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Bi-1910

A groundbreaking clinical trial is underway to evaluate the effectiveness and safety of BI-1910, a new drug designed to target advanced solid tumors. This study aims to assess BI-1910 both as a standalone treatment and in combination with pembrolizumab, a known immunotherapy drug. The trial focuses on patients with advanced or metastatic solid tumors, including non-small cell lung cancer and hepatocellular carcinoma, whose conditions have not improved with standard treatments. This research could potentially open new doors for cancer treatment, offering hope to patients with limited options.

Table of Contents

What is BI-1910?

BI-1910 is a new monoclonal antibody that is currently being studied as a potential treatment for advanced solid tumors[1]. Monoclonal antibodies are laboratory-made proteins that act like human antibodies in the immune system. They are designed to recognize and attach to specific proteins found on cancer cells.

How Does BI-1910 Work?

BI-1910 targets a specific protein called Tumor Necrosis Factor Receptor 2 (TNFR2)[1]. TNFR2 is found on certain types of cancer cells and immune cells. By targeting this protein, BI-1910 may help the immune system recognize and attack cancer cells more effectively.

What Conditions Does BI-1910 Treat?

BI-1910 is being studied for the treatment of several types of advanced solid tumors, including:

  • Non-Small Cell Lung Cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers[1].
  • Hepatocellular Carcinoma (HCC): This is the most common type of primary liver cancer, which starts in the main type of liver cell (hepatocyte)[1].
  • Other advanced or metastatic solid tumors: These are cancers that have spread from where they started to other parts of the body[1].

Current Clinical Trial

BI-1910 is currently being studied in a Phase 1/2a clinical trial. This is an early-stage trial designed to test the safety and effectiveness of the drug[1]. The trial has several parts:

  1. Phase 1, Part A: This part tests BI-1910 alone to find the right dose and check its safety[1].
  2. Phase 1, Part B: This part tests BI-1910 in combination with another drug called pembrolizumab[1].
  3. Phase 2a, Part A: This part further tests BI-1910 alone at the dose determined in Phase 1[1].
  4. Phase 2a, Part B: This part tests BI-1910 with pembrolizumab at the doses determined in Phase 1[1].

How is BI-1910 Administered?

BI-1910 is given as an intravenous (IV) infusion once every 3 weeks[1]. This means the drug is delivered directly into your bloodstream through a vein. When combined with pembrolizumab, the pembrolizumab is given first, followed by BI-1910.

Safety and Side Effects

As this is an early-stage trial, one of the main goals is to assess the safety of BI-1910. The researchers are carefully monitoring for any side effects, which they call adverse events (AEs) or serious adverse events (SAEs)[1]. They’re also watching for:

  • How often the treatment needs to be interrupted or the dose reduced
  • Changes in laboratory test results
  • Changes in vital signs like temperature, blood pressure, and oxygen levels
  • Any severe side effects that might limit the dose that can be given (called dose-limiting toxicities)

Future Prospects

The researchers are also looking at how well BI-1910 works against cancer. They’re measuring this in several ways:

  • Objective Response Rate (ORR): This is the percentage of patients whose cancer shrinks or disappears after treatment[1].
  • Duration of Response (DoR): This is how long the cancer stays smaller or gone after it responds to treatment[1].

If BI-1910 shows promising results in this early trial, it may be studied further in larger trials. This could eventually lead to it becoming an approved treatment for certain types of advanced solid tumors.

Aspect Details
Drug Name BI-1910
Drug Type Monoclonal antibody targeting Tumor Necrosis Factor Receptor 2 (TNFR2)
Trial Phase Phase 1/2a
Trial Design Open-label, dose-escalation, multicenter, first-in-human, consecutive-cohort
Target Conditions Advanced/metastatic solid tumors, including Non-Small Cell Lung Cancer and Hepatocellular Carcinoma
Administration Intravenous infusion every 3 weeks
Combination Therapy Tested alone and in combination with pembrolizumab
Primary Outcomes Safety, tolerability, maximum tolerated dose, recommended dose for future trials
Secondary Outcomes Pharmacokinetics, antidrug antibodies, objective response rate, duration of response
Trial Duration Up to 2 years of treatment with 90 days follow-up

FAQ

  • What is BI-1910 and how does it work? BI-1910 is a monoclonal antibody that targets Tumor Necrosis Factor Receptor 2 (TNFR2). It's designed to fight advanced solid tumors by interacting with this specific receptor on cancer cells. The exact mechanism is still being studied, but it's believed to help the immune system better recognize and attack cancer cells.
  • Who can participate in this clinical trial? This trial is for patients with advanced or metastatic solid tumors, including non-small cell lung cancer and hepatocellular carcinoma (liver cancer). Participants should have already tried standard treatments without success. The trial aims to help patients whose cancer has continued to progress despite previous therapies.
  • How is the drug administered in the trial? BI-1910 is given as an intravenous (IV) infusion once every 3 weeks. In some parts of the trial, it's combined with pembrolizumab, which is also given as an IV infusion at its standard dose of 200 mg, also every 3 weeks. The pembrolizumab infusion is given before the BI-1910 infusion when they're used together.
  • What are the main goals of this clinical trial? The main goals are to determine how safe and tolerable BI-1910 is, find the best dose for future trials, and see if it shows any early signs of effectiveness against tumors. The researchers will look at side effects, how the body processes the drug, and whether tumors shrink or stop growing in response to the treatment.
  • How long does the trial last and what kind of follow-up is involved? The trial can last up to 2 years of treatment, with an additional 90 days of follow-up after treatment ends. During this time, participants will have regular check-ups to monitor their health, assess side effects, and measure how their tumors are responding to the treatment. Various tests, including blood work and imaging scans, will be performed throughout the study period.

Ongoing Clinical Trials on Bi-1910

  • Study on BI-1910 and Pembrolizumab for Patients with Advanced Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Denmark Germany Poland Spain Sweden

Glossary

  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In cancer treatment, monoclonal antibodies can be used to carry drugs, toxins, or radioactive substances directly to cancer cells.
  • Tumor Necrosis Factor Receptor 2 (TNFR2): A protein found on the surface of certain cells that can receive signals to promote cell survival or death. In some cancers, TNFR2 may help tumor cells survive and grow.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells. It's already approved for use in several types of cancer.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Intravenous (IV) Infusion: A way of giving medication through a needle or tube inserted directly into a vein, allowing the drug to enter the bloodstream quickly.
  • Dose Escalation: A method used in clinical trials where the dose of a drug is gradually increased to find the best balance between its effectiveness and side effects.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Dose Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose to be reduced in a clinical trial.

References

  1. https://clinicaltrials.gov/study/NCT06205706