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

A Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors

This medical study is looking at a new drug called ABBV-155. Researchers want to see how safe it is and what side effects it might cause when given alone and when given with a common type of chemotherapy called taxane therapy. It’s for adult patients whose solid tumours, such as some types of lung cancer or breast cancer, have either returned after treatment or haven't gotten better with standard care. This is a very early stage study, meaning it's the first time this drug is being tested in people to understand how it works.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
AbbVie Deutschland GmbH & Co. KG
Enrolment target
1
Start
18 Jul 2024

What is this study about?

This study, called "A Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors," is an important step in developing new treatments for several types of cancer. When cancer is described as 'relapsed,' it means it has come back after treatment. 'Refractory' means it hasn't responded to previous treatments.

The main goal of this research is to see how safe a new medicine called ABBV-155 is in people. Researchers will also be looking at what effects it has on the body. They want to understand how it works when given on its own and when combined with a well-known group of cancer drugs called taxanes, which are a type of chemotherapy.

This is a 'Phase I' study, which means it's one of the very first times this experimental drug is being given to humans. These early studies are crucial for gathering basic information on safety and how the drug behaves in the body before it can be tested in larger groups of people. Conditions being looked at include small cell lung cancer, non-small cell lung cancer, and breast cancer.

Key takeaways

  • This study is testing a new cancer drug called ABBV-155.
  • It's for adults with certain types of lung or breast cancer that have returned or not responded to other treatments.
  • The drug is being tested alone and with other chemotherapy.
  • It's an early-stage study, focused on safety and understanding the drug.
  • Participation involves regular clinic visits for monitoring.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Critically, you must have been diagnosed with a specific type of solid tumour. This means your cancer is not a blood cancer, but one that forms a lump or growth. Your cancer also needs to have either returned after you've had treatment for it (this is called 'relapsed') or it hasn't responded well to the treatments you've already received (this is called 'refractory'). This includes certain types of lung cancer (small cell or non-small cell) and breast cancer.

There will be other detailed health requirements that your doctor will need to check to make sure the study is safe and right for you. These will be discussed fully if you express interest.

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.

  1. Are you 18 years old or older?
  2. Do you have a solid tumour diagnosis (not a blood cancer)?
  3. Has your cancer come back after treatment, or not responded to previous treatments?
  4. Has your doctor diagnosed you with small cell lung cancer, non-small cell lung cancer, or breast cancer?
  5. Are you able to attend appointments regularly at the study clinic?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational drug, ABBV-155. Depending on the part of the study, this might be given alone or with a taxane chemotherapy drug. You would have regular appointments at the study clinic. During these visits, the study team would monitor your health carefully, which would involve physical exams, blood tests, and imaging scans (like X-rays or CT scans) to see how you're responding to the treatment and to check for any side effects. The total length of your participation would depend on how you respond to the treatment and the study plan, but you would be fully informed about the expected duration during the consent process. There would also be follow-up appointments after you stop taking the study drug to monitor your health.

Potential risks and benefits

Participating in a clinical trial like this could offer a chance to try a new treatment that isn't widely available yet, which might help your condition. However, because this is an early-stage study, the full benefits are not yet known, and there's no guarantee that the treatment will help you personally. Like all medicines, ABBV-155, especially when combined with other drugs, can cause side effects, some of which might be serious or unexpected. The study team will explain all known potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

Common questions

What is ABBV-155?

ABBV-155 is a new experimental drug that researchers are testing to see if it can treat certain types of cancer.

What does 'relapsed or refractory' mean?

It means your cancer has either come back after previous treatment, or it hasn't responded to the treatments you've had so far.

Is this a new treatment for all cancers?

No, this study is specifically looking at certain solid tumours, like particular types of lung and breast cancer that are relapsed or refractory.

What phase is this study?

This is a Phase I study, which means it's one of the first times this drug is being tested in humans to check its safety.

Do I have to pay to be in the study?

No, usually all study-related treatments and tests are provided at no cost to you.

How to find out more

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

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