Study of ADCE-D01 for Patients with Metastatic or Unresectable Soft Tissue Sarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer known as Soft Tissue Sarcoma, which can spread to other parts of the body or cannot be removed through surgery. The treatment being tested is a new medication called ADCE-D01. This medication is a special type of drug known as a humanized antibody, which is designed to target and attack cancer cells. It is linked to a substance that helps stop cancer cells from growing and dividing.

The purpose of this study is to evaluate the safety and effectiveness of ADCE-D01 in treating patients with Soft Tissue Sarcoma. The study will be conducted in two main phases. In the first phase, different doses of the medication will be tested to find the most suitable dose that patients can tolerate. In the second phase, the study will focus on how well the medication works in controlling the cancer. Throughout the study, participants will receive the medication through an intravenous infusion, which means it will be given directly into a vein.

Participants in the study will be closely monitored to see how their bodies respond to the treatment and to check for any side effects. The study aims to gather important information about the medication’s ability to reduce the size of tumors and improve the overall health of patients with Soft Tissue Sarcoma. This research is an important step in finding new and effective treatments for this type of cancer.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history, current health status, and any previous treatments you have received for soft tissue sarcoma.

You will undergo various tests, such as blood tests and imaging scans, to establish a baseline for your health and the extent of your condition.

3 treatment phase 1a

In Phase 1a, you will receive the study medication, ADCE-D01, through an intravenous infusion. The dosage will be gradually increased to determine the maximum tolerated dose.

You will be closely monitored for any side effects or adverse reactions. Regular blood tests and health assessments will be conducted to ensure your safety.

4 treatment phase 1b

In Phase 1b, the dosage of ADCE-D01 will be confirmed based on the results from Phase 1a. You will continue to receive the medication through intravenous infusion.

Your response to the treatment will be evaluated, and any side effects will be monitored. Adjustments to the dosage may be made if necessary.

5 treatment phase 2

In Phase 2, the focus will be on evaluating the antitumor activity of ADCE-D01. You will receive the medication at the confirmed dosage from Phase 1b.

Regular assessments will be conducted to monitor the effectiveness of the treatment and any side effects. Your overall health and response to the medication will be closely observed.

6 follow-up

After completing the treatment phases, you will enter a follow-up period. During this time, your health will be monitored to assess the long-term effects of the treatment.

You will have scheduled visits for health assessments and tests to ensure your well-being and to gather data on the treatment’s impact.

Who Can Join the Study?

Must be at least 18 years old.
Must have a life expectancy of at least 3 months.
Any side effects from previous treatments must be mild or have returned to the level they were before treatment. Some ongoing mild side effects like hair loss, nerve issues, or hormone problems managed with medication are allowed.
Men must agree to use a condom during treatment and for at least 4 months after the last treatment. If their partner is pregnant, they must avoid sexual activity or use a condom to protect the baby.
Women must not be pregnant or breastfeeding. They must either be unable to have children or agree to use birth control during treatment and for at least 7 months after the last treatment.
Must be willing and able to attend scheduled visits, follow the treatment plan, and complete necessary tests and procedures.
Must be able to provide informed consent, which means understanding and agreeing to the study’s requirements and restrictions.
Must have a confirmed diagnosis of Soft Tissue Sarcoma (STS) that is either spread to other parts of the body or cannot be removed by surgery.
Must have received at least one but no more than two types of chemotherapy for the disease that has spread or cannot be removed. One of these treatments must have included a drug called an anthracycline, unless it was not suitable for them. They may have had other non-chemotherapy treatments.
The disease must be getting worse, as determined by the doctor.
Must have at least one tumor that can be measured by the study’s criteria.
Must provide a sample of the tumor for testing, either from a previous sample taken within the last 12 months or a new sample if safe to do so.
Must have certain blood and organ function levels within specified ranges, including:
- Hemoglobin (a protein in red blood cells) of at least 9.0 g/dL.
- White blood cell count (ANC) of at least 1.5 x 10⁹/L.
- Platelet count of at least 100 x 10⁹/L.
- Total bilirubin (a liver function test) of no more than 1.5 times the upper limit of normal, or 3 times if they have Gilbert syndrome.
- Liver enzymes (ALT and AST) no more than 2.5 times the upper limit of normal, or 5 times if due to liver metastases.
- Kidney function (eGFR) of at least 60 mL/min.
- Blood clotting (PT or INR) within normal limits unless on blood thinners, in which case it must be within the therapeutic range.
- Potassium and calcium levels within normal limits.
Must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.

Who Cannot Join the Study?

Patients with any other type of cancer besides Soft Tissue Sarcoma cannot participate.
Patients who have not fully recovered from previous cancer treatments are excluded.
Patients with severe heart problems are not eligible.
Patients with uncontrolled infections cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients who are unable to follow the study procedures for any reason cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Cmslli Lpvw Bglqsx	Lyon	France
Ueioocxmzudtpqaslsars Emvvi Arj	Essen	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.05.2025
France	Recruiting	01.05.2025
Germany	Recruiting	01.05.2025

Trial locations

Investigated drugs:

ADCE-D01

ADCE-D01 is a new type of treatment being tested in this clinical trial. It is a specially designed antibody that targets a specific protein found on certain cancer cells. This antibody is linked to a drug that can help stop cancer cells from growing and dividing. The goal of this treatment is to see if it can help shrink tumors in patients with a type of cancer called soft tissue sarcoma, which is either spread to other parts of the body or cannot be removed with surgery. The study is looking at how safe this treatment is, how it behaves in the body, and whether it can effectively fight the cancer.

Soft Tissue Sarcoma – Soft tissue sarcoma is a type of cancer that begins in the tissues that connect, support, and surround other body structures. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can occur in any part of the body but is most common in the arms, legs, and trunk. As it progresses, the tumor may grow and invade nearby tissues, potentially spreading to other parts of the body. The growth rate and pattern can vary significantly depending on the specific type of sarcoma. Symptoms often include a noticeable lump or swelling, which may or may not be painful.

Trial ID:

2024-516900-41-00

Protocol code:

ADCE-D01-001

Trial Phase:

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

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Study of ADCE-D01 for Patients with Metastatic or Unresectable Soft Tissue Sarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?