Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
NCT ID: NCT04840394
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2021-06-22
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
BDB018
BDB018 is an immunotherapy agent.
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.
BDB018
BDB018 is an immunotherapy agent.
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.
Interventions
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BDB018
BDB018 is an immunotherapy agent.
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.
Eligibility Criteria
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Inclusion Criteria
2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form.
3. Have measurable disease
Exclusion Criteria
2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eikon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Harry Raftopoulos, MD
Role: STUDY_CHAIR
Eikon Therapeutics
Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
START MidWest
Grand Rapids, Michigan, United States
START
San Antonio, Texas, United States
Countries
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Other Identifiers
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KEYNOTE-D26
Identifier Type: OTHER
Identifier Source: secondary_id
BDB018-101
Identifier Type: -
Identifier Source: org_study_id