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Anti-(Fc Fragment Of Igg Receptor Iib) Monoclonal Antibody Bi-1206

Two clinical trials are currently investigating the use of BI-1206, a novel monoclonal antibody targeting CD32b (FcγRIIB), in combination with other cancer therapies. One study focuses on patients with advanced solid tumors, while the other targets indolent B-cell non-Hodgkin lymphoma. These trials aim to assess the safety, efficacy, and optimal dosing of BI-1206 in combination with established cancer treatments, potentially offering new options for patients with difficult-to-treat cancers.

Table of Contents

What is BI-1206?

BI-1206 is a new type of medication called a monoclonal antibody. It is specifically designed to target a protein called CD32b (also known as FcγRIIB) found on certain immune cells[1]. This medication is currently being studied as a potential treatment for various types of cancer, particularly advanced solid tumors and certain types of lymphoma.

How does BI-1206 work?

BI-1206 works by binding to the CD32b protein on immune cells, particularly B cells. This protein normally acts as a “brake” on the immune system, preventing it from becoming overactive. By blocking CD32b, BI-1206 aims to release this brake and enhance the body’s natural immune response against cancer cells[1][2].

What conditions does BI-1206 treat?

BI-1206 is being investigated for the treatment of several types of cancer:

  • Advanced Solid Tumors: These are cancers that form solid masses in various parts of the body, such as lung, breast, or colon cancer[1].
  • Indolent B-Cell Non-Hodgkin Lymphoma: This is a slow-growing type of blood cancer that affects B cells, a type of white blood cell. Specific subtypes being studied include:
    • Follicular Lymphoma (FL)
    • Marginal Zone Lymphoma (MZL)
    • Mantle Cell Lymphoma (MCL)[2]

Current Clinical Trials

BI-1206 is currently being studied in two main clinical trials:

  1. Advanced Solid Tumors Trial: This is a Phase 1/2a study combining BI-1206 with another immunotherapy drug called pembrolizumab. It’s designed for patients with advanced solid tumors who have already tried other treatments, including immunotherapy[1].
  2. B-Cell Non-Hodgkin Lymphoma Trial: This is also a Phase 1/2a study, but it combines BI-1206 with rituximab (another type of antibody therapy), with or without a drug called acalabrutinib. This trial is for patients with slow-growing B-cell lymphomas that have either not responded to previous rituximab treatment or have come back after treatment[2].

How is BI-1206 administered?

BI-1206 can be given in two ways:

  • Intravenous (IV) infusion: The medication is given directly into a vein.
  • Subcutaneous (SC) injection: The medication is injected under the skin[1][2].

The exact dosing and schedule will depend on the specific clinical trial and the individual patient’s needs.

Potential Side Effects

As BI-1206 is still in clinical trials, all of its potential side effects are not yet known. However, common side effects of monoclonal antibody treatments can include:

  • Infusion-related reactions
  • Fatigue
  • Nausea
  • Skin rash
  • Changes in blood cell counts[1][2]

It’s important to note that the clinical trials are closely monitoring patients for any adverse effects to ensure safety.

Future Prospects

BI-1206 represents a promising new approach in cancer treatment. By enhancing the body’s own immune response against cancer cells, it may offer hope for patients who have not responded well to other treatments. However, it’s important to remember that BI-1206 is still in the experimental stage. More research is needed to fully understand its effectiveness and safety profile[1][2].

If you’re interested in learning more about BI-1206 or the ongoing clinical trials, it’s best to speak with your healthcare provider. They can provide more information and help determine if participating in a clinical trial might be appropriate for your specific situation.

Aspect Solid Tumor Trial Lymphoma Trial
Study Type Phase 1/2a Phase 1/2a
Target Population Advanced solid tumors Indolent B-cell non-Hodgkin lymphoma
Combination Therapy BI-1206 + Pembrolizumab BI-1206 + Rituximab (± Acalabrutinib)
Administration Routes Intravenous or Subcutaneous Intravenous or Subcutaneous
Primary Objectives Safety, tolerability, MTD, RP2D Safety, tolerability, MTD, RP2D
Secondary Objectives Pharmacokinetics, immunogenicity, receptor occupancy Pharmacokinetics, immunogenicity, B-cell depletion, anti-tumor activity

FAQ

  • What is BI-1206? BI-1206 is a monoclonal antibody that targets CD32b (FcγRIIB), a protein found on certain immune cells. It is being studied as a potential treatment for various types of cancer, including advanced solid tumors and non-Hodgkin lymphoma.
  • What types of cancer are being studied in these clinical trials? The clinical trials are studying BI-1206 in patients with advanced solid tumors (such as non-small cell lung cancer and melanoma) and indolent B-cell non-Hodgkin lymphoma (including follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma).
  • How is BI-1206 administered in these trials? BI-1206 is administered either intravenously (through a vein) or subcutaneously (under the skin). The trials are testing different doses and administration methods to determine the most effective and safe approach.
  • What other drugs are being used in combination with BI-1206? In the solid tumor trial, BI-1206 is combined with pembrolizumab. In the lymphoma trial, it is combined with rituximab, with or without acalabrutinib. These combinations aim to enhance the effectiveness of cancer treatment.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety and tolerability of BI-1206 in combination with other cancer drugs, determine the optimal dose, evaluate how the drug behaves in the body (pharmacokinetics), and measure its potential anti-tumor activity in patients with advanced cancers.

Ongoing Clinical Trials on Anti-(Fc Fragment Of Igg Receptor Iib) Monoclonal Antibody Bi-1206

  • Study of BI-1206 and Pembrolizumab for Patients with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland Romania Spain Sweden

  • Study of BI-1206, Rituximab, and Acalabrutinib for Patients with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany Spain

Glossary

  • Monoclonal antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. Monoclonal antibodies are used to treat some types of cancer.
  • CD32b (FcγRIIB): A protein found on certain immune cells that BI-1206 targets. It plays a role in regulating immune responses.
  • Advanced solid tumors: Cancers that form solid masses and have spread beyond their original location or are at an advanced stage.
  • Non-Hodgkin lymphoma: A type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.
  • Intravenous (IV): A method of administering medication directly into a vein.
  • Subcutaneous (SC): A method of administering medication by injecting it under the skin.
  • Pembrolizumab: An immunotherapy drug that helps the immune system fight cancer cells.
  • Rituximab: A monoclonal antibody used to treat certain types of blood cancers, including non-Hodgkin lymphoma.
  • Acalabrutinib: A targeted therapy drug used to treat certain types of blood cancers.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent increasing the dose of a drug in a clinical trial.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose of a drug selected for further testing in Phase 2 clinical trials, based on safety and efficacy data from Phase 1 trials.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.

References

  1. http://clinicaltrials.eu/trial/study-of-bi-1206-and-pembrolizumab-for-patients-with-advanced-solid-tumors-previously-treated-with-anti-pd-1-or-anti-pd-l1-therapy/
  2. http://clinicaltrials.eu/trial/study-of-bi-1206-rituximab-and-acalabrutinib-for-patients-with-relapsed-or-refractory-indolent-b-cell-non-hodgkin-lymphoma/