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Study of BT5528 alone and with nivolumab in patients with advanced solid tumors that have EphA2 protein expression

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What is this trial about?

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

This study focuses on patients with advanced malignancies associated with EphA2 expression. The study will test a new medication called BT5528, both alone and in combination with another drug called nivolumab. The types of cancer being studied include urothelial cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, triple negative breast cancer, and gastric cancer.

The purpose of this research is to evaluate how safe BT5528 is and how well patients tolerate it, both when used alone and when combined with nivolumab. The study will also look at how effective these treatments are in fighting different types of cancer. Both medications will be given through intravenous infusion.

During the study, participants will receive either BT5528 alone or in combination with nivolumab. The study consists of two main parts. The first part focuses on finding the right dose and checking safety. The second part looks at how well the treatment works in specific types of cancer. Throughout the study, doctors will monitor participants' health and how their cancer responds to the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medical assessment
Your eligibility for the trial will be confirmed through medical tests checking your organ function and blood count.
A tissue sample from your tumor will be analyzed to check for EphA2 expression. If no previous sample is available, a new biopsy will be needed.
For women who can become pregnant, a pregnancy test will be required before starting treatment.
Step 2
Treatment assignment
You will be assigned to one of two treatment groups:
Group 1 (Part A-1): Treatment with BT5528 alone
Group 2 (Part A-2): Treatment with BT5528 combined with nivolumab
Both medications will be given through intravenous infusion (directly into your vein)
Step 3
Treatment period
Regular monitoring of your health status will occur throughout the treatment period
Your tumor response will be measured using imaging scans
Blood samples will be taken to measure drug levels in your body
Side effects will be monitored and recorded using standardized criteria
Step 4
Follow-up period
After completing treatment, you will need to use effective birth control for 6 months following the last dose of BT5528
If you received nivolumab, birth control should continue for 5 months after the last dose
Your health status will continue to be monitored to assess the long-term effects of the treatment

Who can join the trial?

11 criteria

You must provide written consent before participating in the study
You must be at least 18 years old
You must have good physical functioning ability (ECOG score of 0 or 1), meaning you can perform daily activities with minimal assistance
Your disease must be measurable using standard imaging techniques
You must have adequate kidney function and liver function as shown by blood tests
You must have adequate blood cell counts, including: - Sufficient red blood cells (hemoglobin level) - Sufficient white blood cells (neutrophil count) - Sufficient platelets
If you are a woman who can become pregnant, you must have a negative pregnancy test
Both men and women must use effective birth control during the study and for 6 months after the last dose of treatment
You must have or be willing to provide a tumor tissue sample for testing
Your expected survival must be at least 12 weeks from the start of treatment
You must be willing to follow all study procedures and requirements

Who cannot join the trial?

15 criteria

Age under 18 years old
History of untreated brain metastases (cancer that has spread to the brain)
Known active hepatitis B or C infection (liver infections)
Active or uncontrolled infections requiring treatment
Previous treatment with any EphA2-targeting therapy (specific type of cancer treatment)
Major surgery within 4 weeks before starting the study
Peripheral neuropathy (nerve damage causing numbness or weakness) grade 2 or higher
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Significant heart conditions, including:
- Heart failure
- Heart attack within past 6 months
- Unstable heart rhythm
- Pregnant or breastfeeding women
- Current participation in other clinical trials
- Known allergic reactions to study medications
- Immunodeficiency (weakened immune system) or active autoimmune disease requiring treatment
- Serious medical conditions that could interfere with study participation

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Verified sites

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

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

BT5528
is an investigational medication being studied for treating various types of advanced cancers that express a specific protein called EphA2. This medication is designed to specifically target cancer cells that have high levels of EphA2 protein on their surface.
Nivolumab
is a medication that helps the body's immune system fight cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, it is being studied in combination with BT5528 to see if the two medications work better together.
Monomethyl auristatin E (MMAE)
is a powerful anti-cancer compound that is used in certain cancer treatments. In this trial, researchers are specifically looking at patients with urothelial cancer who have previously received MMAE-based therapy.

What is already known about the treatment

BT5528
An investigational therapeutic agent being studied in clinical trials for advanced malignancies associated with EphA2 expression. It is administered intravenously and is being evaluated both as a monotherapy and in combination with nivolumab. The drug targets tumors that express EphA2, including urothelial cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, triple negative breast cancer, and gastric/upper GI cancers. BT5528 is currently in Phase I/II clinical trials to determine its safety, tolerability, and preliminary clinical activity, while also establishing the maximum tolerated dose and recommended Phase II dosing.
Nivolumab
A well-established immunotherapy medication administered intravenously that belongs to the class of PD-1 inhibitors. It works by blocking the PD-1 protein on immune cells, helping the body's immune system recognize and attack cancer cells more effectively. In this clinical trial, nivolumab is being studied in combination with BT5528 to potentially enhance the therapeutic effect against EphA2-expressing tumors.

Investigated diseases

Urothelial Cancer
A cancer that begins in the urothelial cells, which line the urinary system. It most commonly starts in the bladder but can occur anywhere in the urinary system. The cancer develops when urothelial cells begin to grow uncontrollably and form tumors.
Ovarian Cancer
A type of cancer that develops in the ovaries, the female reproductive organs that produce eggs. It occurs when abnormal cells in the ovary begin to multiply and form a mass of cells.
Non-Small Cell Lung Cancer
A type of lung cancer that forms in the tissues of the lung. It typically grows and spreads more slowly than small cell lung cancer and is the most common type of lung cancer.
Head and Neck Cancer
Cancer that starts in the tissues or organs of the head and neck area. This includes cancers of the mouth, throat, voice box, nose, and sinuses.
Triple Negative Breast Cancer
An aggressive type of breast cancer that lacks three common types of receptors that fuel most breast cancer growth. The cancer cells test negative for estrogen receptors, progesterone receptors, and excess HER2 protein.
Gastric Cancer
A cancer that forms in the lining of the stomach. It develops when cells in the stomach begin to grow out of control and eventually form a tumor.