Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients with Selected Advanced Solid Tumors

This study is an early-stage clinical trial (Phase 1) looking into a new treatment called ADCT-901 for adults with advanced cancers that have grown or spread. This is the very first time this new medicine is being given to people. The main goals are to check how safe it is, find out what dose works best, and see if it causes any unwanted side effects. Researchers will also be checking how the body handles the medicine and whether it has any positive effects on the cancer. Since it's a new treatment, the study aims to gather important information to help decide if it can be studied further in larger groups of people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

ADC Therapeutics S.A.

Enrolment target

Start

18 Jul 2022

Advanced Solid Tumors

What is this study about?

Imagine your body as a complex machine. Sometimes, parts of that machine, like cells, start to grow out of control, leading to cancer. When these cancer cells spread to other parts of the body, it's called advanced cancer.

Doctors and scientists are always looking for new ways to treat cancer, and that's where studies like this one come in. This particular study is trying out a brand new medicine, ADCT-901. It's like testing a new tool for the very first time. The main aim is to understand how safe this new medicine is, what its effects are on the body (both good and bad), and to find the right amount (dose) to give. Researchers will also observe if it has any impact on the cancer itself.

Because this is a very early study (called 'Phase 1'), it focuses a lot on safety. The information gathered from people taking part will be really important. It will help doctors decide if ADCT-901 is promising enough to continue testing in more people in the future, ultimately hoping to find better treatments for advanced cancers.

Key takeaways

Tests a brand new cancer medicine, ADCT-901, for the first time in people.
Aims to check safety, side effects, and find the right dose for advanced solid tumours.
Open to adults aged 18 and over.
Involves regular hospital visits for medication, tests, and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adult men and women, aged 18 years and older, who have advanced solid tumours. This means cancers that started in a specific organ or tissue like the lung, breast, or bowel, and have spread within the body.

Typically, for studies like this, participants would have already tried standard cancer treatments, and those treatments might not have worked or may no longer be an option for them. You would also need to be well enough to take part in the study, meaning your overall health and organ functions (like your heart, liver, and kidneys) would need to be working reasonably well.

The research team will carry out several checks and tests to make sure that the study is safe for you to join and that you meet all the specific requirements. They will explain exactly what these are and answer any questions you have.

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 advanced cancer that has spread or grown?
Have you discussed this study with your cancer doctor?
Are you generally well enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, ADCT-901. As this is a dose-escalation study, the amount of medicine you receive might change over time, starting with a lower dose and possibly increasing under careful supervision. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health, how your body is handling the medicine, and to see how your cancer is responding. The exact number of visits and the total length of time you'd be involved would depend on how your body reacts to the medicine and your cancer progresses. The study team will explain the full schedule.

Potential risks and benefits

Potential benefits of joining this study include having access to a new experimental treatment that is not yet widely available and helping doctors learn more about cancer. However, there's no guarantee the treatment will help your specific cancer. Potential risks include experiencing side effects from the new medicine, which could be mild or severe, and some might not be known yet. The study team will closely monitor you for any side effects and manage them. Remember, taking part is completely voluntary. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'advanced solid tumours' mean?

It means cancers that started in an organ or tissue (like lung or breast) and have either grown extensively or spread to other parts of your body.

What does 'Phase 1 study' mean?

It's the first time a new medicine is being tested in humans. The main goal is to check its safety, find the right dose, and see what side effects it might cause.

Will this medicine cure my cancer?

It's too early to say. This study is mainly about safety and understanding the new medicine. It's not designed to find a cure, but to see if it shows promise for future development.

Do I have to pay to take part?

No, you should not have to pay for any study medications or visits related to the trial. Any travel costs might be reimbursed, but you should check this with the study team.

Can I continue with my usual cancer treatments?

No, if you join this study, ADCT-901 would be your primary treatment, and you would likely need to stop other anti-cancer treatments. The study team will explain all the specific rules.