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

First-in-human, open-label, multicenter, Phase I/IIa, dose-escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors

This research is testing a new medicine called BNT142. It's for adults with advanced solid tumours that have a specific marker called CLDN6. This is one of the very first times BNT142 is being given to people. The main goals are to find out how safe the medicine is, what side effects it might cause, and to see if different doses work well. Researchers will slowly increase the dose to find the safest and most effective amount. They will also look at how much of the drug gets into the body and how long it stays there. Patients taking part will be carefully monitored for any improvements in their tumour size or growth.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

BioNTech SE

Enrolment target

119

Start

01 Jul 2024

Solid Tumors

What is this study about?

This study is looking into a new treatment called BNT142 for people who have advanced solid tumours. 'Advanced' means the cancer has grown or spread. The researchers are particularly interested in tumours that have a specific feature called CLDN6. They want to understand how BNT142 works in the body and if it can help patients.

This is a 'first-in-human' study, which means it's among the initial times this new medicine is being given to people. It's being carried out in stages. In the first stage, a small group of patients will receive very low doses of BNT142, which will then be slowly increased. This helps the doctors find the safest and most effective dose. In the later stages, more patients might get the medicine at the chosen dose to see how well it works against their tumours.

The main things the doctors will be looking for are any side effects patients experience and how severe they are. They will also keep a close eye on the size of the tumours to see if they shrink, stop growing, or if the cancer gets worse. This helps them understand if BNT142 could be a promising new treatment for these types of cancers.

Key takeaways

This is a new study testing a medicine called BNT142 for certain advanced solid tumours.
The medicine targets tumours with a specific marker called CLDN6.
Doctors will carefully check for safety, side effects, and if the treatment shrinks or stops tumour growth.
It's a 'first-in-human' trial, meaning it's early in the medicine's development.
Participation involves regular hospital visits, tests, and closely monitoring your health.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. Both men and women can take part.

You must have advanced solid tumours, which means the cancer has grown or spread. Importantly, your tumour needs to have a specific marker called CLDN6. Your doctor would check for this marker with tests if they think you might be suitable.

There will be other detailed health requirements that your hospital doctor will discuss with you to make sure the study is a safe and appropriate option 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 old or older?
Do you have a diagnosis of advanced solid tumour cancer?
Has your doctor confirmed that your tumour has the CLDN6 marker?
Are you able to attend regular hospital visits and appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive doses of the new medicine, BNT142. You will have regular hospital visits, especially at the beginning, so doctors can carefully monitor you. These visits will involve blood tests, physical examinations, and scans to check your general health and how the tumour is responding. The doctors will also ask you how you are feeling and if you have any side effects.

Initially, the study will involve slowly increasing the dose of BNT142 to find the best amount. This part is called 'dose escalation'. You may continue to receive the treatment for as long as it is safe and seems to be helping, and for a set period afterwards for follow-up checks. The total duration of your involvement in the study will depend on how your body responds to the treatment and your individual health.

Potential risks and benefits

Taking part in a trial like this might offer a chance to try a new medicine that isn't widely available yet, which could potentially help your condition if current treatments aren't working. However, as BNT142 is a new medicine, its full effects are not yet known. There's a risk of side effects, some of which could be serious. The research team will monitor you very closely for any issues, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Netherlands
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Unverified
Spain
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Unverified
Germany

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. It's a general term for many types of cancer.

What does 'advanced' mean in this study?

In this study, 'advanced' means the cancer has grown beyond its original site or has spread to other parts of the body.

What is CLDN6?

CLDN6 is a specific marker that can be found on some cancer cells. This study is testing a medicine designed to target cells with this marker.

Will I know if I'm getting the active drug or a dummy pill?

In this study, everyone receives the active drug, BNT142. There isn't a dummy pill (placebo) involved.

How often will I need to visit the hospital?

Initially, you'll likely have frequent visits for monitoring. Your study doctor will give you a detailed schedule based on the stage of the trial and your individual treatment plan.