CompletedPhase IInterventional

A Phase I trial of LY3143921 hydrate in solid tumours

This clinical trial is studying a new drug called LY3143921 hydrate for adults with advanced solid cancers like bowel cancer, ovarian cancer, and lung cancer. These are cancers where current treatments are no longer working, aren't suitable, or the patient has decided not to have them. The drug works by targeting a protein called Cdc7, which is often found in higher amounts in cancer cells and helps them grow. The main goals are to find out the safest and most effective dose of this new drug, to see what side effects it might have, and to understand how it affects cancer cells. This is an early-stage study, meaning it’s the first time this drug is being tested in people.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Centre for Drug Research and Development

Enrolment target

115

Start

28 Jun 2017

Estimated completion

24 Nov 2021

Colorectal Cancer (CRC), High Grade Serous Ovarian Cancer (HGSOC), Non-Small Cell Lung Cancer (NSCLC; Squamous Cell Variant), Squamous Carcinoma of the Oesophagus, Squamous Carcinoma of the Head and Neck (Human Papillomavirus Negative), Urothelial Cancer, Breast Cancer (Triple Negative Type), Pancreatic Cancer

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first times a new drug, called LY3143921 hydrate, is being tested in people. The main purpose of this early stage is to check if the drug is safe, what side effects it might cause, and to find the highest dose people can take without serious problems. It also aims to see how the drug moves through the body and if it has any effect on cancer.

The drug works by targeting a protein called Cdc7. In healthy cells, Cdc7 is usually found at low levels, but in many types of cancer cells, including those this study is focusing on, it can be much higher. Cdc7 helps cancer cells to copy themselves and grow. Researchers believe that LY3143921 hydrate could block Cdc7, stopping cancer cells from growing and causing them to die. This trial is looking at various solid cancers, such as certain types of bowel, ovarian, and lung cancer.

This trial is important because it could lead to a new way to treat these cancers, especially for patients whose current treatments aren't working or who can't have them. While there's no guarantee the drug will help people directly in this early stage, the information gathered will be vital for developing better cancer treatments in the future.

Key takeaways

This is an early-stage study (Phase I) for a new cancer drug.
It targets advanced solid cancers when other treatments are no longer an option.
The drug aims to stop cancer cell growth by blocking a protein called Cdc7.
The main goals are to find a safe dose and understand potential side effects.
Potential benefits include direct help for your cancer or improved future treatments.
Possible side effects include dizziness and eyesight changes.

Who may be eligible?

This study is for adults aged 18 and over who have advanced solid cancers. This means your cancer has spread, or it can't be cured with current treatments.

You might be able to join if your current cancer treatment is no longer working, if there are no other suitable treatments available for your type of cancer, or if you've decided not to have the treatments you've been offered.

There are also some general health requirements to make sure it's safe for you to take part. For example, your body needs to be strong enough to manage the treatment, and your blood test results should be within a certain range.

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 18 years old or older.
I have an advanced solid cancer.
My current cancer treatment isn't working, or there are no other suitable treatments, or I've decided not to have them.
My general health is good enough to take part.
I am able to visit the study site regularly for appointments.

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study happens in two parts. In the first part, called 'dose escalation,' small groups of patients will start with a very low dose of the new drug, LY3143921 hydrate. Doctors will carefully check your vital signs (like heart rate and blood pressure) and blood tests, and if there are no major problems, the next group of patients will receive a slightly higher dose. This continues until doctors find the safest dose that also works best against cancer cells.

Once a safe dose is found, the second part, called 'expansion,' will involve a larger group of patients receiving that dose. This helps doctors learn more about how the drug works and which specific cancers might benefit most. Throughout the study, you'll have regular hospital visits for blood tests to see how your body is handling the drug and how quickly it's removed from your system. Some patients might also have small tissue samples (biopsies) taken from their cancer before and during treatment to help researchers understand the drug better. The study is expected to run until April 2025.

Potential risks and benefits

As this is the first time this drug is being used in humans, the direct benefits are not yet known. However, there's a chance the drug might help to treat your cancer. Even if it doesn't directly help you, the information gathered from this study will be very important for developing new cancer treatments for others in the future. Like all medications, there's a risk of side effects. Some possible side effects include feeling dizzy or lightheaded due to low blood pressure, or eye pain and changes to your eyesight. Your safety will be closely monitored, 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)

Western General Hospital
Approximate
Edinburgh, Scotland
Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland
Northern Centre for Cancer Care
City only
Newcastle Upon Tyne, England
Cancer Centre
Approximate
Belfast, Northern Ireland

Common questions

What is a 'Phase I' trial?

It's the very first stage of testing a new drug in people. The main goals are to check if it's safe, find the right dose, and look for possible side effects.

What does LY3143921 hydrate do?

It's a new drug designed to block a protein called Cdc7, which helps cancer cells grow. By blocking it, the drug aims to stop cancer cells from multiplying and cause them to die.

What types of cancer is this study for?

It's for advanced solid cancers like certain types of bowel, ovarian, lung, oesophageal, head and neck, bladder, breast, and pancreatic cancer, where other treatments haven't worked or aren't an option.

Will I get the new drug?

Yes, all participants in this trial will receive the study drug, LY3143921 hydrate, at either an increasing dose for the first part, or at the chosen safe dose for the second part.

Who is running and paying for this study?

The study is run by the Cancer Research UK Centre for Drug Development, and Cancer Research UK is also funding it.

How to find out more

Hayley Cartwright

drugdev@cancer.org.uk +44 (0)300 123 1022 Official trial record

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