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Bi-1808

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.

Table of Contents

What is BI-1808?

BI-1808 is a new medication being studied for the treatment of advanced cancers[1]. 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[1].

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[1].

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[1].

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:

  1. Determine the safety and tolerability of BI-1808
  2. Find the best dose to use in future studies
  3. See how the drug behaves in the body (pharmacokinetics)
  4. Look for early signs of effectiveness against cancer

The study is divided into several parts, each looking at different aspects of the treatment[1].

BI-1808 Alone and in Combination

The clinical trial is testing BI-1808 in two ways:

  1. As a single agent: This means BI-1808 is given on its own to see how it works.
  2. 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[1].

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[1].

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[1].

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[1].

Aspect Details
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

FAQ

  • What is the main goal of this clinical trial? The main goal is to test BI-1808, both alone and combined with pembrolizumab, in patients with advanced cancers that have not responded to standard treatments. The trial aims to determine how safe and tolerable BI-1808 is, find the maximum dose that can be given safely, and establish the recommended dose for future clinical trials.
  • How is the medication administered in this trial? Both BI-1808 and pembrolizumab are given as intravenous (IV) infusions once every 3 weeks. The dosage of BI-1808 will be adjusted throughout the trial to find the best dose.
  • What types of cancer are being studied in this trial? The trial focuses on advanced malignancies, which includes advanced solid tumors and T-cell lymphoma (TCL). Specific conditions mentioned are ovarian cancer, melanoma, and T-cell lymphoma.
  • How long does the trial last? The trial can last up to 104 weeks (2 years) for each participant. During this time, researchers will monitor patients' responses to the treatment and any side effects.
  • What are the main things researchers will be measuring? Researchers will primarily be looking at the occurrence of side effects (both mild and serious), how the body processes the drug (pharmacokinetics), the body's immune response to the drug, and how well the drug binds to its target (TNFR2 receptor occupancy). They will also assess early signs of the treatment's effectiveness against the cancer.

Ongoing Clinical Trials on Bi-1808

  • Study on BI-1808 and Pembrolizumab for Patients with Advanced Solid Tumors

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark Hungary Spain Sweden

Glossary

  • BI-1808: A monoclonal antibody that targets TNFR2 (Tumor Necrosis Factor Receptor 2), being studied as a potential treatment for advanced cancers.
  • Pembrolizumab (KEYTRUDA®): An immunotherapy drug already in use that helps the immune system fight cancer cells.
  • Advanced Malignancies: Cancers that have spread beyond their original location or are not responding to standard treatments.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. It's used in cancer treatment to help the immune system fight cancer.
  • TNFR2: Tumor Necrosis Factor Receptor 2, a protein found on certain cells that BI-1808 targets.
  • Intravenous (IV) Infusion: A method of delivering medication directly into a vein using a needle or catheter.
  • Dose Escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • RP2D: Recommended Phase 2 Dose, the dose determined to be most appropriate for further testing based on safety and effectiveness.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References