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: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens
• Evidence of progressive disease (PD) within 3 months of signing the informed consent form.
• Have measurable disease
Locations
United States
Florida
Florida Cancer Specialists
Sarasota
Michigan
START MidWest
Grand Rapids
Texas
START
San Antonio
Time Frame
Start Date: 2021-06-22
Completion Date: 2025-03
Participants
Target number of participants: 1
Treatments
Experimental: 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.
Experimental: 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.
Authors
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Eikon Therapeutics