In short
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.
At a glance
- 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
What is BI-1910?
BI-1910 is a new monoclonal antibody that is currently being studied as a potential treatment for advanced solid tumors. 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). 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.
- Hepatocellular Carcinoma (HCC): This is the most common type of primary liver cancer, which starts in the main type of liver cell (hepatocyte).
- Other advanced or metastatic solid tumors: These are cancers that have spread from where they started to other parts of the body.
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. The trial has several parts:
- Phase 1, Part A: This part tests BI-1910 alone to find the right dose and check its safety.
- Phase 1, Part B: This part tests BI-1910 in combination with another drug called pembrolizumab.
- Phase 2a, Part A: This part further tests BI-1910 alone at the dose determined in Phase 1.
- Phase 2a, Part B: This part tests BI-1910 with pembrolizumab at the doses determined in Phase 1.
How is BI-1910 Administered?
BI-1910 is given as an intravenous (IV) infusion once every 3 weeks. 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). 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.
- Duration of Response (DoR): This is how long the cancer stays smaller or gone after it responds to treatment.
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.