Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eikon Therapeutics
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
Study Overview
Brief Summary
A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Detailed Description
This clinical trial is a study of an experimental drug called BDB018. BDB018 is a next-generation Toll-like receptor (TLR) 7/8 agonist that activates the immune system.
The primary objectives of this study are to evaluate the safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab (Keytruda) in subjects with unresectable or metastatic solid tumors that have relapsed or are refractory to standard treatment or for which there is no approved therapy.
This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB018 in monotherapy and in combination with pembrolizumab.
The study will be conducted in two separate but independent parts: a dose escalation part with BDB018 in monotherapy and in combination with pembrolizumab and a dose expansion part of BDB018 in combination with pembrolizumab.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Has disease that is suitable for local therapy administered with curative intent.
- •Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
BDB018 in Monotherapy
A single subject will be enrolled at each dose level in the single agent arm.
Then dosage escalation will follow a traditional 3+3 dose escalation design.
Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of single agent BDB018 is reached.
Intervention: BDB018 (Drug)
BDB018 in Combination with Pembrolizumab
In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels.
When the MTD or RP2D of single agent BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study.
Intervention: BDB018 (Drug)
BDB018 in Combination with Pembrolizumab
In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels.
When the MTD or RP2D of single agent BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study.
Intervention: Pembrolizumab (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
Time Frame: Up to 30 months
Safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab as measured by the incidence of adverse events and any dose limiting toxicity
Secondary Outcomes
- Determine Maximum Tolerated Dose(From first dose to 21 days after first dose for each patient (cycle 1))
- Radiographic Determination of Tumor Response after BDB018 Dosing(Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days))