- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840394
Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Robert Andtbacka, MD,CM,
- Phone Number: 18483000086
- Email: randtbacka@7and8biopharma.com
Study Contact Backup
- Name: Melissa Harney
- Phone Number: 18483000086
- Email: mharney@7and8biopharma.com
Study Locations
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Florida
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Sarasota, Florida, United States, 34230
- Florida Cancer Specialists
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Michigan
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Grand Rapids, Michigan, United States, 49501
- Start Midwest
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Texas
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San Antonio, Texas, United States, 78229
- START
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
BDB018 is an immunotherapy agent.
|
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. |
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.
BDB018 is an immunotherapy agent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine Maximum Tolerated Dose
Time Frame: From first dose to 21 days after first dose for each patient (cycle 1)
|
Determination of the maximum tolerated dose by assessing the frequency of BDB018 related and BDB018 and pembrolizumab-related adverse events using CTCAE version 5.0 to categorize adverse event severity
|
From first dose to 21 days after first dose for each patient (cycle 1)
|
Radiographic Determination of Tumor Response after BDB018 Dosing
Time Frame: Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)
|
Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST
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Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Harry Raftopoulos, MD, Eikon Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDB018-101
- KEYNOTE-D26 (Other Identifier: Merck Sharp & Dohme Corp)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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