Active not recruitingPHASE1INTERVENTIONAL

A CR-UK Phase I Trial of LY3143921

This study is investigating a new drug called LY3143921 hydrate for adults with several types of advanced solid cancers, including bowel, ovarian, lung, oesophageal, head and neck, bladder, breast, and pancreatic cancer. This drug works by targeting a protein called Cdc7, which is often found at higher levels in cancer cells and helps them grow and multiply. By blocking Cdc7, the drug aims to stop cancer cells from replicating and ultimately cause them to die. The study has two parts: the first part, which is now complete, aimed to find a safe dose. The second part, which is ongoing, is looking at a larger group of patients at the safe dose to understand more about how effectively the drug works against these cancers and to monitor any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Cancer Research UK

Enrolment target

Start

21 Jun 2017

Estimated completion

28 Feb 2027

A. Colorectal Cancer B. High Grade Serous Ovarian Cancer C. Non Small-cell Lung Cancer (squamous Cell Variant)D. Squamous Carcinoma of the Oesophagus E. Squamous Carcinoma of the Head and Neck (HPV Negative)F. Urothelial Cancer G. Breast Cancer (triple Negative Type)H. Pancreatic Cancer

What is this study about?

This study is looking at a new medicine called LY3143921 hydrate. It's being tested in adults who have certain types of cancers that are advanced, meaning they've spread or haven't responded to usual treatments. The main goal of this study is to find out the safest dose of this new drug, what side effects it might cause, and how to manage them. We also want to understand if the drug is effective in treating these cancers.

The drug, LY3143921 hydrate, works by targeting a protein called Cdc7. In healthy cells, Cdc7 is usually found at low levels, but in many cancer cells, especially in the types of solid cancers included in this study, Cdc7 levels can be much higher. This protein helps cancer cells to grow and multiply rapidly. By blocking Cdc7, the drug aims to stop these cancer cells from copying themselves and spreading, which could lead to them dying off. Early laboratory and animal studies have shown promising results.

This study has been divided into two main parts. The first part, called 'dose escalation,' has already finished. In this part, different groups of patients received increasing doses of the drug to work out a safe level and a dose that best tackles the cancer cells. The second part, known as the 'expansion' phase, is now underway. In this phase, a larger group of patients will receive the dose found to be safest and most effective in the first part. This will help us gather more information about how the drug works and any effects it has.

Key takeaways

This study is testing a new drug for advanced solid cancers.
The drug aims to stop cancer cell growth by targeting the Cdc7 protein.
The study focuses on finding a safe dose and understanding the drug's effects.
It covers several types of advanced cancers, including bowel, ovarian, and lung.
Participation involves regular checks and medical assessments.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you must have an advanced solid cancer that has either not responded to standard treatments, or for which there are no standard treatments available, or you have chosen not to have them. The types of cancer being studied specifically include bowel cancer, a type of ovarian cancer (high-grade serous), a type of lung cancer (squamous cell), squamous cancers of the food pipe (oesophagus) and head and neck (if not linked to HPV), bladder cancer, a type of breast cancer (triple negative), and pancreatic cancer.

You should also be able to carry out daily activities with little or no difficulty (known as a WHO performance status of 0 or 1), and doctors expect you to live for at least 12 more weeks. You must be at least 18 years old. Before joining, you'll need to give your informed consent, which means you'll receive all the information about the study and agree to take part after understanding it fully.

There are also some medical checks needed to ensure you are well enough. This includes having blood test results within specific ranges for your blood count, kidney, and liver function. These tests ensure your body can safely handle the study drug. For some patients, we might ask for a small sample of your tumour tissue before and after treatment to understand how the drug is working. If you're able to provide this, it would be very helpful.

Quick self-check

Are you 18 years old or older?
Do you have one of the specified advanced solid cancers?
Has your cancer not responded to usual treatments, or are there no standard treatments available?
Can you carry out most daily activities without much difficulty?
Are your recent blood tests (for blood count, liver, and kidney function) within the normal ranges specified by the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be taking a new drug called LY3143921 hydrate. The study is divided into different periods, during which you'll have regular visits to the hospital or clinic. These visits will involve various tests and assessments to monitor your health, check for side effects, and see how the drug is affecting your cancer. These could include blood tests, health checks, and scans.

You'll receive the study drug for as long as it's helping you and you're not having serious side effects. The frequency of your visits might be more intensive at the beginning of the treatment and then become less frequent over time. The total duration you'll be involved in the study will depend on how you respond to the treatment and your individual circumstances. After you stop taking the drug, there will be some follow-up visits to ensure your well-being. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as you would be among the first to try a new drug that has shown promise in laboratory and animal studies. While there's no guarantee, the drug might help to slow down or shrink your cancer. However, as with any new medicine, there are potential risks and side effects. These could include unexpected reactions, or known side effects that need to be carefully monitored and managed by the study team. You'll receive comprehensive information about all known and potential risks before you decide to join. It's very important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Cancer Centre, Belfast City Hospital
Belfast, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom

Common questions

What is LY3143921 hydrate?

It's a new drug being tested in this study that aims to stop cancer cells from growing and multiplying by targeting a protein called Cdc7.

What types of cancer is this study for?

It's for several types of advanced solid cancers, including bowel, ovarian, lung, oesophageal, head and neck, bladder, breast (triple negative), and pancreatic cancers.

What is the main goal of the study?

The main goals are to find a safe dose of the new drug, understand its side effects, and see how well it works against these cancers.

Will I have to have biopsies?

For some patients, providing small tumour and skin samples before and after treatment is helpful for the study, but for most, it's optional.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without affecting your other medical care.