A trial looking at ginisortamab for pancreatic cancer that has spread

Cancer type:

Pancreatic cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at adding a new drug called ginisortamab to chemotherapy for pancreatic cancer that has spread to other parts of the body. Cancer that has spread is advanced or metastatic cancer. 

It is for people who haven’t yet had treatment for advanced pancreatic cancer. 

You pronounce ginisortamab as gin-ee-saw-ta-mab.  

Cancer Research UK supports this trial. 

More about this trial

You usually have chemotherapy for pancreatic cancer that has spread to other parts of the body. The chemotherapy drugs you might have include nab-paclitaxel and gemcitabine. Doctors are looking for ways to improve treatment for advanced pancreatic cancer. In this trial they are looking at adding a drug called ginisortamab to nab-paclitaxel and gemcitabine.

Ginisortamab (UCB6114) is a new drug. It is a targeted cancer drug Open a glossary item called a monoclonal antibody. It blocks a protein in the body called gremlin-1. 

Gremlin-1 is mainly found outside cancer cells. It stops nearby proteins that attack and kill cancer cells from working properly. Researchers think that blocking gremlin-1 will switch these proteins back on so they can attack cancer cells. And they hope this will help chemotherapy to work as it should. 

Early research shows that adding ginisortamab to chemotherapy might help people with cancer. Researchers now want to find out more about how well it works for people whose pancreatic cancer has spread.

The main aims of the trial are to find out:

  • the best dose of ginisortamab to have with nab-paclitaxel and gemcitabine
  • how safe it is to have ginisortamab in combination with nab-paclitaxel and gemcitabine
  • if adding ginisortamab to chemotherapy improves treatment
  • more about the side effects 
  • what happens to ginisortamab in the body

Who can enter

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 Open a glossary item) 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 Open a glossary item 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 Open a glossary item) 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 Open a glossary item 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 Open a glossary item, non muscle invasive bladder cancer or carcinoma in situ (CIS) Open a glossary item 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 Open a glossary item  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 Open a glossary item 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 Open a glossary item 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 

Trial design

This phase 2 trial is taking place in the UK and Europe. The team need between 6 and 36 people to join the first part of the trial and 60 people to join the second part. 

Everyone has ginisortamab with nab-paclitaxel and gemcitabine chemotherapy.

There are 2 parts to this trial.

Part one (safety run in) 
This is the only part open at the moment.  

This is the first time people are having ginisortamab alongside gemcitabine and nab-paclitaxel. Researchers want to make sure it is safe to use ginisortamab alongside these chemotherapy drugs. 

In this part, the first few people have the recommended dose of ginisortamab. This is the best dose found in the phase 1 trial. The team can reduce this dose if people have severe side effects. The safety run in helps the researchers to find the best dose of ginisortamab alongside gemcitabine and nab-paclitaxel. 

Part 2 (dose expansion)
Part 2 will test the best dose found in part 1 in more people. This part isn’t open yet. 

How you have treatment 
You have all your treatment as a drip into a vein. You have treatment in cycles Open a glossary item. Each 4 week period is a cycle of treatment. 

You have ginisortamab once every 2 weeks and then you have 2 weeks when you don’t have it. It takes about 30 minutes each time. You have this for up to 12 cycles as long as it is working and the side effects aren’t too bad. 

You have nab-paclitaxel and gemcitabine chemotherapy once a week for 3 weeks and then you have 1 week with no chemotherapy. Your team will tell you how long you have chemotherapy for. 

You have nab-paclitaxel and gemcitabine as two separate drips. Each drug takes about 30 minutes each time. 

You continue on the trial even if you stop having either ginisortamab or chemotherapy. You stay on the trial until you stop having both ginisortamab and chemotherapy. Your doctor will then talk to you about other treatment options.

Quality of life
The trial team ask you to fill out a questionnaire:

  • before you start treatment
  • at set times during treatment
  • at set times after treatment 

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Samples for research 
The researchers might ask to take extra tissue samples (biopsies Open a glossary item). They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others
  • see what happens to ginisortamab in the body 
  • see how well the treatment is working 

You need to agree to have the extra tissue samples taken if the trial team ask for these. Not everyone in the trial will need to have these samples taken. 

Hospital visits

You see the doctor to have some tests before taking part. These include:

  • a physical examination Open a glossary item
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • a CT scan or MRI scan 

You have all your treatment at the hospital in the outpatient department. You shouldn’t need to stay overnight. Some hospital visits will take a few hours but some visits will be longer. The trial team can tell you more about this. 

You see the doctor regularly while you are having treatment. This is for blood tests and to see how you are. 

You have a CT scan or MRI scan one month after you start treatment. After that, you have them once every 8 weeks. You stop having the trial scans if your cancer gets worse. 

You see the trial doctor for a check up 14 days after you finish treatment. 

Follow up
The team follow you up every 3 months when you finish treatment. You might see them at a routine hospital appointment or they may call you to see how you are getting on. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

A few people have had ginisortamab as part of another clinical trial. This trial is still ongoing so we don’t know about all the side effects yet. The possible side effects of ginisortamab we know about so far include:

  • blood clots
  • a reaction to the drug. These reactions include fevers, chills, swelling, stiff muscles or difficulty breathing
  • feeling or being sick 
  • diarrhoea, tummy pain or both 
  • developing another cancer

This is the first time people are having ginisortamab with gemcitabine and nab-paclitaxel. The side effects may be worse when you have this chemotherapy with ginisortamab. We have information about the side effects of nab-paclitaxel and gemcitabine. 

Your doctor will talk to you about all the possible side effects of treatment before you agree to join the trial. 

Location

Glasgow

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Jeff Evans 

Supported by

Cancer Research UK (Centre for Drug Development)
UCB Biopharma SRL

Other information

This is Cancer Research UK trial number CRUKD/24/002.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19221

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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