NCT03486301

BDB001-101: Clinical Study of BDB001 as a Mono-therapy or in Combination With Pembrolizumab

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in combination with Pembrolizumab 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 as a single agent and in combination with pembrolizumab and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) when given in combination with pembrolizumab in subjects with advanced solid tumors. This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 as a single agent and in combination with pembrolizumab in subjects with histologically-confirmed, incurable, unresectable or metastatic solid tumors that have relapsed or are refractory to standard therapies or for whom there is no approved therapy. The study will be conducted in two separate but independent dose escalation arms: a single agent arm (BDB001 alone) and a combination arm (BDB001 in combination with pembrolizumab). Participants will be allowed to continue treatment beyond study termination until occurrence of significant treatment-related toxicity, progressive disease or discontinuation criteria are met.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	BDB001 (EIK1001)	BDB001 (EIK1001) is an immunotherapy agent.
DRUG	Pembrolizumab	Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.

Timeline

• Start date: 2018-02-15
• Primary completion: 2024-03-31
• Completion: 2024-04-30
• First posted: 2018-04-03
• Last updated: 2025-11-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study