Recruiting

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

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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 a treatment for people with Advanced Solid Tumors, which are types of cancer that have spread to other parts of the body. The study is testing a new combination of two medications: BI-1206 and Pembrolizumab. BI-1206 is a type of protein called a monoclonal antibody that targets a specific part of the immune system, while Pembrolizumab, also known as Keytruda, is a medication that helps the immune system fight cancer cells.

The purpose of the study is to find out how safe and tolerable the combination of these two medications is for patients with advanced solid tumors who have already been treated with other cancer therapies. Participants will receive BI-1206 either through an injection under the skin or through an infusion into a vein, along with Pembrolizumab given as an infusion. The study will gradually increase the dose of BI-1206 to determine the highest dose that can be given safely. The study will also look for any side effects and determine the best dose to use in future studies.

Throughout the study, participants will be closely monitored for any side effects and will have regular check-ups to assess their health. The study aims to identify any dose-limiting toxicities, which are side effects that prevent further dose increases, and to find the maximum tolerated dose of BI-1206 when used with Pembrolizumab. This research is important for developing new treatment options for people with advanced solid tumors who have not responded to previous treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will provide written consent and undergo initial assessments to confirm eligibility. This includes checking the performance status and organ function through laboratory tests.
Step 2
Screening and baseline assessments
A biopsy of the tumor tissue may be required before the first dose of the study medication. This biopsy should be from a non-irradiated lesion and performed at least four weeks after the last tumor-directed therapy.
Step 3
Treatment phase
The treatment involves the administration of two medications: BI-1206 and pembrolizumab.
BI-1206 is given either as a subcutaneous injection or an intravenous infusion. The dosage will be determined based on the patient's response and tolerance.
Pembrolizumab is administered as an intravenous infusion at a standard dose of 200 mg every three weeks.
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes documenting any adverse effects and conducting physical examinations and laboratory tests.
The study aims to identify the maximum tolerated dose of BI-1206 and observe any dose-limiting toxicities.
Step 5
Follow-up
After completing the treatment phase, follow-up visits will be scheduled to continue monitoring the patient's health and any long-term effects of the treatment.

Who can join the trial?

11 criteria

The patient must be willing and able to provide written consent to participate in the trial.
The patient should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
The patient must have adequate organ function, as confirmed by specific laboratory tests.
The patient must be at least 18 years old on the day they sign the consent form.
The patient must have a confirmed diagnosis of an advanced solid tumor, which means a type of cancer that forms in solid organs or tissues.
The patient must have received at least two doses of an approved anti-PD-1 or PD-L1 monoclonal antibody, which are types of cancer treatments, and have shown disease progression within 12 weeks of the last dose.
The patient must have received standard cancer treatment or be unable to tolerate it, refuse it, or not be eligible for it.
The patient must have at least one measurable disease lesion, which is a tumor that can be measured to assess the response to treatment.
The patient must be willing to undergo tissue biopsies, which are procedures to remove a small sample of tissue for examination, if required. However, if the doctor considers it unsafe or not possible, the biopsy will not be required.
The patient must have a life expectancy of at least 12 weeks.
For specific groups within the trial, additional criteria may apply, such as having received certain prior therapies or having specific genetic mutations.

Who cannot join the trial?

5 criteria

Patients who have not been previously treated with anti-PD1 or PDL1 antibodies. These are types of medicines used to help the immune system fight cancer.
Patients who do not have advanced solid tumors. A solid tumor is a mass of tissue that does not contain liquid areas or cysts.
Patients who are not experiencing disease progression. This means the cancer is not getting worse or spreading.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

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

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Centrul De Oncologie SF Nectarie S.R.L.
Craiova, Romania
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Hospital Universitario De Navarra
Pamplona, Spain
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Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Spain

Trial locations

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Investigated drugs

BI-1206
is a monoclonal antibody that targets a specific protein called CD32b. It is being tested to see if it can help the immune system fight cancer more effectively. In this trial, BI-1206 is given to patients with advanced solid tumors who have already been treated with other cancer therapies. The study aims to find out how safe and tolerable BI-1206 is when given in combination with another medication.
Pembrolizumab
is a medication that helps the immune system attack cancer cells. It is already used to treat various types of cancer. In this trial, pembrolizumab is given at a standard dose to patients with advanced solid tumors. The goal is to see if combining pembrolizumab with BI-1206 can improve treatment outcomes for patients who have not responded well to previous therapies.

What is already known about the treatment

BI-1206 – This medication is administered either intravenously or subcutaneously and is currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is a monoclonal antibody targeting CD32b, a receptor involved in immune regulation. The main therapeutic indication is for patients with advanced solid tumors who have previously been treated with anti-PD-1 or anti-PD-L1 antibodies. BI-1206 works by blocking the CD32b receptor, which may enhance the immune system's ability to attack cancer cells. It is classified as an immunotherapy agent.

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, spread to nearby tissues, or metastasize to distant organs. The progression of these tumors often leads to increased symptoms and complications, affecting the function of the involved organs. The growth and spread of these tumors can vary significantly depending on the type and location of the cancer. Understanding the behavior of advanced solid tumors is crucial for developing effective treatment strategies.