A trial looking at ginisortamab for pancreatic cancer that has spread

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 the most common type of pancreatic cancer called ductal adenocarcinoma of the pancreas that has spread to other parts of the body 
• have a sample of cancer tissue (biopsy ) that the trial team can access or you are willing to have a new sample taken before you join the trial. You must also be willing to have a sample of tissue taken while you are having treatment.
• have cancer that your doctor can measure on a scan 
• are well enough to carry out your normal activities but you might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results 
• are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
• are willing not to donate sperm during the trial and for a period after 
• are at least 18 years old 

Who can’t take part

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

• have cancer that has spread to the brain or membranes that surround the brain
• have had chemotherapy for cancer that can’t be removed with surgery 
• have already had radiotherapy to the only area of cancer that the doctors can measure on a scan. You may be able to take part if the area of cancer has got worse since you completed radiotherapy. 
• have had radiotherapy for metastatic  pancreatic cancer and this was within 6 months of joining the trial. You may be able to take part if you had radiotherapy to treat symptoms (palliative radiotherapy ) and this was completed within 7 days of the first dose of ginisortamab.
• have had chemotherapy for pancreatic cancer that can’t be removed with surgery, you have had chemotherapy for pancreatic cancer that hasn’t spread with the aim to cure in the last 6 months or you have had any other cancer treatment in the last 28 days before starting trial treatment. You can take part if the cancer has now come back and spread and it was more than 6 months since you had chemotherapy.  You may also be able to take part if you had certain types of chemotherapy before radiotherapy. Your doctor will check this. 
• have had an experimental treatment for pancreatic cancer that has spread within 28 days of starting trial treatment 
• have had another cancer treatment within a month of having treatment in this trial or it hasn’t cleared your body yet. Your doctor will know this. 
• have neuroendocrine cancer of the pancreas or acinar pancreatic cancer. Your doctor will know this. 
• have had mitomycin C chemotherapy or you have had a type of drug called a nitrosourea within 6 weeks of starting ginisortamab 
• have side effects from past treatments that aren’t getting better that your doctor thinks could affect you taking part in the trial 
• are taking part in another trial that involves a treatment
• have or had another cancer. You can take part if you had non melanoma skin cancer , non muscle invasive bladder cancer or carcinoma in situ (CIS)  that has been successfully treated. You may also be able to take part if you have prostate cancer that hasn’t spread. 

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

• have had a heart attack in the last 6 months or another significant heart problem   that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• have a collection of fluid on the lungs or tummy (abdomen)
• have interstitial lung disease, scarring of the lung or any other severe lung condition 
• have had a clot on the lung or in your leg. You can take part if you are still having treatment for this. 
• have had major surgery to the chest or tummy and you aren’t better yet 
• have HIV, an active hepatitis B or hepatitis C infection or another infection that isn’t well controlled with medication 
• have a problem with how your immune system  works or you are taking medication to damp down the immune system unless it is a low dose
• have any other medical condition or mental health problem that could affect you taking part 

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

• have had a live vaccine  within 28 days of starting treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
• are having a herbal treatment that could affect how ginisortamab works. Your doctor will know this.
• are pregnant or breastfeeding