RecruitingPhase IIInterventional

A Phase II trial of ginisortamab in participants with metastatic pancreatic ductal adenocarcinoma

This study is testing an experimental medicine called ginisortamab for adults with pancreatic cancer that has spread to other parts of the body (metastatic pancreatic cancer). Pancreatic cancer cells often turn off natural body signals that normally stop tumours from growing. Ginisortamab works by blocking a protein called gremlin-1. Researchers hope this turns the protective signals back on, making cancer cells more sensitive to standard treatments. The trial tests ginisortamab in two groups. The first group receives it alongside standard chemotherapy. The second group includes people whose cancer stayed stable or shrank after chemotherapy; they receive ginisortamab with another targeted drug called cobimetinib, or routine observation. Researchers want to find the best dose, check how safe it is, monitor side effects, and see if it improves treatment results.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Cancer Research UK

Enrolment target

156

Start

25 Jun 2024

Estimated completion

31 Oct 2028

Metastatic pancreatic ductal adenocarcinoma

What is this study about?

Pancreatic cancer can be difficult to treat, especially when it has spread beyond the pancreas. In healthy tissue, the body produces natural proteins that help stop abnormal cells from growing out of control. However, pancreatic tumours often produce another protein called gremlin-1. Gremlin-1 blocks these natural defences, allowing the cancer to grow and resist treatments.

Ginisortamab is a new drug designed to target and block gremlin-1. By blocking this protein, researchers hope to switch the body's natural anti-cancer signals back on. This may make the cancer cells weaker and more sensitive to chemotherapy and other targeted therapies.

This trial is divided into two parts, known as modules. Module 1 tests ginisortamab combined with standard chemotherapy in people who are just starting treatment. Module 2 tests ginisortamab alongside a targeted medicine called cobimetinib as a 'maintenance' therapy for people whose tumours have already responded to or remained stable on standard chemotherapy. The trial aims to find the safest dose, understand any side effects, and see if this new approach helps control the disease for longer.

Key takeaways

Tests a new medicine (ginisortamab) for pancreatic cancer that has spread.
Aims to make cancer cells more sensitive to chemotherapy and targeted therapies.
Involves regular hospital visits for IV drips, blood tests, scans, and tissue biopsies.
Open to adults aged 18 and over who meet specific fitness and health criteria.
Participation is completely voluntary and closely supervised by cancer specialists.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with pancreatic ductal adenocarcinoma that has spread to other parts of the body (metastatic cancer). To join, you must be well enough to carry out light daily activities and your regular blood test results must be within safe limits.

For Module 1, participants are usually those who are about to start their first round of standard chemotherapy. For Module 2, participants must have completed at least 16 weeks of standard chemotherapy, and scans must show that their cancer has shrunk or remained stable.

You will also need to be able and willing to have small tumour samples (biopsies) taken safely before and during the study, as these help doctors see how the drug is working in your body. Your oncology team will review your full medical history to check if the trial is safe and appropriate for you.

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.

I am aged 18 or older.
I have been diagnosed with pancreatic ductal adenocarcinoma that has spread (metastatic).
I am well enough to walk around and manage my own personal care (ECOG performance status 0 or 1).
I am willing and able to undergo safe tumour biopsies before and during treatment.
If considering maintenance therapy (Module 2), my cancer has not grown after at least 16 weeks of first-line chemotherapy.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will receive your treatment at a specialist cancer hospital. Ginisortamab is given directly into a vein through a drip (intravenously). Depending on which part of the study you join, you will receive it alongside standard chemotherapy drips or together with a daily tablet called cobimetinib.

Before starting and during the study, you will have regular hospital visits for health checks. These include blood tests, physical examinations, heart checks, and imaging scans (such as CT scans) to check on your tumour. You will also have small tissue samples (biopsies) taken from the tumour if it is safe to do so.

In Module 2, participants are randomly chosen by a computer to either receive the study treatment or enter a period of close monitoring without study medication. You can stay on the trial for as long as the treatment is helping you and side effects remain manageable. The overall study will run until late 2029.

Potential risks and benefits

A potential benefit is that the study drug might help slow or shrink your cancer, and taking part helps doctors discover better treatments for people in the future. However, because ginisortamab is a new medicine, there is no guarantee it will improve your health. You may also experience side effects, which could be mild, moderate, or serious. Your clinical team will monitor you very closely and treat any problems quickly. Joining the trial is entirely your choice, and you can change your mind and leave at any time without your regular NHS care being affected.

Locations (15)

Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland
UCLH
Approximate
London, England
Western General Hospital
Approximate
Edinburgh, Scotland
Aberdeen Royal Infirmary
Approximate
Aberdeen, Scotland
Guys Hospital
City only
London, England
Ninewells Hospital
Unverified
Dundee, Scotland
St James's University Hospital
Unverified
Leeds, England
Churchill Hospital
Unverified
Oxford, England
Royal Free Hospital
Unverified
London, England
Clatterbridge Cancer Centre
Unverified
Liverpool, England
Northern Ireland Cancer Centre
Unverified
Belfast, Northern Ireland
Velindre Cancer Centre
Unverified
Cardiff, Wales

Common questions

What is ginisortamab and how does it work?

Ginisortamab is an experimental drug designed to block a protein called gremlin-1. Blocking this protein helps turn natural tumour-fighting signals back on, potentially making cancer cells more vulnerable to chemotherapy.

Do I have to pay to take part in this trial?

No. The trial medication and all extra study-related tests are provided free of charge, usually through NHS hospital research departments funded by Cancer Research UK.

Will I definitely receive the new drug?

If you join Module 1, you will receive ginisortamab with chemotherapy. If you join the larger second stage of Module 2, a computer will randomly choose whether you receive the study medicines or routine observation.

What are tumour biopsies and why are they needed?

A biopsy involves taking a tiny piece of tissue from your tumour using a small needle. Researchers examine these cells under a microscope to see whether the drug is reaching the cancer and working as intended.

Can I leave the study if I change my mind?

Yes. You are free to withdraw from the trial at any point, for any reason. Your medical team will continue to offer you the best standard care available.

How to find out more

Josephine Salimu

Josephine.Salimu@cancer.org.uk +44 (0)2034698135 Official trial record

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