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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for advanced solid tumors, which are types of cancer that have spread beyond their original location. The study will explore the effects of a new treatment called BI-1910, a monoclonal antibody that targets a specific protein involved in cancer growth. This treatment will be tested both on its own and in combination with another medication called pembrolizumab, which is already used to treat certain cancers. Pembrolizumab is known by the brand name Keytruda and works by helping the immune system fight cancer cells.

The purpose of the study is to assess the safety and tolerability of BI-1910 alone and with pembrolizumab in patients with advanced solid tumors. The trial will be conducted in two phases. In the first phase, researchers will determine the safest dose of BI-1910 that can be given to patients, both alone and with pembrolizumab. In the second phase, the study will identify the most effective dose for future research. Participants will receive the study treatments and be monitored for any side effects or changes in their health. The study will also look at how the body processes the medications and how the immune system responds to them.

Throughout the trial, participants will undergo regular health checks, including blood tests and other assessments, to ensure their safety and to gather information on how the treatments are working. The study aims to provide valuable insights into the potential benefits and risks of using BI-1910 and pembrolizumab for treating advanced solid tumors, which could lead to new treatment options for patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the presence of advanced solid tumors.
A biopsy may be required to provide a sample of the tumor tissue. This is done before the first dose of the study medication.
Step 2
Phase 1 treatment
The first phase involves receiving the medication BI-1910 alone. This is administered through an intravenous infusion.
The goal is to determine the maximum safe dose. Monitoring for any side effects is crucial during this phase.
Step 3
Combination treatment
If the initial phase is tolerated well, the treatment may include a combination of BI-1910 and pembrolizumab (also known as Keytruda).
This combination is also administered intravenously, and the focus is on assessing safety and determining the appropriate dose for future studies.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to track any changes in health status, including laboratory tests and physical examinations.
The occurrence of any adverse effects is recorded, and adjustments to the treatment may be made if necessary.
Step 5
Phase 2a treatment
In this phase, the recommended dose from the previous phases is used to further evaluate the treatment's effectiveness.
The focus is on measuring the response rate and duration of response to the treatment.
Step 6
Completion and final assessment
Upon completion of the trial, a final assessment is conducted to evaluate the overall impact of the treatment.
This includes a comprehensive review of all collected data to determine the treatment's safety and effectiveness.

Who can join the trial?

9 criteria

The patient must be willing and able to sign a form that shows they agree to participate in the trial. If they do not agree to genetic testing, they can still join the trial.
The patient must be at least 18 years old on the day they sign the consent form.
The patient must have a type of cancer called an advanced or metastatic solid tumor, which means the cancer has spread to other parts of the body.
The patient must have already tried standard treatments for their cancer, but these treatments did not work, or they could not tolerate them, or they are not eligible for these treatments.
The patient must have at least one area of cancer that can be measured to see if the treatment is working, as defined by a set of guidelines called RECIST v1.1.
The patient must be willing to provide samples of their tumor for testing, unless there is a medical reason they cannot. This includes a sample taken before starting the trial, at least 4 weeks after their last cancer treatment. If a new sample cannot be taken, an older sample from a previous biopsy may be used if it was taken after their last treatment and before joining the trial.
The patient must have a life expectancy of at least 12 weeks.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have organs that are working well, as shown by lab tests.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with advanced solid tumors. These are types of cancer that form in solid organs or tissues and have progressed to a more severe stage.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not able to safely tolerate the study medication or its combination with other treatments.
Patients who are part of a vulnerable population that may require special protection or considerations.
Patients who do not meet other specific health criteria set by the study organizers.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Karolinska University Hospital
Solna, Sweden

Trial locations

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Investigated drugs

BI 1910
is a monoclonal antibody designed to target and block the Tumor Necrosis Factor Receptor 2 (TNFR2). This receptor is often found on the surface of certain cancer cells and can help them grow and survive. By blocking TNFR2, BI 1910 aims to stop the growth of these cancer cells and potentially shrink tumors. This medication is being tested both on its own and in combination with another drug to see how well it works and how safe it is for patients with advanced solid tumors.
Pembrolizumab
is a type of cancer treatment known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells. Pembrolizumab blocks a specific protein on the surface of immune cells, which can prevent them from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to better target and destroy cancer cells. In this trial, it is being used in combination with BI 1910 to see if the two drugs together can more effectively treat advanced solid tumors.

Pembrolizumab

What is already known about the treatment

BI 1910 – This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is a monoclonal antibody targeting the Tumor Necrosis Factor Receptor 2 (TNFR2), which plays a role in regulating immune responses. By binding to TNFR2, BI 1910 may help to modulate the immune system's ability to fight cancer cells. It is classified as an immunotherapy agent and is being evaluated both as a standalone treatment and in combination with pembrolizumab, another immunotherapy drug.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors often leads to increased symptoms, which can include pain, fatigue, and organ dysfunction, depending on the tumor's location. The complexity of advanced solid tumors often requires a comprehensive approach to management and care.