Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination with Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants with Locally Advanced or Metastatic Solid Tumors

This research study is looking into a new medicine called ASP1570 for people with advanced solid tumours, which are cancers that have spread. We are testing ASP1570 by itself and also alongside existing treatments like pembrolizumab (Keytruda, a type of immunotherapy) or chemotherapy. The main goal is to check how safe ASP1570 is and if it causes any unwanted side effects when given alone or with other drugs. We will also be watching to see how effective it is at shrinking tumours or stopping them from growing. This study is for adults aged 18 and over, and it's an early-stage study, meaning it's one of the first times this drug is being tested in humans.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Astellas Pharma Global Development Inc.

Enrolment target

Start

17 Jun 2024

Advanced Solid Tumors

What is this study about?

This study is about a new medicine, ASP1570, which we hope could help treat advanced solid tumours. These are cancers that have grown or spread to other parts of the body. We're testing ASP1570 in different ways: sometimes on its own, and sometimes combined with treatments already used for cancer, such as chemotherapy or immunotherapy like pembrolizumab (you might know it as Keytruda). The idea is to find out if ASP1570 can be a safe and effective new option for patients.

The main thing we want to learn is about safety. We'll be carefully checking patients for any side effects, big or small, that might happen while taking ASP1570, both by itself and with other medicines. We'll look at things like blood tests, how your heart is doing, and your general well-being.

After we understand the safety, we'll also be looking at how well ASP1570 works. We'll measure if tumours shrink, stay the same size, or stop growing, to see if the treatment is helping. We'll also do special tests to understand how the drug moves through the body and if it has an impact on the immune cells around the tumour. This information is really important for developing new and better ways to fight cancer.

Key takeaways

This study is testing a new drug (ASP1570) for advanced solid tumours.
It aims to find out how safe the new drug is and if it helps shrink or control tumours.
The drug will be tested alone and with other standard cancer treatments.
It's an early-stage study, meaning it's one of the first times it's been given to people.
Participation involves regular check-ups and monitoring for side effects.

Who may be eligible?

This study is open to adults who are at least 18 years old. Both men and women can take part.

To be considered for this study, you must have advanced solid tumours. This means your cancer has either spread or grown in a way that makes it difficult to treat with standard methods.

There will be other, more detailed health requirements that your doctor will check to see if this study is suitable for you. These might include specific tests or past treatments you've had. It's important to discuss all your health conditions with the study team.

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 a diagnosis of advanced solid tumour?
Are you able to travel to study appointments?
Are you willing to potentially receive a new, experimental drug?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the study medication, ASP1570, possibly alongside other approved cancer treatments like chemotherapy or pembrolizumab. You would have regular visits to the clinic for check-ups, which would include blood tests, physical exams, and possibly scans to monitor your tumour. We would also keep a close eye on your vital signs, like your blood pressure and heart rate. You would be given instructions on how and when to take your medication, and you'd need to report any side effects you experience. The total duration of your participation would depend on how your treatment progresses and could vary from person to person. There would also be follow-up appointments after your treatment finishes to ensure your well-being.

Potential risks and benefits

Taking part in any clinical study carries both potential benefits and risks. You might benefit from a new treatment that isn't yet widely available, and your participation helps us learn more about treating cancer, which could help others in the future. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious. The study team will explain all known side effects. You have the right 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.

—
Unverified
Spain
—
Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers are solid tumours, like breast or lung cancer.

What does 'advanced' mean in this study?

In this study, 'advanced' means the cancer has spread from where it started to other parts of the body, or it has grown significantly despite previous treatments.

What is Keytruda (pembrolizumab)?

Keytruda is an existing cancer treatment called immunotherapy. It works by helping your body's own immune system find and fight cancer cells.

Will I know if I'm getting the new drug or an existing treatment?

The study design will be explained to you in detail. Sometimes, in studies like this, you might receive the new drug alone, or the new drug with an existing treatment. This will be made clear to you.

What is a 'Phase 1/2' study?

This means it's an early stage of human testing. Phase 1 focuses on safety and finding the right dose, while Phase 2 looks at how well the drug works and continues to monitor safety.