RecruitingPHASE1INTERVENTIONAL

Study of STP938 in Advanced Solid Tumours

This research study is looking at a new medicine called STP938 for people who have advanced solid tumours. These are cancers that started in solid organs and have spread or are difficult to treat with current therapies. The study is divided into two main parts. The first part will carefully increase the dose of STP938 to find the safest and most effective amount. The second part will then check the safety of this chosen dose in more detail, still giving only STP938. The main goal is to understand how well the drug is tolerated and if it shows any promise in treating these types of cancers. Participants would receive STP938 alone, without other cancer treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Step Pharma, SAS

Enrolment target

Start

02 Aug 2024

Estimated completion

01 May 2027

Solid Tumor

What is this study about?

This clinical trial is designed to investigate a new drug called STP938 for patients living with advanced solid tumours. Advanced solid tumours are cancers that have grown or spread, and current treatments aren't working as well as hoped, or there aren't many other options left. The scientists want to see if STP938 could be a new way to help people with these cancers.

The study has two main steps. The first step, called Phase 1a, will involve a small group of patients who will receive different, gradually increasing doses of STP938. This is to carefully find the dose that is both safe and has the best chance of working. It's like finding a balance point where the medicine is strong enough to have an effect but not too strong to cause many side effects.

Once the safest dose is found, the study moves to Phase 1b. In this step, a larger group of patients will receive that specific dose of STP938. The main focus here is to gather more information about the drug's safety when used on its own, and to confirm that it's well-tolerated. This phased approach is a common and careful way to test new medicines, ensuring patient safety is always a top priority.

Key takeaways

This study is for people with advanced solid tumours who have limited treatment options.
It's testing a new drug called STP938 to find a safe dose and check for side effects.
STP938 will be given alone, without other cancer treatments.
Regular health checks and scans will monitor your progress and safety.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have an advanced solid tumour that isn't expected to be cured by other treatments and needs ongoing medical care. Your doctors would need to feel you still have a life expectancy of more than three months, and your body organs (like your liver, kidneys, and bone marrow) should be working well enough.

The study also requires that most side effects from any previous cancer treatments have either gone away completely or are very mild. This helps ensure that any new side effects can be clearly linked to the study drug. You'll also need to have some tumour tissue available for special tests.

However, some conditions would mean you can't join. For example, if you are pregnant or breastfeeding, or if you have certain active brain cancers or infections. Also, if you've had other cancer treatments or radiation very recently, or certain heart conditions, you might not be able to participate. The study team will review all your medical information carefully to see if this study is right and safe for you.

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 or older?
Do you have an advanced solid tumour that needs new treatment options?
Have serious side effects from your previous treatments mostly gone away?
Are your major organs (like kidneys and liver) working well?
Are you not pregnant or breastfeeding, and willing to use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, STP938, as a single treatment. The study team will schedule regular visits to the clinic to monitor your health closely. These visits will involve various assessments, including blood tests, physical examinations, and scans to see how your body is responding to the drug and if your tumour is changing. You'll also be asked about any side effects or changes you notice.

The exact number and timing of visits, as well as the total length of your participation, will depend on which part of the study you are in and how you respond to the treatment. The researchers will explain the full schedule to you before you agree to join. They will continue to follow your health for a period even after you stop taking the study drug.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment like STP938 before it's widely available. It also contributes to medical knowledge, which could help future patients. However, there are also potential risks, as STP938 is an investigational drug and its full side effects are not yet known. You might experience side effects that range from mild to serious. The study team will monitor you closely and explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

Comprehensive Hematology Oncology, LLC
Verified postcode
St. Petersburg, United States· Recruiting
Mary Crowley Cancer Research Center
Verified postcode
Dallas, United States· Recruiting
Next Oncology
Verified postcode
San Antonio, United States· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
The Beatson Institute for Cancer Research
Verified postcode
Glasgow, United Kingdom· Recruiting
University College London
Verified postcode
London, United Kingdom· Recruiting
The Christie
Verified postcode
Manchester, United Kingdom· Recruiting

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, for example, breast cancer, lung cancer, or colon cancer.

What does 'Phase 1' mean in a study?

Phase 1 is the first stage of testing a new drug in humans. It focuses on finding a safe dose and understanding how the drug behaves in the body, rather than how well it treats the disease.

Will I receive other cancer treatments during the study?

No, this study is testing STP938 on its own, so you would not receive other cancer treatments while taking part in this specific trial.

What are 'biomarkers'?

Biomarkers are unique biological signs in your body, like certain genes or proteins. Scientists can test for these in your tumour tissue to see how the cancer might respond to treatment.

Can I leave the study at any time?

Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any point without it affecting your ongoing medical care.

How to find out more

Maureen Higgins

STP938-201@step-ph.com +33 1 86 26 43 56 Official trial record

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