Active not recruitingPHASE1, PHASE2INTERVENTIONAL

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

This study is investigating a new medication called visugromab (CTL-002) for people living with advanced cancer. It's a 'first-in-human' study, meaning it's one of the first times this drug is being tested in people. The main goals are to understand how safe visugromab is, to find the right dose, and to see how well it works, both on its own and when combined with another common cancer treatment called a checkpoint inhibitor. The study has two main parts. The first part, which has now finished, looked at different doses. The second part, which is ongoing, is testing visugromab with a checkpoint inhibitor in specific types of solid tumours. This research is important for finding new ways to treat cancer and improve the lives of patients.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

CatalYm GmbH

Enrolment target

263

Start

09 Dec 2020

Estimated completion

30 Apr 2030

Solid Tumor, Adult

What is this study about?

This research is a 'first-in-human' study, meaning it's one of the first times this new drug, called visugromab (or CTL-002), is being tested in people. The main purpose is to see if it's safe, find the best amount (dose) to give, and understand how it works against different types of advanced solid cancers. Solid cancers are those that form a lump or mass, like breast cancer, lung cancer, or bowel cancer.

Visugromab works by targeting a specific protein in the body. The study also looks at using visugromab together with another type of cancer treatment called a 'checkpoint inhibitor.' These inhibitors are already approved and help the body's own immune system fight cancer more effectively. By combining these treatments, researchers hope to improve the chances of fighting the cancer.

The study is divided into two main phases. The first part, which has now finished, involved a smaller group of patients and focused on finding safe doses of visugromab. The second part is now looking at how well visugromab, when given with a checkpoint inhibitor, works in larger groups of patients with seven different types of solid tumours. This means the study is carefully exploring its potential benefits for a range of cancers.

Key takeaways

This study is testing a new drug for advanced solid cancers.
The drug, visugromab, is given by drip and can be combined with an existing cancer treatment.
It's a 'first-in-human' study, meaning it's early research for this drug.
The study aims to find safe doses and see how well it works.
Participation involves regular visits, tests, and potentially biopsies.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with an advanced or recurring solid cancer. Your cancer should have continued to grow or come back even after you've had at least one treatment that works on your immune system (like a PD-1/PD-L1 inhibitor).

You'll also need to be well enough to take part, meaning you can look after yourself and have healthy major organs like your heart, liver, and kidneys. There are also specific requirements about your tumour, such as it being able to be biopsied and measured. You should expect to live for more than three months, as judged by your doctor.

However, there are reasons you might not be able to join. For example, if you are pregnant or breastfeeding, or have had certain other medical conditions recently, such as serious heart problems, active autoimmune diseases needing strong medication, or active stomach conditions like Crohn's disease. You also can't have had other cancer treatments or experimental drugs too close to the start of the study.

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 an advanced or recurring solid cancer?
Has your cancer progressed even after at least one previous immune-based treatment?
Are you generally well enough to manage everyday activities?
Do your doctors believe your major organs (heart, liver, kidneys) are working well?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study drug, visugromab (CTL-002), through a drip into your vein. The study aims to find the most effective and safest dose. You'll likely also receive an approved checkpoint inhibitor alongside visugromab.

Throughout the study, you'll have regular hospital visits for assessments. These will include blood tests, scans to check your cancer, and check-ups with the study doctors and nurses. Some parts of the study also require small tissue samples (biopsies) from your tumour. The exact number of visits and the total length of time you'll be involved will depend on the study's specific plan and how your treatment progresses, but it will involve ongoing monitoring and follow-up.

Potential risks and benefits

Taking part in a clinical trial like this could potentially offer access to a new treatment before it's widely available, which might help to slow or stop your cancer's growth. However, there are also potential risks; visugromab is a new drug, and not all side effects are fully known. You might experience side effects from the drug itself or from the combination with the checkpoint inhibitor. Your doctors will carefully monitor you for any problems. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik und Poliklinik
Verified postcode
Essen, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik I
Verified postcode
Frankfurt am Main, Germany
Universitätsklinikum Würzburg, Comprehensive Cancer Center
Verified postcode
Würzburg, Germany
Next Oncology, Phase I Unit. IOB - Hospital Quironsalud
Verified postcode
Barcelona, Spain
Hospital Universitari Vall d'Hebron, Institute of Oncology
Verified postcode
Barcelona, Spain
ICMDiM, Hospital Clinic
Verified postcode
Barcelona, Spain
ICO Hospitalet, Hospital Duran i Reynals
Verified postcode
Barcelona, Spain
Hospital Universitario 12 de Octubre
Verified postcode
Madrid, Spain
START Madrid, Hospital Universitario HM Sanchinarro
Verified postcode
Madrid, Spain
Clinica Universidad de Navarra, Unidad Central de Ensayos Clinicos
Verified postcode
Pamplona, Spain
University Hospital Basel, Department for Medical Oncology
Verified postcode
Basel, Switzerland
Kantonsspital St. Gallen, Clinic for Medical Oncology & Hematology
Verified postcode
Sankt Gallen, Switzerland

Common questions

What is 'advanced solid tumour'?

An advanced solid tumour is a cancer that has grown and may have spread to other parts of the body, and it forms a lump or mass, rather than being a blood cancer.

What is visugromab (CTL-002)?

Visugromab is a new drug being tested in this study. It's a type of medicine called a 'monoclonal antibody' that works by targeting a specific protein in the body to help fight cancer.

What is a 'checkpoint inhibitor'?

Checkpoint inhibitors are existing cancer drugs that help your body's immune system recognise and attack cancer cells more effectively.

What does 'first-in-human' mean?

It means this is one of the very first times this new drug is being given to people, so researchers are learning a lot about its effects.

Will I get better if I join this study?

There's no guarantee that you will get better. Clinical trials aim to find out if new treatments work. Your doctors will monitor you closely to see if the treatment is helping.