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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of BDB018, either alone or in combination with pembrolizumab, in people with advanced solid tumors.

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.Check my eligibility
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.See study design
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
Select...
My advanced cancer has worsened after all treatments, or I can't tolerate/refuse standard treatments.

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

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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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

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
5 Previous Clinical Trials
231 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,570 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been enrolled to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov contains evidence that this experiment is still recruiting participants, with recruitment beginning on June 22nd 2021 and the most recent update occurring July 30th 2021. The research team needs to recruit a total of 50 individuals from two distinct trial sites."

Answered by AI

Are there other empirical studies utilizing BDB018?

"Currently, there are 122 Phase 3 trials and 963 clinical studies being conducted with BDB018 as the primary focus. These experiments span across 35772 distinct locations around the world, particularly in Houston Texas."

Answered by AI

Are there currently vacancies for participants in this experiment?

"Precisely, clinicaltrials.gov provides evidence that this medical trial is actively enrolling patients. It was initially posted on June 22nd 2021 and recently revised on July 30th of the same year. The study requires 50 individuals to be recruited from 2 separate locations."

Answered by AI

What clinical applications is BDB018 employed in?

"BDB018 can be used to battle malignant neoplasms, non-operable melanomas, and microsatellite instability."

Answered by AI

Has BDB018 been sanctioned by the FDA?

"BDB018 has limited data supporting its safety and effectiveness, which is why it received a rating of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
2021. "Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840394.
~0 spots leftby Dec 2024
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