Tumor, SolidPhase 1NCT04840394
Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
A Phase 1 study testing BDB018 and Pembrolizumab in people with Tumor, Solid, run by Eikon Therapeutics at 3 sites in United States.
Trial summary
A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- BDB018 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2021to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
START MidWest
Grand Rapids, Michigan, 49501
START
San Antonio, Texas, 78229
Florida Cancer Specialists
Sarasota, Florida, 34230
About this study
Official title: Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Read the 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.
- Conditions
- Tumor, Solid
- Being tested
- BDB018, Pembrolizumab
- Keywords
- TLR7/8, Immuno-oncology, TLR 7/8 Agonist, EIK1001
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDB018Drug
BDB018 is an immunotherapy agent.
PembrolizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BDB018 in Monotherapy | Experimental | 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. Receives: Drug: BDB018 |
| BDB018 in Combination with Pembrolizumab | Experimental | 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. Receives: Drug: BDB018; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
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
Measured: Up to 30 months
Secondary outcomes (2)
Determine Maximum Tolerated Dose
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
Measured: From first dose to 21 days after first dose for each patient (cycle 1)
Radiographic Determination of Tumor Response after BDB018 Dosing
Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST
Measured: Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 Jun 2021
- Primary completion31 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eikon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Harry Raftopoulos, MD, Study chair, Eikon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840394
- Sponsor's protocol ID
- BDB018-101
- Other IDs
- KEYNOTE-D26
- Status last verified
- Nov 2025
- First submitted
- 7 Apr 2021
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04840394
- Acronym / sponsor ID
- BDB018-101
- Conditions
- Tumor, Solid
- Keywords
- TLR7/8, Immuno-oncology, TLR 7/8 Agonist, EIK1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Eikon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDB018 in Monotherapy | Experimental | Drug: BDB018A 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 in Combination with Pembrolizumab | Experimental | Drug: BDB018, Drug: PembrolizumabIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDB018BDB018 is an immunotherapy agent. | Drug | BDB018 in Combination with Pembrolizumab, BDB018 in Monotherapy |
| PembrolizumabPembrolizumab 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. | Drug | BDB018 in Combination with Pembrolizumab |
Primary outcome
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
2 secondary outcomes
Determine Maximum Tolerated Dose
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Raftopoulos, MD study chair
Eikon Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BDB018 and Pembrolizumab in people with Tumor, Solid, run by Eikon Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.