A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
This research study is looking into a new treatment called CRB-701 for adults with advanced solid cancers that have a specific marker called nectin-4. The main goals are to find a safe and effective dose of CRB-701, and to see which types of cancer respond best to it. The study is split into different parts, starting with finding the right dose and then exploring how well it works, sometimes in combination with another cancer drug called anti-PD-1. Participants will receive the study medicine through a drip and have regular check-ups, including blood tests and scans, to monitor their health and the treatment's effects. It's for people whose previous treatments haven't worked or who have no other standard treatment options.
At a glance
What is this study about?
This research study is exploring a new treatment called CRB-701 for adults who have advanced solid cancers. These are cancers that have grown or spread and have a specific feature on their cells called 'nectin-4'. The main aim of the study is to figure out the right amount (dose) of CRB-701 that is both safe and works well against these cancers. It also wants to understand which specific types of cancer might benefit most from this new medicine.
The study is divided into three main parts. The first part focuses on finding the safest and most effective dose of CRB-701. The second part will look at different doses of CRB-701, sometimes given alone and sometimes with another cancer medicine called anti-PD-1, to see how well they work. Finally, the third part will take the best dose found and test it more widely across different groups of participants with Nectin-4 positive cancers, again either alone or with anti-PD-1.
Taking part in this study means you would receive CRB-701 as an infusion (through a drip). You would also have various tests, like blood tests and scans (CT or MRI), to help the doctors understand how the treatment is affecting you and your cancer. This approach helps the researchers gather important information to see if CRB-701 could become a new option for treating these cancers.
Key takeaways
- Tests a new medicine, CRB-701, for advanced solid cancers with a specific marker (nectin-4).
- Aims to find a safe and effective dose, and see which cancers respond.
- Participants receive CRB-701 via a drip and have regular check-ups, blood tests, and scans.
- May involve another cancer drug, anti-PD-1, in later parts of the study.
- For adults who have tried other treatments or have limited options.
- You can withdraw from the study at any time.
Who may be eligible?
This study is for adults aged 18 and over, with any gender, who have advanced solid cancers that have a specific marker called 'nectin-4'. You might be able to join if your cancer has grown despite previous treatments, or if there are no other standard treatments proven to work for your type of cancer. For certain head and neck cancers (HNSCC) specifically, you might be able to join even if it's your first time receiving treatment.
However, there are some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain or spinal cord and isn't under control, or if you've had other types of cancer in the past (not including the one being studied). You also can't join if you’ve had heart problems in the last six months, if you have severe numbness or tingling (neuropathy) that's already quite bad, or if you have uncontrolled diabetes or certain liver or lung conditions. The study doctors will carefully check all your health conditions to make sure it's safe for you to take part.
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 cancer that has proven to have the 'nectin-4' marker?
- Has your cancer progressed despite usual treatments or are there no standard effective treatments available?
- Have you been free from serious heart problems in the last six months?
- Do you have well-controlled diabetes if you have it, with an HbA1C below 8%?
- Do you not have active, uncontrolled cancer spread to your brain or spinal cord?
What does participation involve?
If you join this study, you will receive the new medicine, CRB-701, through a drip into your vein. You'll need to visit the clinic regularly for these infusions and for various health checks. These checks will include blood tests to see how your body is reacting and how the medicine is affecting your blood. You will also have scans, like CT or MRI scans, to see if the treatment is affecting your cancer.
The specific number of visits and the overall length of your participation will depend on which part of the study you are in and how you respond to the treatment. The research team will explain the full schedule to you in detail. There will also be follow-up appointments to monitor your health once the main treatment period is over. All treatments and assessments will be planned and guided by the study doctors.
Potential risks and benefits
Locations (41)
- O'Neal Comprehensive Cancer Center at University of Alabama-BirminghamVerified postcodeBirmingham, United States· Recruiting
- City of Hope Cancer CenterVerified postcodeDuarte, United States· Recruiting
- Moores Cancer Centre at UC San Diego HealthVerified postcodeSan Diego, United States· Recruiting
- Helen Diller Family Comprehensive Cancer Center - UCSFVerified postcodeSan Francisco, United States· Recruiting
- Rocky Mountain Cancer CentresVerified postcodeDenver, United States· Active not recruiting
- Yale Cancer CenterVerified postcodeNew Haven, United States· Recruiting
- Florida Cancer SpecialistsVerified postcodeOrlando, United States· Recruiting
- University of ChicagoVerified postcodeChicago, United States· Recruiting
- Hope and Healing Cancer CenterVerified postcodeHinsdale, United States· Active not recruiting
- Dana-Faber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Nebraska Hematology OncologyVerified postcodeLincoln, United States· Active not recruiting
- Carolina BioOncology InstituteVerified postcodeHuntersville, United States· Active not recruiting
Common questions
What is 'nectin-4' and why is it important for this study?
Nectin-4 is a specific protein found on some cancer cells. This study is focusing on cancers that have this protein because CRB-701 is designed to target it.
What does 'advanced solid tumors' mean?
This refers to cancers that have grown beyond their original site or have spread to other parts of the body. 'Solid tumors' are cancers that form a lump or mass, like breast cancer or lung cancer, rather than blood cancers.
Will I definitely receive CRB-701 if I join?
Yes, if you meet all the study requirements and agree to take part, you will receive CRB-701, possibly in combination with another medicine called anti-PD-1, depending on the study part.
What is an 'infusion'?
An infusion means the medicine is given slowly into your bloodstream, usually through a small tube inserted into a vein in your arm, similar to a drip.
What are 'blood tests' and 'scans' for?
Blood tests help doctors check your general health and how the medicine is affecting your body. Scans like CT or MRI help them see if the cancer is shrinking or changing.
How to find out more
Ian Hodgson, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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