AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A study testing a new treatment called TK-6302 for the first time in people with advanced cancers that have a genetic marker called HLA-A02:01 and a tumour protein called PRAME.

This important study is looking at a new medicine called TK-6302 for advanced cancers. These are cancers that have spread or are difficult to treat, and they have two specific features: a genetic marker called HLA-A02:01 and a protein called PRAME on the cancer cells. This is the very first time TK-6302 is being given to people, so the main aim is to carefully check if it is safe and how the body handles it. This early research is a vital step in developing new treatments, and the hope is that TK-6302 could one day offer a new option for people with these specific types of cancer. All participants must be over 18 years old.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

T-Knife GmbH

Enrolment target

Start

27 Feb 2026

Advanced PRAME Positive Solid Tumors

What is this study about?

This study is a very early stage of research, sometimes called a Phase 1 study. Its main purpose is to see if a new medicine, TK-6302, is safe and can be tolerated by people. Researchers will also learn how the medicine behaves in the body. They are particularly interested in people with advanced cancers that have two specific characteristics: a genetic marker on their cells called HLA-A02:01, and a particular protein called PRAME on the cancer cells themselves. These specific features are like a unique signature for these cancer cells.

Finding new ways to treat cancer is a continuous journey. Medicines like TK-6302 are designed to target specific features of cancer cells. If this medicine proves safe and shows some promising activity, it could open the door for further research to explore its potential to help more people in the future. Because it's the first time TK-6302 is being used in humans, the researchers will be extra careful and monitor participants closely.

The information gathered from this study is crucial. It helps doctors understand if the new medicine has potential to become a useful treatment for advanced cancers with these specific markers. Every step in this process brings us closer to better understanding and, hopefully, better treatments for cancer.

Key takeaways

This study is testing a new medicine (TK-6302) for the very first time in people.
It's for advanced cancers with specific markers called HLA-A02:01 and PRAME.
The main goal is to check for safety and how the medicine works in the body.
Participation involves close monitoring, regular visits, and taking the new medicine.
It could offer a potential new treatment option for specific cancers.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to both men and women.

Another important requirement is that participants must have an advanced cancer. This means the cancer may have spread or is difficult to treat with standard therapies. More specifically, the cancer must have a special genetic marker called HLA-A02:01 and also show a protein called PRAME on the cancer cells. Your doctor will be able to check if your cancer has these specific features.

The researchers will also have other strict rules about who can join, which will be carefully explained by the study team. These rules are put in place to ensure the safety of everyone taking part and to make sure the study results are clear.

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.

Am I 18 years old or older?
Do I have a diagnosis of advanced cancer?
Has my doctor confirmed that my cancer has the HLA-A02:01 marker?
Has my doctor confirmed that my cancer has the PRAME protein?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine called TK-6302. Because this is the first time this medicine is being given to people, you would be monitored very closely by the study team. This would involve regular visits to the hospital or clinic for check-ups, blood tests, and other assessments to see how you are responding to the treatment and to check for any side effects.

These visits might be quite frequent at the beginning of the study. The doctors would also likely perform scans or other tests to monitor your cancer. The total length of your participation would depend on how your body responds to the medicine and if you experience any side effects. You would continue to receive the study medicine as long as it is safe and potentially beneficial, with regular follow-up appointments even after stopping the treatment.

Potential risks and benefits

Any new medicine comes with possible benefits and risks. For this study, the potential benefit is that TK-6302 might help control your cancer, even if it's in its early stages of testing. However, because it's a new medicine, there might be side effects that are not yet fully known. The study team will carefully explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

—
Unverified
Germany

Common questions

What does 'advanced cancer' mean in this study?

In this study, 'advanced cancer' usually means cancer that has spread to other parts of the body or has come back after previous treatments. Your doctor can tell you if your cancer fits this description.

What are 'HLA-A02:01' and 'PRAME'?

These are specific features that must be present in your cancer for you to join this study. HLA-A02:01 is a genetic marker, and PRAME is a protein found on cancer cells. Your doctors would test your cancer to see if it has these.

Is this medicine available outside of the study?

No, TK-6302 is a new investigational medicine, which means it is only available to patients taking part in this specific clinical trial.

How long would I be in the study if I join?

The length of time you'd be in the study can vary. It depends on how you respond to the medicine and if you experience any side effects. The study team will discuss this with you in detail.

Will I definitely get the new medicine?

Yes, in this type of study, all participants who meet the criteria would receive the new medicine TK-6302. This allows researchers to see how it works in people.