Study on the Safety and Effectiveness of GTAEXS617 for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called GTAEXS617 for patients with advanced solid tumors. Advanced solid tumors are a type of cancer that has spread and is not easily treated with surgery or radiation. The study aims to understand how safe the treatment is and how it behaves in the body, as well as its potential to fight cancer.

The study will be conducted in two main parts. In the first part, the treatment will be given alone to see how patients tolerate it and to determine the best dose. In the second part, the treatment will be combined with standard cancer treatments to see if it works better together. Throughout the study, researchers will monitor patients closely to ensure their safety and to gather information on how the treatment affects their cancer.

Participants in the study will take the treatment in the form of a tablet by mouth. The study will involve regular check-ups and tests to track the treatment’s effects and any side effects. The goal is to find out if GTAEXS617 can be a safe and effective option for treating advanced solid tumors.

1 joining the study

Upon joining the study, you will be asked to provide written consent, confirming your willingness to participate. This is a necessary step before any study-specific procedures begin.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your ability to swallow and retain oral medication, and ensuring you have adequate blood, liver, and kidney function.

3 treatment phase

You will begin taking the study medication, GTAEXS617, in the form of a tablet. This medication is taken orally. The dosage and frequency will be determined by the study team based on your specific needs and the study protocol.

The treatment phase is divided into different modules. In Module 1A, the focus is on understanding the safety of GTAEXS617 when used alone. In Module 1B, the medication is combined with standard care treatments to assess safety.

In Module 2A, the study evaluates the preliminary anti-tumor activity of GTAEXS617 alone, while Module 2B assesses its activity in combination with standard care.

4 monitoring and follow-up

Throughout the study, regular monitoring will occur to track your response to the medication and any side effects. This includes routine blood tests and other assessments as needed.

You will be asked to maintain a treatment diary to record your adherence to the medication schedule and any side effects you experience.

5 end of study

The study is expected to conclude by November 11, 2027. At the end of the study, a final assessment will be conducted to evaluate your overall health and the effects of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must be able and willing to provide written consent to participate in the study.
Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Must have an estimated life expectancy of more than 3 months.
Must be able to swallow and keep down oral medication.
Must have one of the following confirmed advanced solid tumors: head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), certain types of breast cancer, or ovarian cancer.
Must have a disease that is advanced, recurrent, or has spread to other parts of the body after standard treatments. If you have not received standard treatments, you may still be eligible if you cannot tolerate them or are not suitable for them.
Must have adequate blood, liver, and kidney function, as determined by specific medical tests.
If female, must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.
If male, must agree to use contraception if having female partners who can become pregnant and must not donate sperm during the study and for at least 6 months after the last dose.
Must have tumor lesions or metastases that can be biopsied, as confirmed by a radiologist, except for bone metastases.

Who Cannot Join the Study?

Patients with advanced solid tumors cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate. This means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Cvowagolj Uxduzlwhrygbre Sxyxqeoma	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	06.07.2023

Trial locations

Investigated drugs:

GTAEXS617 is a new medication being tested in this clinical trial. It is designed to help treat advanced solid tumors, which are a type of cancer. The trial is looking at how safe this medication is when used by itself and how well it works against tumors. Researchers are also studying how the body processes the medication and how patients respond to it. In some parts of the trial, GTAEXS617 is used alone, while in others, it is combined with standard treatments to see if it works better that way.

Investigated diseases:

Advanced solid tumors – Advanced solid tumors refer to a group of cancers that form solid masses in various organs or tissues and have progressed to a more severe stage. These tumors can originate in different parts of the body, such as the lungs, breast, prostate, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors can lead to increased symptoms, such as pain, swelling, or organ dysfunction, depending on their location. The growth and spread of these tumors can disrupt normal bodily functions and may require ongoing monitoring and management.

Trial ID:

2023-508227-13-00

Protocol code:

GTAEXS617-001

NCT ID:

NCT05985655

Trial Phase:

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

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Study on the Safety and Effectiveness of GTAEXS617 for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?