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Unknown

BDB018 + Pembrolizumab for Advanced Cancer

Phase 1
Waitlist Available
Research Sponsored by Seven and Eight Biopharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new drug called BDB018, both by itself and with another drug called pembrolizumab. 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. Pembrolizumab is a humanized antibody approved for the treatment of various types of cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood tests affecting organs like liver and kidneys. Side effects may vary between monotherapy and combination therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has worsened after all treatments, or I can't tolerate/refuse standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition can be treated with the goal of curing it.
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I have been treated with TLR7, TLR8, or TLR9 drugs before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
Secondary study objectives
Determine Maximum Tolerated Dose
Radiographic Determination of Tumor Response after BDB018 Dosing

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BDB018 in MonotherapyExperimental Treatment1 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 PembrolizumabExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include immune checkpoint inhibitors such as Pembrolizumab, which is a PD-1 inhibitor. These treatments work by blocking the PD-1 pathway, a mechanism that tumors use to evade the immune system. By inhibiting this pathway, Pembrolizumab allows the immune system to recognize and attack cancer cells more effectively. Understanding these mechanisms is crucial for patients with solid tumors because it highlights the importance of the immune system in fighting cancer and helps in anticipating potential side effects and the overall effectiveness of the treatment.
Paradigms on Immunotherapy Combinations with Chemotherapy.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Nivolumab Immunotherapy in Malignant Mesothelioma: A Case Report Highlighting a New Opportunity for Exceptional Outcomes.

Find a Location

Who is running the clinical trial?

Seven and Eight Biopharmaceuticals IncLead Sponsor
4 Previous Clinical Trials
338 Total Patients Enrolled
Eikon TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,218 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,802 Total Patients Enrolled

Media Library

BDB018 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04840394 — Phase 1
Solid Tumors Research Study Groups: BDB018 in Monotherapy, BDB018 in Combination with Pembrolizumab
Solid Tumors Clinical Trial 2023: BDB018 Highlights & Side Effects. Trial Name: NCT04840394 — Phase 1
BDB018 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840394 — Phase 1
~0 spots leftby Dec 2025