RecruitingPHASE1, PHASE2INTERVENTIONAL

A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

This study is for adults diagnosed with certain types of lymphoma, a cancer affecting blood cells, that has returned or not responded to previous treatments. It's testing a new medicine called STP938. The study has two main parts. The first part focuses on finding the safest dose for STP938. The second part will then use this dose to see how effective the medicine is in treating five different types of B-cell and T-cell lymphomas. Researchers believe STP938 might work by blocking a specific enzyme important for the growth of some cancer cells. The goal is to see if this new approach can help people with these challenging forms of lymphoma.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Step Pharma, SAS

Enrolment target

180

Start

03 Aug 2022

Estimated completion

01 Dec 2026

Lymphoma, B-Cell Lymphoma, T-Cell

What is this study about?

This study is looking into a new medicine called STP938 for adults who have different types of lymphoma. Lymphoma is a cancer that starts in infection-fighting cells in the blood called lymphocytes. This study is specifically for people whose lymphoma has come back after treatment or hasn't responded to previous treatments.

The medicine, STP938, works by blocking a specific tiny helper (an enzyme) inside cells. This helper, called CTPS1, is important for making part of the building blocks that cells need to grow and divide. Scientists have found that some cancer cells, like those in certain lymphomas, rely heavily on this particular helper to grow quickly. By blocking CTPS1, STP938 aims to stop these cancer cells from growing, while other healthy cells in the body, which use a different helper, are largely unaffected.

The study has two main stages. The first stage will carefully test different amounts of STP938 to find a dose that is safe and well-tolerated by patients. Once this best dose is found, the second stage will give this dose to more patients with five different kinds of B-cell and T-cell lymphomas. The main purpose here is to see how well STP938 works in treating these specific types of lymphoma.

Key takeaways

This study is for adults with specific types of lymphoma that have returned or not responded to previous treatments.
It tests a new medicine called STP938, given as a tablet.
The study aims to find a safe dose and see how well STP938 works in different B-cell and T-cell lymphomas.
Participation involves taking the medicine, blood tests, and regular clinic visits.
You can stop participating in the study at any time.
There's a potential benefit from a new treatment, but also possible side effects.

Who may be eligible?

This study is for adults aged 18 or over who have been diagnosed with certain types of B-cell or T-cell lymphoma. You would be considered for this study if your lymphoma has returned or hasn't responded to at least two previous treatments, and there are no other standard treatments known to help you right now.

To join, doctors need to be able to measure your cancer to see if the treatment is working. You also need to be generally well enough to take part and have good organ function (like your blood, liver, and kidneys). Any side effects from your previous cancer treatments should have mostly cleared up.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if your lymphoma has spread to your brain or spinal cord. You also can't have had other cancers recently, or certain serious ongoing health problems. You will need to discuss all your medical history 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 B-cell or T-cell lymphoma?
Has your lymphoma come back or not responded to at least two previous treatments?
Are you generally feeling well enough to take part?
Are you able to take medicine as a tablet?
Do you currently have cancer that can be measured by doctors (unless it's a specific skin lymphoma called CTCL)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the medicine STP938 as a tablet. The study team will take regular blood samples to see how your body is reacting to the medicine and how it affects your lymphoma. You will have regular visits to the clinic for medical checks and to discuss how you are feeling. Throughout the study, the doctors and nurses will monitor your health closely.

The first part of the study focuses on finding the right dose, which might involve slowly increasing the amount of STP938 you take. The second part will then observe how well this dose works. The total duration of your participation will depend on how you respond to the treatment and the study plan, which will be fully explained to you before you decide to join.

Potential risks and benefits

Taking part in this study means you might be among the first to try a new medicine that could potentially help treat your lymphoma if other treatments haven't worked. However, like all medicines, STP938 may cause side effects, some of which could be serious. The research team will carefully monitor you for any side effects and will explain all known and potential risks. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

Colorado Blood Cancer Institute
Verified postcode
Denver, United States· Recruiting
Florida Cancer Specialists
Verified postcode
Sarasota, United States· Recruiting
Memorial Sloan Kettering
Verified postcode
New York, United States· Recruiting
Hôpital Saint-Louis
Verified postcode
Paris, France· Recruiting
The Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
CHU de Nantes
Verified postcode
Nantes, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting
Imperial College / Clinical Trials Unit, Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting
The Christie
Verified postcode
Manchester, United Kingdom· Recruiting
Nottingham City Hospital
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is lymphoma?

Lymphoma is a type of cancer that starts in infection-fighting white blood cells called lymphocytes.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after treatment (relapsed) or hasn't responded well to previous treatments (refractory).

How is STP938 given?

STP938 is given as a tablet that you take by mouth.

Will I know if the medicine is helping?

The study team will regularly check how your lymphoma is responding to the treatment using scans and other tests, and they will share this information with you.

Can I stop taking part in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Maureen Higgins

stp938-101@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.