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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mrs
Sarah
Potter
+44 (0)203 469 8957
Sarah.Potter@cancer.org.uk
Prof
Jeff
Evans
+44 (0)141 330 ext 4171
jeff.evans@beatson.gla.ac.uk
Miss
Rashida
Teladia
+44 (0)203 469 6878
Rashida.Teladia@cancer.org.uk
Metastatic pancreatic ductal adenocarcinoma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
In this study the researchers are testing a drug called ginisortamab that blocks a protein called gremlin-1. Gremlin-1 is mainly found outside cancer cells and it stops the function of other proteins called bone morphogenetic proteins (BMPs). BMP proteins work by suppressing cancer cells as they occur but in cancer this mechanism has often been switched off. Blocking gremlin-1 with ginisortamab is expected to allow BMP protein function, and we hope this will change the way the cancer cells develop, making them more sensitive to other targeted treatments and/or chemotherapy.
The researchers are testing ginisortamab in two different settings (modules), in people with pancreatic ductal adenocarcinoma (PDAC) that has spread (metastatic). Module 1 will involve participants about to start first-line therapy of ginisortamab with standard-of-care chemotherapy, nab-paclitaxel and gemcitabine. Module 2 will involve participants whose tumours have either shrunk or not grown significantly with a first-line standard of care regimen (FOLFIRINOX [folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin], or nab-paclitaxel plus gemcitabine) after ≥16 weeks of treatment who will then be randomised to either i) maintenance therapy of ginisortamab in combination with another treatment called a MEK inhibitor (which can help stop cancer cells from growing and may kill them by blocking two proteins called MEK1 and MEK2) or ii) observation only.
The four main aims of this clinical trial are to find out:
1. The best dose of ginisortamab to be given to participants along with nab-paclitaxel and gemcitabine (Module 1) or a MEK inhibitor (Module 2).
2. More about potential side effects of ginisortamab when given with nab-paclitaxel and gemcitabine (Module 1) or a MEK inhibitor (Module 2) and how they can be managed.
3. To see if adding ginisortamab to treatment improves the effectiveness of treatment.
4. What happens to ginisortamab inside the body and what effect it has on tumour samples.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Module 1 exclusion criteria:1. Previous radiotherapy (except palliative) within 6 months prior, chemotherapy, investigational therapy for metastatic PDAC, other anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of IMP.2. Live vaccinations will not be permitted within 28 days before trial enrolment.3. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.4. Prior neo-adjuvant, peri-operative, or adjuvant chemotherapy for non-metastatic pancreatic adenocarcinoma with curative intent unless recurrent (i.e. metastatic) disease is documented more than 6 months since the last dose of systemic therapy. 5. Clinically significant/symptomatic third space fluid accumulation (e.g. ascites or pleural effusion).6. Ongoing toxic manifestations of previous treatments considered by the Investigator to make the patient unsuitable for the trial. 7. Brain or leptomeningeal metastases.8. Clinically significant ongoing pulmonary disease, including but not limited to interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis.9. History of pulmonary embolism or deep vein thrombosis unless continuing anticoagulant treatment as clinically indicated.10. Female patients of childbearing potential. However, those patients of childbearing potential who are not already pregnant or breastfeeding, or who agree to discontinue breastfeeding, or who meet the following points are considered eligible:11. Have a negative highly sensitive serum pregnancy test within 7 days before Day 1 and either:11.1. Agree to one form of highly effective contraception11.2. Or agree to sexual abstinenceEffective from the date of the negative pregnancy test, throughout the trial and for 6 months after the last administration of IMP or SoC chemotherapy agents (whichever component is administered last).11.3. Male patients with partners of childbearing potential or who are pregnant or breastfeeding. However, those patients who meet the following points are considered eligible: 11.3.1. Agree to take measures not to father children by using a barrier method of contraception (condom) or sexual abstinence effective from the date of the first administration of IMP and SoC chemotherapy agents, throughout the trial and for 6 months after the last administration of IMP or SoC chemotherapy agents (whichever component is administered last).11.3.2. Non-vasectomised male patients must also be willing to ensure that any partner who is of childbearing potential uses a highly effective method of contraception or agrees to sexual abstinence for the same duration.11.3.3. Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent exposure of the foetus or neonate.12. Major thoracic or abdominal surgery from which the patient has not yet recovered.13. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.14. Known hypersensitivity to any of the ingredients/excipients in the IMP to be administered.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Jeff
Evans
+44 (0)141 330 ext 4171
jeff.evans@beatson.gla.ac.uk
Miss
Rashida
Teladia
+44 (0)203 469 6878
Rashida.Teladia@cancer.org.uk
Mrs
Sarah
Potter
+44 (0)203 469 8957
Sarah.Potter@cancer.org.uk
The study is sponsored by Cancer Research UK and funded by Cancer Research UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
