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A phase 2 trial looking at a new drug FP-1305 to treat advanced cancers.
Research title: A Phase I/II open–label, three-part, dose-finding and separate cohort expansion trial to assess the safety, tolerability and preliminary efficacy of repeated doses of CLEVER-1 antibody FP-1305, in advanced solid tumours (MATINS).
Why is this trial being carried out?
The MATINS trial wants to see if a new drug called FP-1305 can be used to treat advanced cancer. This is the first time that FP-1305 has been tested in humans.
Advanced cancer is cancer that has spread to other parts of the body. People with advanced pancreatic cancer aren’t able to have surgery to remove the cancer, and some people may need to have chemotherapy. This trial will look at several different types of advanced cancer, including advanced pancreatic cancer.
FP-1305 is a new drug. It works by helping the body’s immune system to recognise and destroy cancer cells. The MATINS trial will look at whether FP-1305 is effective at treating advanced cancer. It will also look at the dose of FP-1305 that works best against cancer while remaining safe.
Who is the trial suitable for?
The MATINS trial may be suitable for you if you:
- have advanced pancreatic cancer
- have advanced liver cancer (hepatocellular carcinoma), gallbladder cancer, advanced bile duct cancer (cholangiocarcinoma), advanced bowel (colorectal) cancer, advanced ovarian cancer, advanced cutaneous or uveal melanoma (skin cancer), gastric adenocarcinoma or estrogen receptor (ER) positive breast cancer
- have had other standard treatments which haven’t worked
- you are well enough to take part in this trial – you will have tests to check this.
The MATINS trial may not suitable for you if:
- it is less than three weeks since your last dose of chemotherapy
- you have had immunotherapy less than 6 weeks ago
- you have had major surgery in the last month
- you have had a serious infection in the 2 weeks before starting the trial
- your cancer has spread to your brain
- you have a serious medical condition, including heart failure, an auto-immune disorder, HIV, or you are having kidney dialysis – your doctor will be able to tell you more about this
- you take steroids, or another type of treatment that suppresses your immune system
- you have had an organ transplant.
There may be other reasons for not being able to take part in this trial. It is important to speak to your doctor about whether this trial might be suitable for you.
What does the trial involve?
Before taking part in the MATINS trial, you will need to have some tests to check that you are able to take part. These are known as screening tests.
Screening tests include blood tests and a CT or MRI scan. You will need to have a sample of the cancer taken (a biopsy), but if you have had a biopsy in the last 6 months you won’t need to have another one. The doctor will also ask you questions about your health and the medicines you are taking.
You will also have tests during and after the trial. This is to see how the drug FP-1305 is working, and if it has an effect on the cancer and your immune system.
FP-1305 is given once every three weeks. It is given directly into a vein by intravenous infusion – you may hear this being called a ‘drip’. The drip will take one to two hours.
The trial will last for up to one year. If FP-1305 is helping you, you can have this treatment for longer – your doctor or nurse can tell you more about this.
The first time you have this treatment you will need to stay in hospital so that a nurse can monitor you – your doctor will be able to tell you more about this.
You will need to have tests at the hospital in between your treatment sessions. This is to see how the drug is working. Your doctor can tell you how often you will have these tests.
Recruitment start date: December 2018
Recruitment end date: August 2022
Published: December 2019
Review date: December 2021