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Brief Title: BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab
Official Title: Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Atezolizumab in Subjects With Advanced Solid Tumors
Study ID: NCT04196530
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Angeles Clinic, Los Angeles, California, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Tennessee Oncology, Nashville, Tennessee, United States
NEXT Oncology, San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Name: Harry Raftopoulos, MD
Affiliation: Eikon Therapeutics
Role: STUDY_CHAIR