Tumor, SolidPhase 1EIK1001NCT03486301
BDB001-101: Clinical Study of BDB001 as a Mono-therapy or in Combination With Pembrolizumab
A Phase 1 study testing BDB001 (EIK1001) and Pembrolizumab in people with Tumor, Solid, run by Eikon Therapeutics at 5 sites in United States.
Trial summary
Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent 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?
- BDB001 (EIK1001) and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Feb 2018to 30 Apr 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Be 18 years of age on day of signing informed consent
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors who 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
- A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
Show all 12Show fewer
- A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment • A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly)
- Evidence of progressive disease (PD) within 3 months of signing the informed consent form
- Have measurable disease per irRECIST as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
- Minimum life expectancy of 3 months
- Have adequate organ function as defined by the protocol. Specimens must be collected within 10 days prior to the start of study treatment.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- A woman of child bearing potential who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Prior exposure to TLR 7 agonists (e.g., GS-9620, imiquimod, TMX 101, resiquimod, MEDI9197, 825A) and TLR 9 agonists (e.g., SD-101, IMO2125, MGN1703, GNKG168, DUK-CPG-001 and CMP-001) for treatment of the solid tumor the patient is currently being evaluated for treatment with BDB001.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE
- Received previous therapy for malignancy within 21 days prior to administration of study drug, including any investigational agents (other than BDB001), chemotherapy, immunotherapy, biological or hormonal therapy (6 weeks for nitrosoureas or mitomycin C)
- Major surgery within 4 weeks of first dose of study drug
Show all 27Show fewer
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
- Currently receiving medications known to be strong inhibitors of CYP1A and CYP3A and strong/moderate inducers of CYP1A and CYP3A
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 21 days prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
- History within last 6 months of New York Heart Association Class III or IV heart failure, acute myocardial infarction, angina pectoris, uncontrolled arrhythmia, acute coronary syndromes, stent placement, uncontrolled hypertension
- QTc interval value > 470 msec (using Fridericia's Correction)
- Left ventricular ejection fraction (LVEF) < 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment (Kim 2017).
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
- Known active hepatitis A, B or C. Subjects who are HBsAg+ and have DNA load < 2000 IU/mL (104 copies/mL) are eligible to participate in the study provided they meet the ALT and bilirubin inclusion criteria.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- Has had an allogenic tissue/solid organ transplant
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- History of interstitial lung disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Atlantic Health
Morristown, New Jersey, 07960
Tennessee Oncology
Nashville, Tennessee, 37203
NEXT Oncology
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics (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
Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent 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 BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system.
The primary objectives of this study are to evaluate the safety and tolerability of BDB001 as a single agent and in combination with pembrolizumab and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) when given in combination with pembrolizumab in subjects with advanced solid tumors.
This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 as a single agent and in combination with pembrolizumab in subjects with histologically-confirmed, incurable, unresectable or metastatic solid tumors that have relapsed or are refractory to standard therapies or for whom there is no approved therapy.
The study will be conducted in two separate but independent dose escalation arms: a single agent arm (BDB001 alone) and a combination arm (BDB001 in combination with pembrolizumab).
Participants will be allowed to continue treatment beyond study termination until occurrence of significant treatment-related toxicity, progressive disease or discontinuation criteria are met.
- Conditions
- Tumor, Solid
- Being tested
- BDB001 (EIK1001), Pembrolizumab
- Keywords
- TLR7/8, Immuno-oncology, EIK1001
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDB001 (EIK1001)Drug
BDB001 (EIK1001) 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 |
|---|---|---|
| Single Agent BDB001 (EIK1001) | Experimental | A single subject will be enrolled at each dose level in the single agent arm until any ≥ Grade 2 treatment-emergent adverse event (TEAE) is observed in the first cycle.
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 BDB001 is reached. Receives: Drug: BDB001 (EIK1001) |
| BDB001 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 BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, twenty additional subjects will be enrolled in the expansion phase of the study. Receives: Drug: BDB001 (EIK1001); 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 BDB001 as a single agent 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 BDB001-related and BDB001 and pembrolizumab-related adverse events using CTCAE version 4.03 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 BDB001 Dosing
Radiographic determination of tumor response in subjects dosed with BDB001 and BDB001 and pembrolizumab 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 posted3 Apr 2018
- Study start15 Feb 2018
- Primary completion31 Mar 2024
- Study completion30 Apr 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
- Model description
- BDB001 followed by combination treatment with KEYTRUDA®
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT03486301
- Sponsor's protocol ID
- BDB001-101
- Other IDs
- KEYNOTE-914
- Acronym
- EIK1001
- Status last verified
- Nov 2025
- First submitted
- 28 Feb 2018
- 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
- NCT03486301
- Acronym / sponsor ID
- EIK1001 / BDB001-101
- Conditions
- Tumor, Solid
- Keywords
- TLR7/8, Immuno-oncology, EIK1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Eikon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 Apr 2018 (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.
Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Detailed description
This clinical trial is a study of an experimental drug called BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system.
The primary objectives of this study are to evaluate the safety and tolerability of BDB001 as a single agent and in combination with pembrolizumab and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) when given in combination with pembrolizumab in subjects with advanced solid tumors.
This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 as a single agent and in combination with pembrolizumab in subjects with histologically-confirmed, incurable, unresectable or metastatic solid tumors that have relapsed or are refractory to standard therapies or for whom there is no approved therapy.
The study will be conducted in two separate but independent dose escalation arms: a single agent arm (BDB001 alone) and a combination arm (BDB001 in combination with pembrolizumab).
Participants will be allowed to continue treatment beyond study termination until occurrence of significant treatment-related toxicity, progressive disease or discontinuation criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- BDB001 followed by combination treatment with KEYTRUDA®
| Arm | Type | Receives |
|---|---|---|
| Single Agent BDB001 (EIK1001) | Experimental | Drug: BDB001 (EIK1001)A single subject will be enrolled at each dose level in the single agent arm until any ≥ Grade 2 treatment-emergent adverse event (TEAE) is observed in the first cycle. 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 BDB001 is reached. |
| BDB001 in Combination with Pembrolizumab | Experimental | Drug: BDB001 (EIK1001), 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 BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, 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 (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Be 18 years of age on day of signing informed consent
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors who 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
- A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (27 listed)
- A woman of child bearing potential who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Prior exposure to TLR 7 agonists (e.g., GS-9620, imiquimod, TMX 101, resiquimod, MEDI9197, 825A) and TLR 9 agonists (e.g., SD-101, IMO2125, MGN1703, GNKG168, DUK-CPG-001 and CMP-001) for treatment of the solid tumor the patient is currently being evaluated for treatment with BDB001.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE
- Received previous therapy for malignancy within 21 days prior to administration of study drug, including any investigational agents (other than BDB001), chemotherapy, immunotherapy, biological or hormonal therapy (6 weeks for nitrosoureas or mitomycin C)
- Major surgery within 4 weeks of first dose of study drug
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 |
|---|---|---|
| BDB001 (EIK1001)BDB001 (EIK1001) is an immunotherapy agent. | Drug | BDB001 in Combination with Pembrolizumab, Single Agent BDB001 (EIK1001) |
| 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 | BDB001 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 BDB001 as a single agent 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 BDB001 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
5 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 BDB001 (EIK1001) and Pembrolizumab in people with Tumor, Solid, run by Eikon Therapeutics at 5 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 12 inclusion and 27 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 5 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; AzTrials last refreshed its copy on 6 Nov 2026.