RecruitingPHASE1, PHASE2INTERVENTIONAL

First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

This research is looking into a new treatment called CRB-601 for people with advanced solid tumors (cancer) that haven't improved with other therapies. CRB-601 is a special type of drug designed to target specific proteins found on some cancer cells. Researchers want to see if CRB-601 is safe when given alone or with other cancer medicines (immunotherapy), what dose works best, and if it has a positive effect on the cancer. They will also check for side effects and how CRB-601 behaves in the body. The goal is to find new and more effective ways to treat difficult-to-treat cancers.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Corbus Pharmaceuticals Inc.

Enrolment target

156

Start

04 Dec 2024

Estimated completion

01 Dec 2026

Solid Tumor

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test new medicines or treatments in people. The main focus is on a new drug called CRB-601. This drug aims to fight cancer by targeting a specific protein called avb8 integrin, which is found on certain solid tumor cells. The study will bring together CRB-601 with other existing cancer treatments, like immunotherapy, which helps your body's immune system fight cancer.

The main reasons for doing this study are to: 1) check if CRB-601 is safe; 2) understand what dose works best and how it moves through your body; and 3) see if it can help shrink tumors or stop them from growing, especially for people whose cancer hasn't responded to other treatments. The researchers are particularly interested in cancers that have high or medium levels of the avb8 integrin protein.

By carefully studying these things, researchers hope to learn if CRB-601, either alone or with other treatments, could be a new and effective way to help people with advanced solid tumors.

Key takeaways

This study is testing a new drug (CRB-601) for advanced solid tumors.
It aims to find safe doses and check if the drug helps fight cancer.
CRB-601 targets a specific protein found on some cancer cells.
It will be given as a drip, possibly with existing immunotherapy.
Regular health checks and scans will monitor your progress and safety.
Participation involves ongoing visits as long as the treatment is beneficial.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with advanced solid tumors. Your cancer must have either progressed after you've already had at least one other treatment, or there are no other standard treatments available that have been proven to work for your specific condition.

To be considered, your cancer needs to be measurable on scans. You should also be generally well enough to take part in the study, which means having a good life expectancy (more than 12 weeks) and healthy levels in your blood tests, as well as good organ function.

Important reasons why you might not be able to join include having certain other cancers in the past three years, serious heart problems, severe liver disease, certain immune system conditions, blood clotting issues, uncontrolled bleeding or diabetes, or lung conditions in the last six months. The study doctors will carefully review your health to make sure it's safe for you to participate.

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 advanced solid tumor cancer?
Has your cancer progressed after other treatments, or are there no other standard treatments available?
Is your cancer measurable on scans?
Do you have good general health and organ function (e.g., healthy blood test results, no major heart or liver problems)?
Have you discussed any past or current major health issues with your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, CRB-601. It will be given through a drip into your vein (an infusion) every two weeks. Depending on which part of the study you are in, you might receive CRB-601 on its own, or combined with another cancer medicine called immunotherapy.

You will have regular check-ups to monitor your general health, have blood tests, and discuss any side effects you might be experiencing. You'll also have regular scans, like CT or MRI scans, to see how the treatment is affecting your cancer. You'll continue to visit the clinic every two weeks as long as the treatment is helping you. If your cancer starts to progress, you will still be asked to stay in touch with the researchers so they can understand the long-term results, even if you start other treatments.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as gaining access to a new treatment like CRB-601 before it's widely available. It also contributes valuable information that could help others in the future. However, there are potential risks, as new drugs can have side effects that aren't fully known yet. Your health will be closely monitored for any reactions or side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Not yet recruiting
SCRI - Arizona Oncology Associates
Verified postcode
Tucson, United States· Not yet recruiting
The University of Arizona Cancer Center
Verified postcode
Tucson, United States· Not yet recruiting
UC San Diego Health - Moores Cancer Center
Verified postcode
La Jolla, United States· Not yet recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Not yet recruiting
SCRI - Rocky Mountain Cancer Centers
Verified postcode
Denver, United States· Not yet recruiting
Advent Health Oncology Hematology
Verified postcode
Orlando, United States· Not yet recruiting
SCRI- Lake Nona DDU
Verified postcode
Orlando, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Not yet recruiting
SCRI - Minnesota Oncology Hematology
Verified postcode
Maple Grove, United States· Not yet recruiting
Nebraska Hematology Oncology
Verified postcode
Lincoln, United States· Recruiting

Common questions

What is a 'solid tumor'?

A solid tumor is a lump or mass formed by abnormal growth of cells. It's different from blood cancers like leukaemia.

What does 'advanced' mean in this study?

Advanced means the cancer has grown or spread from where it started, and it has not responded to other treatments given before.

What is 'immunotherapy'?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer cells more effectively.

Will I know if I'm getting CRB-601 alone or with immunotherapy?

Yes, your study doctor will explain which specific treatment plan you would be on, based on the study design.

What happens if the treatment doesn't work for me?

If your cancer progresses, you'll still be asked to continue follow-up with the researchers to understand the long-term outcomes, even if you move on to other treatments.

How to find out more

Ian Hodgson, PhD

ian.hodgson@corbuspharma.com 617-963-0100 Official trial record

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