Study of MDNA11 Alone or with Pembrolizumab for Patients with Advanced Solid Tumors

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hrfxqpoo Uhnqzwhfwasmi Mivvpsf Dg Vhuplgsqcp	Santander	Spain
Ibnasdze Cthqwf Dkhhjjkbqbvqtifnk	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Ireland	Recruiting	01.05.2024
Poland	Not recruiting	01.05.2024
Portugal	Recruiting	01.05.2024
Spain	Recruiting	01.05.2024

Trial locations

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.

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.

Trial ID:

2023-507536-21-00

Protocol code:

MDNA11-01

NCT ID:

NCT05086692

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of MDNA11 Alone or with Pembrolizumab for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?