BDB018 + Pembrolizumab for Advanced Cancer

No longer recruiting at 2 trial locations

Overseen By Robert Andtbacka, MD,CM,

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Seven and Eight Biopharmaceuticals Inc

Must not be taking: TLR agonists

Disqualifiers: Local therapy candidates, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 63

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

My cancer can be measured by tests.

My advanced cancer has worsened after all treatments, or I can't tolerate/refuse standard treatments.

Evidence of progressive disease (PD) within 3 months of signing the informed consent form.

Exclusion Criteria

There may be additional requirements for participating in the study that are not listed here.

My condition can be treated with the goal of curing it.

I have been treated with TLR7, TLR8, or TLR9 drugs before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

21 days per cycle

Multiple visits per cycle

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

Up to 30 months

Every 63 days (3 cycles)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

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?

Group I: BDB018 in Monotherapy Experimental Treatment 1 Intervention

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.

Group II: BDB018 in Combination with Pembrolizumab Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Seven and Eight Biopharmaceuticals Inc

Lead Sponsor

Trials

5

Recruited

380+

Eikon Therapeutics

Lead Sponsor

Trials

8

Recruited

1,300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04840394

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 ...

2. withpower.com withpower.com/trial/phase-1-5-2021-94f1d

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.

3. businesswire.com businesswire.com/news/home/20211113005226/en/Seven-and-Eight-Biopharmas-BDB001-in-Combination-with-an-anti-PD-L1-mAb-Shows-Favorable-Safety-and-Clinical-Responses-in-Interim-Phase-1-Data-Presented-at-the-2021-SITC-Annual-Meeting

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 ...

4. researchgate.net researchgate.net/publication/352072683_BDB001_an_intravenously_administered_toll-like_receptor_7_and_8_TLR78_agonist_in_combination_with_pembrolizumab_in_advanced_solid_tumors_Phase_1_safety_and_efficacy_results

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9995514/

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 ...

6. firstwordpharma.com firstwordpharma.com/story/5441953

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980677/

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.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37678672/

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 ...