Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04840394|
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : August 3, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Tumor, Solid||Drug: BDB018 Drug: Pembrolizumab||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 22, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||December 2023|
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.
BDB018 is an immunotherapy agent.
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.
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840394
|Contact: Robert Andtbacka, MD,CM,||email@example.com|
|Contact: Melissa Harneyfirstname.lastname@example.org|
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34230|
|Contact: Seven and Eight Biopharma 848-300-0086|
|Principal Investigator: Manish Patel, MD|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49501|
|Contact: Seven and Eight Biopharmaceuticals|
|Principal Investigator: Manish Sharma, MD|
|Study Chair:||Robert Andtbacka, MD, CM,||Seven and Eight Biopharmaceuticals Inc|
|Responsible Party:||Seven and Eight Biopharmaceuticals Inc|
|Other Study ID Numbers:||
|First Posted:||April 12, 2021 Key Record Dates|
|Last Update Posted:||August 3, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
TLR 7/8 Agonist
Antineoplastic Agents, Immunological