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Study of MDNA11 Alone or with 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 patients with Advanced Solid Tumors, which are types of cancer that have spread beyond their original location. The study will explore the effects of two treatments: MDNA11 and pembrolizumab. MDNA11 is an engineered protein designed to boost the immune system, while pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system recognize and attack cancer cells. The purpose of the study is to evaluate the safety and effectiveness of these treatments, both when used alone and in combination.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will begin with a phase where different doses of MDNA11 are tested to find the most suitable dose. This will be followed by a phase where the treatment's ability to fight cancer is further assessed. Throughout the study, researchers will monitor participants closely to understand how the treatments affect the body and to identify any side effects.

The study aims to gather information on how well these treatments work against Advanced Solid Tumors and to determine the best way to use them. The results will help in deciding the recommended dose and schedule for MDNA11 and will provide early insights into the potential benefits of combining it with pembrolizumab. This research is an important step in developing new treatment options for patients with advanced cancer.

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
Joining the study
Upon joining the study, the patient will undergo initial assessments to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure adequate organ function and overall health status.
Step 2
Treatment initiation
The patient will begin treatment with MDNA11, which is administered as a solution for infusion through an intravenous line. The dosage will be determined based on the dose escalation phase of the study.
If participating in the combination therapy group, the patient will also receive pembrolizumab (Keytruda), another solution for infusion, administered intravenously.
Step 3
Dose escalation phase
During this phase, the patient will receive increasing doses of MDNA11 to determine the recommended dose for expansion (RDE) and the maximum tolerable dose (MTD).
The safety and tolerability of the treatment will be closely monitored through regular check-ups, laboratory tests, and assessments of any side effects.
Step 4
Dose expansion phase
Once the RDE and MTD are established, the patient will continue to receive MDNA11 at the determined dose. If in the combination group, pembrolizumab will also be administered.
The focus will be on further evaluating the safety and effectiveness of the treatment, including its impact on tumor size and progression.
Step 5
Ongoing assessments
Throughout the study, the patient will undergo regular assessments to monitor the treatment's effects. This includes imaging tests like CT or MRI scans to evaluate tumor response, as well as blood tests to check for any changes in health status.
The patient will also be asked to report any side effects or changes in symptoms.
Step 6
Study completion
At the end of the study, the patient will have a final assessment to evaluate the overall impact of the treatment. This will include a comprehensive review of all collected data and any remaining side effects.
The patient will be informed about the next steps, including any follow-up care or additional treatments that may be necessary.

Who can join the trial?

12 criteria

You must be at least 18 years old.
If you are a woman who can have children, you must have a negative pregnancy test before starting the study and must not be breastfeeding.
You must agree to use effective birth control methods during the study and for at least 6 months after the last dose of the study drug. Men must agree not to donate sperm during this time.
If you are HIV positive, you must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection. This means having a certain level of immune cells and keeping the virus under control for at least 12 weeks before the study.
You must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures your ability to carry out daily activities.
You must be willing to provide written consent to participate in the study and follow all study procedures.
You must have a confirmed diagnosis of a locally advanced or metastatic solid tumor.
You must agree to provide your medical history, including any available blood and tumor marker information.
You must consent to provide tissue samples from previous treatments if available, for further study.
You must have adequate organ function, which includes specific blood cell counts, liver function, and kidney function, as defined by the study.
You must have measurable disease according to specific criteria, which means the tumor can be measured accurately using scans like CT or MRI.
You must have an expected life expectancy of at least 12 weeks at the time of giving consent to participate in the study.

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.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

MDNA11
is a medication being studied for its potential to treat advanced solid tumors. It is a modified version of a protein that can help stimulate the immune system to fight cancer. In this trial, researchers are testing MDNA11 both as a standalone treatment and in combination with another medication to see how well it works and how safe it is for patients.
Pembrolizumab
is an immune checkpoint inhibitor used in this study in combination with MDNA11. It works by helping the immune system recognize and attack cancer cells more effectively. The trial aims to determine if combining pembrolizumab with MDNA11 enhances the treatment's effectiveness against advanced solid tumors.

What is already known about the treatment

MDNA11 – MDNA11 is an investigational medication administered through injection, currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is in the early stages of research, with ongoing studies evaluating its safety, tolerability, and effectiveness both as a standalone treatment and in combination with the immune checkpoint inhibitor pembrolizumab. The main therapeutic indication for MDNA11 is advanced solid tumors, where it aims to enhance the body's immune response against cancer cells. At the molecular level, MDNA11 is designed to act as an IL-2 superkine, which means it modifies the activity of interleukin-2, a protein that plays a crucial role in regulating the immune system. It falls under the pharmacological classification of immunotherapy agents, specifically targeting immune modulation to fight cancer.

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 the disease advances, the tumors may grow larger, spread to nearby tissues, or metastasize to distant organs. The progression of these tumors can lead to a range of symptoms depending on their location and size, such as pain, swelling, or organ dysfunction. The complexity of advanced solid tumors often requires a comprehensive approach to understand their behavior and impact on the body.