab in Subjects with Advanced Solid Tumors

Detailed description

This clinical trial is a study of an experimental drug called BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system. The primary objectives of this study are to evaluate the safety and tolerability of BDB001 in combination with atezolizumab (Tecentriq) in subjects with unresectable or metastatic solid tumors who have relapsed or are refractory to standard treatment or for whom there is no approved therapy. This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 in combination with atezolizumab. The study will be conducted in two separate but independent parts: a dose escalation part with BDB001 and atezolizumab and a dose expansion part of BDB001 in combination with atezolizumab.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	BDB001 (EIK1001)	BDB001 (EIK1001) is an immunotherapy agent.
DRUG	Atezolizumab	Atezolizumab is a is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). Atezolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.

Timeline

• Start date: 2019-11-21
• Primary completion: 2024-07-31
• Completion: 2024-08-15
• First posted: 2019-12-12
• Last updated: 2025-11-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study