A trial looking at ozekibart (INBRX-109) for people with chondrosarcoma (ChonDRAgon)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have a primary bone cancer  called conventional chondrosarcoma that has either spread to another part of the body or cannot be removed by surgery with the aim to cure
• have a sample of tissue (biopsy ) that the trial team can ask for a piece of and is suitable to use. If this is not available, you must be willing to have a new biopsy taken. 
• have an area of cancer that the doctor can measure 
• had a scan within 6 months of starting the trial treatment that shows your cancer is getting worse
• have satisfactory blood test results
• can look after yourself and are active but might not be able to do heavy physical work (performance status 0 or 1)
• are willing to use reliable contraception during the trial and for a period of time after if there is any chance you or your partner could become pregnant
• are between 18 and 85 years old

Who can’t take part

Cancer related

You cannot join this trial if any of these apply. You:

• have a rare type of chondrosarcoma called non conventional chondrosarcoma
• have signs of cancer spread to the brain, the tissue surrounding the brain or the spinal cord. This is apart from cancer spread that is controlled and you don’t need to have steroids . You might also be able to take part if the cancer has only spread to the spinal cord. 
• have or had another cancer. This is apart from certain ones that your doctor will know about.
• have had a drug called a DR5 agonist
• have had any cancer treatment within 4 weeks of starting trial treatment. This includes experimental drugs used as part of another clinical trial. 
• have radiotherapy within 4 weeks of starting trial treatment. For radiotherapy for symptom control (palliative radiotherapy) it is 1 week unless it was to the brain or spinal cord.
• have ongoing side effects of radiotherapy or you are taking steroids for radiotherapy side effects 
• have moderate to severe side effects from past cancer treatments. You may be able to take part if you have hair loss, mild numbness and tingling in your hands and feet (peripheral neuropathy) or low numbers of a type of white blood cell called lymphocytes in your bloodstream (lymphopenia)
• have had a stem cell or bone marrow transplant from a donor (allogeneic transplant ) within the past 5 years. You might be able to take part if you had a stem cell or a bone marrow transplant more than 5 years ago and you have no symptoms of graft versus host disease (GvHD)
• had treatment for cancer in the liver, such as radiofrequency ablation (RFA) , trans-arterial chemoembolization (TACE), cryotherapy , stereotactic body radiation therapy (SBRT) , within a year of starting trial treatment
• had radioembolisation  using Yttrium-90 beads to treat liver cancer. Your doctor will know this. 

Medical conditions

You cannot join this trial if any of these apply. You:

• have ongoing liver problems
• are 45 years or older and your fatty liver scores are over a certain amount
• had liver damage or inflammation (toxic liver disease) caused by substances such as medication within the year before starting trial treatment 
• are 65 years or older and have a body mass index (BMI)  of 30 or more
• had a viral infection such as hepatitis A, hepatitis D, hepatitis E, CMV or EBV within the year before starting trial treatment
• have an infection that needed treatment within 2 weeks of taking part in the trial
• have or had hepatitis B, hepatitis C or HIV
• have major surgery within 4 weeks of taking part in the trial
• have a blood clot (DVT)
• have a blood clot in the lung (pulmonary embolism) that has not gone away or has not been stable for at least 3 months of starting trial treatment
• have type 2 diabetes that is not controlled by medication or you have health problems that mean you are at a greater risk of developing diabetes
• have an under active thyroid gland (hypothyroidism) that is not controlled by medication
• have high blood pressure (hypertension) that is not controlled by medication
• have too many fats called triglycerides in your blood, and it is not controlled by medication
• have a level of oxygen in your blood that is below 92%
• have changes in how your brain works that can make you feel confused, restless or not like yourself
• have or had multiple sclerosis (MS) or another disease that affects the myelin sheath of the nerves affecting how well the nerves work
• have another medical condition, mental health condition or any other reason that could affect you taking part in a clinical trial 

Other

You cannot join this trial if either of the following apply. You:

• are allergic or sensitive to ozekibart or how it is made
• are pregnant or breastfeeding