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

A Phase 1/2a, Open-label, Dose Escalation Trial of GEN3017 with Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma

This early-stage study, called GEN3017, is open for people aged 18 and over who have Hodgkin lymphoma or a type of non-Hodgkin lymphoma. The main goal is to find a safe and effective dose of a new medicine, also called GEN3017. Researchers will carefully watch for any side effects and how the body handles the medicine. They also want to see if the new medicine helps shrink the cancer. This trial includes two main parts: first, a dose-finding stage where doctors look closely for any serious side effects, and then an expansion stage where more people will take the treatment to further understand its benefits and safety. Other medicines like Prednisolone and Paracetamol might be given to help manage potential side effects.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Genmab A/S

Enrolment target

109

Start

13 Nov 2023

Hodgkin lymphoma or non-Hodgkin lymphoma

What is this study about?

This trial is looking into a new treatment called GEN3017 for people who have Hodgkin lymphoma or a specific type of non-Hodgkin lymphoma. These are both types of cancer that affect the body's immune system. The treatment is in its early stages of testing, which means this is one of the first times it's being given to humans. Early-stage trials are very important for understanding if a new medicine is safe and if it could be helpful for patients.

The study has two main parts. The first part, called 'Dose Escalation', is about finding the right amount of the new medicine to give. Doctors will start with a small dose and gradually increase it in different groups of patients, watching very carefully for any side effects or problems. Their main focus here is safety – figuring out what dose is tolerated well. The second part, called 'Expansion', will involve more patients receiving the treatment once a safe dose has been found. In this part, researchers will continue to monitor safety but will also be looking more closely at how well the medicine works to shrink the cancer and if it helps patients feel better.

Researchers will use different ways to measure if the treatment is working, such as checking if the cancer shrinks or disappears. They will also look at how long the treatment keeps the cancer under control and how long people live after starting the treatment. The goal of this study is to gather important information about this new medicine to see if it could become a new option for treating these types of lymphoma in the future.

Key takeaways

This is an early-stage study for a new lymphoma treatment.
It's for people with Hodgkin or non-Hodgkin lymphoma that has returned or not responded to past treatments.
The study aims to find a safe dose and see if the new medicine, GEN3017, can shrink the cancer.
Participation involves regular clinic visits for treatment and monitoring.
You will be closely watched for any side effects throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. People of all genders can take part. You must have been diagnosed with either Hodgkin lymphoma or a specific type of non-Hodgkin lymphoma.

Your lymphoma must be what doctors call 'relapsed or refractory.' This means your cancer has either come back after previous treatments or it hasn't responded well to other treatments you've tried.

There will be other detailed health checks to make sure the study is a good fit for you and that you can safely receive the study medicine. This includes certain blood test results and other medical conditions.

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?
Have you been diagnosed with Hodgkin lymphoma or a specific type of non-Hodgkin lymphoma?
Has your lymphoma come back or not responded well to previous treatments?
Are you able to attend regular clinic appointments and follow study instructions?
Do you have suitable general health to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new medicine, GEN3017, along with other supportive medicines like Prednisolone or Paracetamol, if needed, to help manage any side effects. These other medicines are well-known and often used in healthcare. The study will involve regular visits to the clinic for treatments, blood tests, physical exams, and other checks like scans to see how your body is reacting to the medicine and if the cancer is changing.

You'll be carefully monitored throughout the study to make sure you're safe and to track any effects of the treatment. The number of visits and the full length of the study will vary for each person, depending on how they respond to the treatment and what the doctors decide. There will also be follow-up appointments after you stop receiving the main study medicine to keep checking on your health and any long-term effects.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The main benefit here is the chance to receive a new medicine that isn't widely available yet, which might help your lymphoma when other treatments haven't worked. However, there's no guarantee the treatment will work for you, and it might not improve your condition. Like all medicines, GEN3017 could cause side effects, some of which might be serious. The research team will explain all the known risks and closely monitor you for any problems. Remember, joining is entirely your choice, and you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Germany
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Unverified
Denmark
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Unverified
Italy
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Unverified
Netherlands
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Unverified
France

Common questions

What is Hodgkin lymphoma and non-Hodgkin lymphoma?

These are types of cancer that start in white blood cells called lymphocytes, which are part of your immune system. They can affect different parts of your body.

What does 'relapsed or refractory' mean?

It means your lymphoma has either come back after you've had previous treatments, or it hasn't responded as expected to those treatments.

What 'phase' is this study?

It's a Phase 1 and Phase 2a study. This means it's an early-stage trial, focusing on finding a safe dose and seeing if the medicine works, as it's one of the first times it's being used in people.

Will I receive GEN3017, or a placebo?

In this study, you will receive the active treatment, GEN3017. There is no placebo arm in this trial.

What are the common side effects of treatments like this?

Early studies like this are designed to find out the side effects. The study team will closely monitor you and tell you about any side effects they observe, as well as how to manage them.