Status:
COMPLETED
Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Lead Sponsor:
Eikon Therapeutics
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Tumor, Solid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04840394
Start Date
June 22 2021
End Date
September 30 2024
Last Update
November 12 2025
Active Locations (3)
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1
Florida Cancer Specialists
Sarasota, Florida, United States, 34230
2
START MidWest
Grand Rapids, Michigan, United States, 49501
3
START
San Antonio, Texas, United States, 78229