Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A First in Human open label study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-Tumor Activity of VVD-130850 as Single Agent and in Combination with Checkpoint Inhibition in Participants with Advanced Solid and Hematologic Tumors.

This study is looking at a new investigational medicine called VVD-130850. It's the very first time this medicine is being given to people. The main goals are to check if it's safe to use and how well people tolerate it. Researchers will also learn how the body handles the medicine (how it’s absorbed, used, and removed) and if it has any effect on advanced cancers. This medicine will be tested both on its own and in combination with another type of cancer treatment. This is an early-stage study, meaning we are still learning a lot about this new potential treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Vividion Therapeutics Inc.

Enrolment target

Start

25 Mar 2024

Hematologic tumors Advanced solid tumors

What is this study about?

This study is an important first step in understanding a new medicine called VVD-130850. Imagine we have a new tool, and we want to see if it can help fix a problem. This study is like the very first test drive of that new tool in a real-world setting. Researchers will carefully give VVD-130850 to people who have advanced forms of cancer, which means cancers that have grown or spread.

The main aim is to learn if VVD-130850 is safe and if people can take it without severe problems. They'll also find out how the body processes the medicine – how long it stays in the body, and what happens to it. Another important part of the study is to see if the medicine shows any signs of fighting cancer, both when used alone and when combined with another common type of cancer treatment called checkpoint inhibition.

Because this is the first time VVD-130850 is being used in humans, it's called a 'Phase I' study. These early studies are crucial for gathering basic information about a new drug before it can be tested in larger groups of people. It helps determine if the medicine is promising enough to move forward with more research.

Key takeaways

This is an early study of a new medicine for advanced cancers.
The main goals are to check safety and how the medicine works.
It will be tested alone and with another cancer treatment.
Participants must be 18 or older with advanced solid or blood cancers.
Participation includes close medical monitoring but offers no guaranteed benefit.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. There is no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate in this research.

The study is specifically for individuals who have advanced solid tumours (like lung, breast, or bowel cancer that has spread) or hematologic tumours (cancers that affect blood, bone marrow, or lymph nodes, such as leukaemia or lymphoma).

There might be other specific health requirements or conditions that could affect whether you can join, which the study team will discuss with you. These are put in place to ensure your safety and that 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.

Are you 18 years old or older?
Do you have an advanced solid tumour (cancer that has grown/spread)?
Do you have a hematologic tumour (cancer of the blood or lymph system)?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

We don’t have detailed information about what taking part involves right now, as the brief summary didn't include it. However, generally, in early-stage studies like this, you would likely have regular visits to the hospital or clinic. These visits would include check-ups, blood tests, and scans to monitor your health and how the medicine is affecting you. You would receive the study medicine, VVD-130850, as directed by the study doctors. The doctors and nurses would carefully monitor you for any side effects. These kinds of studies can sometimes involve a commitment over several months, with follow-up appointments even after you stop taking the medicine.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new medicine that isn’t available outside the trial and close medical monitoring. However, there are also potential risks, including unknown side effects from the new medicine, which could be mild or serious. It's important to remember that not everyone will benefit from participating. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is VVD-130850?

VVD-130850 is a new medicine that is being tested for the first time in people to see if it can treat advanced cancers.

What does 'advanced solid and hematologic tumors' mean?

This refers to cancers that have grown or spread in different parts of the body (solid tumors) or cancers affecting the blood and lymph system (hematologic tumors).

What is a 'Phase I' study?

A Phase I study is the earliest stage of human testing for a new medicine, focusing on its safety and how it works in the body.

Will I definitely get better if I join this study?

There's no guarantee that participating will make you better. The main goal of this early study is to learn if the medicine is safe and shows any promise.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, and it will not affect your ongoing medical care.