BDB018 + Pembrolizumab for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, BDB018 (an experimental treatment), both alone and with Pembrolizumab (an immunotherapy drug), for individuals with advanced solid tumors unresponsive to other treatments. Researchers aim to determine the optimal dose and assess the effectiveness of these treatments together. Individuals with advanced cancer that continues to progress despite other therapies might be suitable candidates. The trial seeks to provide more options for those who have exhausted effective treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that BDB018 is similar to BDB001 and aims to enhance the body's immune response against cancer while keeping side effects manageable. Studies of BDB001 combined with atezolizumab indicate it is generally well-tolerated and can effectively activate the immune system, suggesting BDB018 might be similarly safe.
For the combination of BDB018 and pembrolizumab, previous research on pembrolizumab alone has shown it is generally safe and tolerable at different doses for people with advanced cancer. Common side effects include tiredness and skin reactions, but these are usually manageable.
As a Phase 1 trial, the treatment is in the early testing stages. The main goal is to find safe dosage levels, so safety data is still being collected. Participants should know that the primary focus is on determining the treatment's safety and the optimal dose.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BDB018 in combination with Pembrolizumab for advanced cancer because it offers a different approach from existing treatments. Unlike traditional cancer therapies that often target cancer cells directly, BDB018 is designed to engage the immune system more effectively. This combination treatment may potentially enhance the body's natural defenses to recognize and destroy cancer cells more efficiently. Additionally, the use of Pembrolizumab, a well-known immunotherapy agent, in tandem with BDB018 aims to maximize the immune response, possibly leading to improved outcomes for patients with advanced cancer. Overall, this innovative strategy could provide new hope for patients who have exhausted current standard options.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
Research shows that BDB018 enhances the immune system's ability to attack cancer cells. In this trial, some participants will receive BDB018 as a monotherapy, while others will receive it in combination with pembrolizumab, known as Keytruda. Earlier studies with a similar drug, BDB001, yielded promising results, with some tumors shrinking and many patients' conditions remaining stable. Studies have also shown that pembrolizumab helps the immune system recognize and fight cancer cells, improving survival rates in various cancers. Combining BDB018 with pembrolizumab might further boost the immune response, potentially offering a new treatment option for people with advanced cancers.12678
Who Is on the Research Team?
Harry Raftopoulos, MD
Principal Investigator
Eikon Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have worsened within the last 3 months despite treatment, or who can't tolerate or refuse standard treatments. They must have measurable disease and not have been treated with TLR7, TLR8, dual agonists, or TLR9 agonists before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive BDB018 in monotherapy or in combination with pembrolizumab following a 3+3 dose escalation design to determine the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Dose Expansion
Approximately twenty additional subjects are enrolled to further evaluate the safety and efficacy of BDB018 in combination with pembrolizumab at the determined MTD or RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BDB018
- Pembrolizumab
Trial Overview
The study is testing BDB018 on its own and combined with Pembrolizumab in patients. It's a Phase 1 trial to find out the right dose of BDB018 and see how safe it is when given alone or with Pembrolizumab to people with advanced solid tumors.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seven and Eight Biopharmaceuticals Inc
Lead Sponsor
Eikon Therapeutics
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
NCT04840394 | Clinical Study of BDB018: Monotherapy ...
The primary objectives of this study are to evaluate the safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab (Keytruda) in ...
BDB018 + Pembrolizumab for Advanced Cancer
It aims to help patients with advanced cancers that don't respond to other treatments. BDB018 works by boosting the immune system to better attack cancer cells.
Seven and Eight Biopharma's BDB001 in Combination with ...
The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in ...
BDB001, an intravenously administered toll-like receptor 7 ...
Efficacy data were available for 32 clinical trial participants, of whom 6% (n = 2) had a partial response (PR) and 56% (n = 20) had SD. A total of 23 patients ...
Applications and clinical trial landscape using Toll-like ...
Efficacy data were available for 32 clinical trial participants, of whom 6% (n = 2) had a partial response (PR) and 56% (n = 20) had SD. A total ...
Seven and Eight Biopharma's BDB001 in Combination with ...
The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in ...
Trial watch: Toll-like receptor ligands in cancer therapy - PMC
BDB018 is an analog of BDB001 designed to further enhance immune activation against cancer, while maintaining a favorable safety profile.
EV-301 long-term outcomes: 24-month findings from the ...
Introduction: This exploratory analysis evaluated efficacy and safety data for enfortumab vedotin versus chemotherapy over a median follow-up of ∼2 years from ...
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