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

1 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Hospital Universitario Virgen Macarena	Sevilla	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Saarland University Hospital	Homburg	Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
HM Malaga	Malaga	Spain
Icbxabko Cvhmno Dblnhkwvwlsksuawp	L'hospitalet De Llobregat	Spain
Ngkvxunt Iyfxmgsx Olaswutxz Ida Mqldy Sgumhficjdmnvfylvbmkxsofdinq Ieerjbnh Binxquos	Cracow	Poland
Hgazqjjm Vgrq dqzvvghj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.01.2020
Poland	Recruiting	01.01.2020
Romania	Recruiting	01.01.2020
Spain	Recruiting	01.01.2020
Sweden	Recruiting	01.01.2020

Trial locations

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.

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.

Trial ID:

2023-509846-36-00

Protocol code:

18-BI-1206-03

NCT ID:

NCT04219254

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?