In short
A groundbreaking clinical trial is underway to assess the safety and efficacy of BI-1808, a new monoclonal antibody targeting TNFR2, in patients with advanced malignancies. This study aims to explore BI-1808 both as a standalone treatment and in combination with pembrolizumab (KEYTRUDA®), a well-known immunotherapy drug. The trial seeks to determine the optimal dosage and potential benefits for patients whose cancer has progressed despite standard treatments.
At a glance
- Study Type
- Phase 1/2a, open-label, dose-escalation, multicenter clinical trial
- Drug Studied
- BI-1808 (alone and in combination with pembrolizumab)
- Target Conditions
- Advanced malignancies (solid tumors, T-cell lymphoma, ovarian cancer, melanoma)
- Primary Objectives
- Assess safety, tolerability, determine maximum tolerated dose, select recommended Phase 2 dose
- Secondary Objectives
- Evaluate pharmacokinetics, antibody response, receptor occupancy
- Treatment Schedule
- Intravenous infusions every 3 weeks
- Study Duration
- Up to 104 weeks (2 years) per participant
What is BI-1808?
BI-1808 is a new medication being studied for the treatment of advanced cancers. It is classified as a monoclonal antibody, which is a type of laboratory-made protein designed to target specific cells in the body. In this case, BI-1808 is a fully human immunoglobulin G1 (IgG1) monoclonal antibody that targets a protein called TNFR2.
How Does BI-1808 Work?
BI-1808 works by targeting TNFR2, which stands for Tumor Necrosis Factor Receptor 2. This protein is found on certain cells in the body, including some cancer cells and immune cells. By binding to TNFR2, BI-1808 may help the immune system recognize and attack cancer cells more effectively.
What Conditions Does BI-1808 Treat?
BI-1808 is being studied for the treatment of advanced malignancies. This term refers to cancers that have spread or become difficult to treat with standard therapies. Specifically, the clinical trial is focusing on:
- Advanced solid tumors: These are cancers that form solid masses in organs or tissues
- Non-small cell lung cancer (NSCLC): A common type of lung cancer
- Ovarian cancer (OC): Cancer that begins in the ovaries
- Cutaneous T-cell lymphoma (CTCL): A rare type of cancer that affects the skin, specifically:
- Sézary Syndrome (SS): A type of CTCL that affects the blood and skin
- Mycosis Fungoides (MF): The most common form of CTCL, primarily affecting the skin
The study is particularly interested in patients whose cancer has progressed after standard treatments.
Clinical Trial Overview
The clinical trial for BI-1808 is a Phase 1/2a study, which means it's in the early stages of testing in humans. The main goals of this trial are to:
- Determine the safety and tolerability of BI-1808
- Find the best dose to use in future studies
- See how the drug behaves in the body (pharmacokinetics)
- Look for early signs of effectiveness against cancer
The study is divided into several parts, each looking at different aspects of the treatment.
BI-1808 Alone and in Combination
The clinical trial is testing BI-1808 in two ways:
- As a single agent: This means BI-1808 is given on its own to see how it works.
- In combination with pembrolizumab: Pembrolizumab (brand name KEYTRUDA®) is another immunotherapy drug that's already approved for various cancers. The study is looking at whether combining these two drugs might be more effective than either one alone.
Safety and Side Effects
A major focus of this study is to assess the safety of BI-1808. The researchers are carefully monitoring for any side effects or adverse events that might be related to the treatment. They're also looking for what's called "dose-limiting toxicities" (DLTs), which are side effects severe enough to limit how much of the drug can be given safely.
What to Expect During Treatment
If you were to participate in this clinical trial, here's what you might expect:
- BI-1808 is given as an intravenous (IV) infusion, which means it's delivered directly into your bloodstream through a vein.
- Treatments are typically given every 3 weeks.
- You would have regular check-ups and tests to monitor your health and the effects of the treatment.
- The initial treatment period is about 9 weeks, after which doctors will assess if the treatment is helping.
- If the treatment appears to be working, you may continue receiving it for longer.
It's important to note that as this is a clinical trial, not all patients will receive the same treatment. Some may receive BI-1808 alone, while others might receive it in combination with pembrolizumab. The exact treatment plan would depend on which part of the study you're in.