A Phase II trial of ginisortamab in participants with metastatic pancreatic ductal adenocarcinoma
Research type
Research Study
Full title
A Cancer Research UK Phase II open label trial in participants with metastatic pancreatic ductal adenocarcinoma of ginisortamab given intravenously i) with first-line standard of care nab-paclitaxel and gemcitabine, or ii) in combination with MEK inhibitor maintenance therapy.
IRAS ID
1007925
Contact name
Rashida Teladia
Contact email
Sponsor organisation
Cancer Research UK
ISRCTN Number
ISRCTN63154609
Research summary
We are testing a drug called ginisortamab that blocks a protein called gremlin-1. Gremlin-1 is mainly found outside cancer cells and 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 will allow BMP protein function, and we hope this will change the way the cancer cells develop, making them more sensitive to chemotherapy.
We are testing ginisortamab in pancreatic ductal adenocarcinoma (PDAC) that has spread (metastatic) in 2 settings (modules). 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 who have responded (response or stable disease) to a first-line standard of care regimen (FOLFIRINOX or nab paclitaxel plus gemcitabine) after ≥16 weeks.
The four main aims of this clinical trial are to find out:
1. The best dose that can be given safely 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
Both modules will consist of a safety run-in, followed by an expansion cohort at the best dose from the safety run-in. We aim to recruit between 6 and 36 participants in the safety run-in and then up to 60 participants in the expansion cohort for each module. Module 2 participants in the expansion cohort will be randomised (randomly allocated) to either i) maintenance therapy of ginisortamab in combination with a MEK inhibitor or ii) observation only.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0662
Date of REC Opinion
4 Jan 2024
REC opinion
Further Information Favourable Opinion