RecruitingPHASE1, PHASE2INTERVENTIONAL

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

This research is looking into a new treatment called ADCE-D01 for adults who have a type of cancer called soft tissue sarcoma. This is for people whose cancer has spread to other parts of their body (metastatic) or cannot be taken out with surgery (unresectable). The main goals of the study are to find out if ADCE-D01 is safe, if people can take it without too many side effects, and if it helps slow down or shrink the cancer. This new drug is an 'antibody-drug conjugate', which is designed to specifically target cancer cells. The study is currently in its early phases (Phase 1 and 2), which means it's one of the first times this drug is being tested in humans to understand its effects more fully.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Adcendo ApS

Enrolment target

270

Start

05 Jun 2025

Estimated completion

27 Feb 2029

Metastatic Soft Tissue Sarcoma Unresectable Soft Tissue Sarcoma

What is this study about?

This study is about a new potential treatment called ADCE-D01 for a type of cancer known as soft tissue sarcoma. Soft tissue sarcomas are cancers that can grow in muscles, fat, nerves, and other body tissues. This study is specifically for people whose sarcoma has spread to other parts of their body (which doctors call metastatic) or for people whose sarcoma cannot be completely removed surgically (unresectable).

The new drug, ADCE-D01, is a special type of medicine called an 'antibody-drug conjugate'. Think of it like a guided missile: the 'antibody' part is designed to find and attach to specific cancer cells, and the 'drug' part is a powerful medicine delivered directly to those cancer cells. This approach aims to attack cancer cells more precisely while reducing harm to healthy cells. This is an early-stage study (Phase 1/2), which means researchers are still learning a lot about this new drug.

The main things the researchers want to find out are whether ADCE-D01 is safe for people to take, how much of it people can tolerate without serious side effects, and if it shows any signs of shrinking the tumors or stopping them from growing. This information is key to deciding if the drug can move forward into larger studies and potentially become a new treatment option in the future.

Key takeaways

This study is testing a new drug, ADCE-D01, for specific types of soft tissue sarcoma.
It's for people whose cancer has spread or cannot be removed by surgery.
The main goals are to check the drug's safety, how well people tolerate it, and if it shrinks tumors.
The drug is designed to target cancer cells more precisely.
This is an early-stage study, meaning researchers are still learning about the drug's effects.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of soft tissue sarcoma that has spread or can't be removed by surgery. You should have already tried at least one, but no more than two, different chemotherapy-like treatments for your advanced cancer. It's important that your cancer can be measured to see if the treatment is working, and you should generally feel well enough to manage daily activities, with an expected lifespan of at least three months.

There are also some important rules about birth control. Men must agree to use barrier contraception (like condoms) during and for four months after the study treatment, and not donate sperm. Women must not be pregnant or breastfeeding. If you can become pregnant, you must agree to use reliable birth control during and for seven months after the study treatment.

However, you might not be able to join if you've recently had other cancer treatments (within the last four weeks), have cancer that has spread to your brain, or have serious heart conditions. Also, if you have certain infections like active Hepatitis B or HIV, or specific lung conditions such as a history of idiopathic pulmonary fibrosis, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have soft tissue sarcoma that has spread or can't be surgically removed?
Have you tried at least one, but no more than two, previous chemotherapy-like treatments for your advanced cancer?
Are you generally feeling well enough to do most daily activities?
Are you able to use reliable birth control if you are a man or a woman who can become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the investigational drug, ADCE-D01, which will be given as an infusion. The study will involve regular visits to the clinic where doctors will perform medical exams, blood tests, and scans (like CT scans) to check your health, see how you are tolerating the drug, and measure any changes in your cancer. You'll need to report any side effects you experience.

The total duration of your participation will depend on how you respond to the treatment and your health. Researchers will constantly monitor your condition throughout the treatment period and follow up with you regularly. We aren't given information in this brief about the exact number of visits or the specific follow-up schedule, but your study doctor will explain this in detail if you are considering joining.

Potential risks and benefits

Like all medical studies, there could be potential benefits and risks to taking part. A potential benefit is that the new drug, ADCE-D01, might help shrink your cancer or slow its growth, especially if other treatments haven't worked well. However, this is not guaranteed, as the drug is still being tested. There are potential risks, too, as new drugs can have side effects that aren't fully known yet. These could range from mild to serious, and the study team will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Colorado Denver
Verified postcode
Aurora, United States· Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
University Of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
Verified postcode
Leuven, Belgium· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Universitätsklinikum Essen West German Tumor Center
Verified postcode
Essen, Germany· Recruiting
Royal Marsden
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is 'soft tissue sarcoma'?

Soft tissue sarcoma is a type of cancer that can grow in soft tissues of the body, like muscles, fat, nerves, and blood vessels.

What does 'metastatic and/or unresectable' mean?

It means the cancer has spread to other parts of the body (metastatic) or cannot be fully removed by surgery (unresectable).

What is an 'antibody-drug conjugate'?

It's a special medicine that combines an antibody designed to find cancer cells with a powerful drug to kill them, like a targeted delivery system.

Why are there different 'phases' for studies?

Clinical trials happen in phases to make sure new treatments are carefully tested. Phase 1 focuses on safety, and Phase 2 looks at both safety and if the treatment works.

Will I definitely get the new drug?

Yes, if you meet all the requirements and decide to join this study, everyone will receive the new investigational drug, ADCE-D01.

How to find out more

René Smrčka

rene.smrcka@adcendo.com +45 3144 0653 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.