Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with Selected Advanced Solid Tumors

This is an early-stage research study, called a Phase 1b trial, looking into a new treatment named mipasetamab uzoptirine. It's for adults who have advanced solid tumours, which means their cancer has grown or spread. The main goals are to find out if the new medicine is safe, what side effects it might cause, and the best amount to give. Researchers will also check how the body handles the medicine and if it shows any signs of working against the cancer. They will test it on its own and sometimes combined with other cancer treatments to see if it works better together. This type of study is crucial for understanding new treatments before they can be used more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

ADC Therapeutics S.A.

Enrolment target

135

Start

28 Jul 2022

Advanced Solid Tumors

What is this study about?

This research study is focused on a new potential medicine called mipasetamab uzoptirine. It's an early-stage study, known as Phase 1b, which means it’s one of the first times this specific treatment is being tested in people. The main purpose of these early studies is to carefully check the safety of a new drug, figure out the right amount to give, and see how the body reacts to it. We need to do these steps before we can learn more about how well it treats illnesses.

Researchers are particularly interested in seeing if mipasetamab uzoptirine can help people with advanced solid tumours. 'Solid tumours' are cancers that form a lump, rather than being in the blood, and 'advanced' means the cancer has progressed or spread. They will be giving the medicine either by itself or sometimes with other anti-cancer treatments that are already known, to find out if combining them works better or is safer.

By taking part, patients are helping doctors learn more about this new medicine. This kind of research is vital because it helps us understand if new treatments could become options for cancer care in the future. The information gathered will guide future, larger studies.

Key takeaways

This is an early-stage study for a new cancer medicine.
It's for adults with advanced solid tumours.
The main goals are to check safety, side effects, and effective dose.
The medicine may be given alone or with other treatments.
Regular hospital visits and tests are part of taking part.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

You would need to have been diagnosed with advanced solid tumours. This means your cancer is one that forms a mass or lump, and it has either grown or spread to other parts of your body.

There will be other specific health checks and medical requirements that your doctor will discuss with you to make sure this study is right for your individual situation. Not everyone with advanced solid tumours will be able to take part.

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 solid tumours?
Are you willing to attend regular hospital visits and tests?
Have you discussed this trial with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, mipasetamab uzoptirine, and potentially other anti-cancer treatments, according to the study plan. You will have regular visits to the hospital or clinic for various tests and check-ups. These visits will involve blood tests, physical examinations, and scans to monitor your health, check for any side effects, and see how the treatment is affecting your cancer.

The total duration of your participation will depend on how you respond to the treatment and the study design. You will be closely monitored throughout the study, and there will likely be follow-up appointments even after you stop receiving the study medicine. All these steps are important to gather as much information as possible about the new medicine.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is receiving a new, investigational cancer treatment that might help your condition, even if it's not yet approved for general use. You would also receive close medical attention and monitoring. However, there are potential risks, including side effects from the study medicine, which might be new or not fully understood. It's important to know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Spain

Common questions

What does 'advanced solid tumours' mean?

It means you have a type of cancer that forms a lump rather than being in the blood, and that it has grown or spread.

What is a 'Phase 1b' study?

This is an early-stage human study. Its main purpose is to test the safety of a new medicine, see what side effects it might cause, and find the best amount to give.

What is mipasetamab uzoptirine?

It's the name of the new medicine being tested in this study for people with advanced solid tumours. It's still under investigation.

Will this medicine cure my cancer?

This is an early study to see if the medicine is safe and shows any signs of helping. It's too early to know if it can cure cancer, and a cure is not guaranteed.

Do I have to pay to be in the study?

No, typically participation in clinical trials does not require you to pay. All study-related treatments and assessments are usually covered by the study sponsor.