Active not recruitingPHASE2INTERVENTIONAL

Study of INBRX-109 in Conventional Chondrosarcoma

This research study is looking into a new treatment called INBRX-109 for a specific type of bone cancer known as conventional chondrosarcoma. This cancer is either advanced (metastatic) or cannot be surgically removed (unresectable). The study aims to see how well INBRX-109 works and if it's safe compared to a placebo, which is a treatment that looks like the real medicine but contains no active drug. Participants will be randomly assigned to receive either INBRX-109 or the placebo, and neither they nor their doctors will know which treatment they are getting. This helps ensure the study results are as fair and accurate as possible. The study is in Phase 2, meaning it's still in the earlier stages of testing in people.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Inhibrx Biosciences, Inc

Enrolment target

206

Start

23 Sep 2021

Estimated completion

01 Dec 2026

Conventional Chondrosarcoma

What is this study about?

This study is about a type of bone cancer called conventional chondrosarcoma. This is a cancer that starts in the cartilage, which is the tough, flexible tissue found in your joints. Sometimes, this cancer can spread to other parts of the body (this is called metastatic) or it might be in a place where surgery isn't possible to remove it (this is called unresectable).

The researchers are testing a new medicine called INBRX-109. This medicine is designed to target specific cells in the body, which they hope will help fight the cancer. To understand if INBRX-109 works, they need to compare it to something else. In this study, they are comparing it to a "placebo." A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers see if any changes in health are truly due to INBRX-109 or something else.

This is a 'Phase 2' study. This means it's an important step where the medicine is given to a larger group of people than in earlier studies. The main goals are to check if the medicine is safe, what the right dose might be, and if it shows promise in treating the condition. By taking part, you could be helping to find new ways to treat conventional chondrosarcoma for people in the future.

Key takeaways

Tests a new medicine (INBRX-109) for conventional chondrosarcoma.
For cancer that has spread or can't be surgically removed.
Compares INBRX-109 to a dummy treatment (placebo).
Study participants are randomly assigned treatments, neither they nor doctors know which.
It's a Phase 2 study, focusing on safety and promising results.
Participation could help advance future treatments.

Who may be eligible?

This study is looking for adults aged 18 to 85 who have been diagnosed with a specific type of bone cancer called conventional chondrosarcoma. It's important that your cancer has either spread to other areas of your body, or it can't be removed by surgery. Also, doctors need to be able to measure your cancer on scans, and it must have shown some signs of growing or getting worse in the last six months.

You'll also need to be generally well enough to take part. This means your blood tests, liver, and kidney functions need to be within a healthy range, and your daily activities shouldn't be too affected by your condition. The study will also require a sample of your cancer tissue, either an old sample from a biopsy or a new one.

There are some reasons why you might not be able to join. For example, if you've had a similar type of treatment before, have certain allergies, or if you have other types of chondrosarcoma that are not the 'conventional' type. Other reasons for not joining include certain chronic liver diseases (unless it's fatty liver disease and your liver is still working well), or if you have multiple sclerosis or similar nerve conditions. Your doctor will carefully review all the criteria to see if this study is right 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.

Do I have conventional chondrosarcoma that has spread or can't be operated on?
Has my cancer shown recent signs of growing or getting worse?
Am I generally well enough, with healthy organ function?
Am I between 18 and 85 years old?
Do I have a tissue sample (biopsy) of my cancer available?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new medicine, INBRX-109, or a placebo (a dummy treatment). Neither you nor your doctor will know which one you are receiving. You will have regular visits to the clinic for assessments, including blood tests, scans to check your cancer, and to discuss how you are feeling. The study involves receiving the treatment, which will be given in a way that the study team will explain. You will have follow-up appointments after your treatment ends to monitor your health. The total duration of your participation, including treatment and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as gaining access to a new treatment that isn’t widely available yet, which might help manage your cancer. However, there are also potential risks, as with any new medicine. You might experience side effects from INBRX-109, or the placebo might not slow down your cancer. The research team will explain all known potential side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

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

Mayo Clinic Cancer Center
Verified postcode
Phoenix, United States
Precision NextGen Oncology & Research Center
Verified postcode
Beverly Hills, United States
University of California, San Francisco (UCSF)
Verified postcode
San Francisco, United States
Sarcoma Oncology Center
Verified postcode
Santa Monica, United States
University of Colorado
Verified postcode
Denver, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Mayo Clinic - Jacksonville
Verified postcode
Jacksonville, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Verified postcode
Chicago, United States
Rush Cancer Center
Verified postcode
Chicago, United States
University of Iowa
Verified postcode
Iowa City, United States
Johns Hopkins
Verified postcode
Baltimore, United States

Common questions

What is conventional chondrosarcoma?

It's a type of cancer that starts in the cartilage tissue, most commonly in the bones. The study focuses on this specific type.

What does 'unresectable or metastatic' mean?

Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread from where it started to other parts of your body.

What is a placebo?

A placebo looks like the study medicine but doesn't contain any active drug. It's used to compare against the real medicine to see if it's truly effective.

What is a Phase 2 study?

Phase 2 studies are an important step where a new medicine is given to a larger group of people to check its safety, find the right dose, and see if it shows promise against the disease.

Will I know if I'm getting the drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're receiving INBRX-109 or the placebo. This helps ensure fair and accurate results.