RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

This research is looking into a new medication called VVD-133214 for people with certain advanced solid tumours. This includes a specific type of bowel cancer. The main goals are to see how safe the drug is, how well the body takes it in and uses it, and if it shows any signs of shrinking tumours. It's an early-stage study, meaning it's one of the first times this drug is being tested in humans. Researchers will test VVD-133214 by itself and sometimes alongside other established treatments like pembrolizumab or bevacizumab. It's specifically for tumours that have certain genetic changes called microsatellite instability (MSI) or deficient mismatch repair (dMMR), which are thought to make them more likely to respond to this new drug.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Vividion Therapeutics, Inc.

Enrolment target

280

Start

25 Jan 2024

Estimated completion

31 May 2027

Advanced Solid Tumors Colorectal Cancer

What is this study about?

This study is investigating a new oral medicine, VVD-133214, for people who have advanced solid tumours. This means the cancer has spread or cannot be removed by surgery. This particular drug is designed to target a specific protein in cancer cells called Werner (WRN). Some cancers, especially those with certain genetic features like 'microsatellite instability' (MSI) or 'deficient mismatch repair' (dMMR), might rely on this WRN protein to grow. By blocking this protein, VVD-133214 aims to stop or slow down the cancer's growth.

This is a 'first-in-human' study, which means it's one of the initial times this drug is being tested in people. Because of this, the main focus is on safety: understanding any side effects and finding the right dose. Researchers will also look at how the body processes the medication and if there are any early signs that it's helping to shrink tumours. They will test VVD-133214 on its own and also in combination with two other commonly used cancer medicines, pembrolizumab or bevacizumab, depending on the type of cancer.

The study involves different types of advanced solid tumours, with a particular focus on bowel cancer (colorectal adenocarcinoma) that has these specific MSI or dMMR features. The information gathered from this study will help decide if VVD-133214 could be a promising new treatment option that deserves further research in larger studies.

Key takeaways

This study is testing a new drug for advanced cancers with specific genetic changes.
It's an early-stage study focused on safety, but also looking for signs of tumour shrinkage.
The new drug targets a protein that may help certain cancers grow.
It can be taken on its own or with other standard cancer treatments.
Participation requires regular hospital visits and health monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old and generally well enough to take part. This includes being able to perform most daily activities and not feeling too tired. Your cancer must be advanced, meaning it cannot be removed with surgery or has spread, and it should have specific genetic changes called MSI or dMMR. You would also have already tried and not responded well to, or couldn't tolerate, standard treatments for your advanced cancer. Importantly, your doctors must be able to see and measure your tumour.

For those with bowel cancer, the rules are slightly different. If you are taking VVD-133214 with bevacizumab, you would have had 2 or 3 previous treatments for your advanced bowel cancer. If you are taking it with pembrolizumab, your bowel cancer would be advanced and not suitable for surgery, and you would not have had any previous systemic treatment for your advanced cancer.

There are also some reasons you wouldn't be able to join. These include not being able to swallow pills, or having other conditions that might affect how your body absorbs medication. Also, if you have certain brain tumours that are causing problems, or if you have uncontrolled infections, you might not be able to participate. You would also need to be able to provide a tissue sample from your tumour.

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 at least 18 years old?
Do you have an advanced solid tumour that has specific MSI or dMMR changes?
Are you generally well enough to manage most daily activities?
Have you already tried and not responded to, or couldn't tolerate, standard treatments for your advanced cancer?
Can you swallow pills comfortably?
Do you have a tumour that doctors can measure?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given the new drug VVD-133214, which is taken by mouth as pills. Depending on the part of the study you are in, you might also receive pembrolizumab or bevacizumab, which are given as infusions directly into your bloodstream. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These assessments will help the doctors understand the drug's safety and effectiveness. The study will continue as long as you are benefiting from the treatment and tolerating it well, or until your doctor decides it's no longer the best option. The total duration of participation will vary for each individual, depending on their response to the treatment.

Potential risks and benefits

Participating in a clinical trial like this may offer the potential benefit of accessing a new treatment before it's widely available. While VVD-133214 might help slow down or shrink your cancer, it's also possible it may not work for you. As with any new medicine, there are potential risks and side effects, some of which may be serious, and these will be carefully explained to you by the study team. Your health will be closely monitored throughout the study. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (29)

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

City of Hope Cancer Center
Verified postcode
Duarte, United States· Recruiting
City of Hope at Irvine Lennar
Verified postcode
Irvine, United States· Recruiting
Emory University School of Medicine
Verified postcode
Atlanta, United States· Recruiting
Norton Cancer Institute - MDC
Verified postcode
Louisville, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States· Recruiting
Duke University
Verified postcode
Durham, United States· Completed
Oklahoma University Health Sciences Center
Verified postcode
Oklahoma City, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
St Vincents Sydney
Verified postcode
Darlinghurst, Australia· Active not recruiting
Alfred Hospital
Verified postcode
Melbourne, Australia· Recruiting
UZ Leuven Gasthuisberg
Verified postcode
Leuven, Belgium· Active not recruiting

Common questions

What is a 'first-in-human' study?

It means this is one of the very first times this specific drug is being tested in people. The main aim is to check its safety and how the body handles it.

What does 'advanced solid tumour' mean?

It means the cancer has spread from where it started (metastatic) or cannot be completely removed by surgery.

What are MSI and dMMR?

These are specific genetic changes found in some cancer cells. They can sometimes indicate that a cancer might respond better to certain treatments.

Will I definitely get the new drug?

Yes, everyone in this study will receive the new drug VVD-133214, either on its own or in combination with other approved cancer treatments.

What kind of commitment is involved?

You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're doing and how the treatment is working.

How to find out more

Vividion Clinical Trial Call Center

clinicaltrials@vividion.com 1+ 858-345-9752 (U.S. Only) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.