Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF CYC140, AN ORAL PLK1 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA

This research is testing a new oral drug called CYC140 for individuals diagnosed with advanced solid tumours or lymphoma. It’s an early-stage trial, divided into two main parts. In the first part (Phase 1), the aim is to find the safest dose of the new drug by gradually increasing it and watching closely for any side effects. In the second part (Phase 2), once a safe dose is found, the study will look at how well the drug works. This means checking if it can shrink tumours or stop them from growing, using specific medical guidelines to measure its effects. Researchers will also observe how the drug affects the body and how patients feel throughout the study. Participants must be 18 or older.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Cyclacel Limited

Enrolment target

Start

13 Aug 2024

ADVANCED SOLID TUMORS AND LYMPHOMA

What is this study about?

This study is looking at a new medicine called CYC140, which is taken by mouth. It's designed to treat advanced solid tumours and lymphoma. "Advanced" means the cancer has grown or spread. This is an early stage clinical trial, meaning it's one of the first times this drug is being tested in people, so we're still learning a lot about it. The main goals are to understand if it's safe, how the body handles the drug, and if it can help patients with these types of cancer.

The study has two main parts. The first part, called Phase 1, focuses on safety. A small group of volunteers will start with a low dose of CYC140, and if it's tolerated well, the dose will be slowly increased for other groups. This helps researchers find the highest dose that can be given safely without too many serious side effects. They'll be carefully monitoring for any unwanted reactions, especially in the first few weeks of treatment.

Once a safe dose is found, the study moves into Phase 2. In this phase, more patients will receive the drug at the safe dose. Here, the focus shifts to whether the drug actually works. Researchers will be looking for signs that the tumours are shrinking or that their growth has stopped. This is measured using standard medical imaging and tests, depending on the type of cancer. They'll also continue to track side effects and how patients are generally feeling.

Key takeaways

Tests new oral medicine (CYC140) for advanced solid tumours and lymphoma.
Aims to find safest dose and see if it shrinks tumours or stops growth.
Includes regular clinic visits, blood tests, and scans.
Participation is voluntary, you can leave at any time.
Potential benefits include access to a new treatment, but risks like side effects exist.

Who may be eligible?

To be able to take part in this study, you generally need to be at least 18 years old. There's no upper age limit mentioned, so older adults might also be able to join. Both men and women are welcome to participate.

Since this study is for advanced solid tumours and lymphoma, you would need to have one of these diagnoses. The doctors running the study will have specific criteria about the exact stage of your cancer and any previous treatments you might have had to determine if this study is right for you.

It's important to remember that even if you meet these general criteria, there might be other medical details or health conditions that could prevent you from taking part. The study doctors will carefully check all your medical information to see if you are a good fit and if it's safe for you to participate.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with an advanced solid tumour or lymphoma?
Are you able to take medicines by mouth?
Are you willing to attend regular hospital visits for tests and check-ups?

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

What does participation involve?

If you decide to take part in this study, you'll be taking a new medicine called CYC140 by mouth. Initially, during the first part of the study (Phase 1), you'll start at a specific dose, and doctors will carefully watch for any side effects, especially in the first month.

Throughout the study, you'll have regular visits to the clinic. These visits will involve various assessments, such as blood tests, physical examinations, and scans (like CT or MRI scans, depending on your cancer type) to check on your health and see how the medicine is affecting your tumour. For lymphoma patients, specific evaluations called Lugano Criteria will be used, and for a type of skin lymphoma (CTCL), a measure called mSWAT will be used, to track changes in your condition.

The study will also track how long the medicine helps keep your cancer from growing or spreading (this is called progression-free survival), and how long you respond to the treatment. They will also look at how long people live after starting the treatment (overall survival). There will also be some exploratory tests, such as looking at your blood for changes at a genetic level. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will have follow-up visits even after you stop taking the study drug.

Potential risks and benefits

Participating in a clinical trial like this means you might be among the first to receive a new medicine, which could potentially help your condition if current treatments haven't worked well. While there's a chance the drug could shrink your tumour or slow its growth, it's also possible it may not help you, or it may cause side effects. Like all medicines, CYC140 could have unwanted reactions, ranging from mild to serious. These will be carefully monitored throughout the study. You will be given full information about the known and potential risks before you decide to join. Remember, taking part is completely 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 (1)

—
Spain

Common questions

What is CYC140 and how is it given?

CYC140 is a new medicine being tested; it's taken by mouth as a tablet or capsule.

What types of cancer is this study for?

This study is for people with advanced solid tumours and lymphoma.

What do 'Phase 1' and 'Phase 2' mean in this study?

Phase 1 is about finding the safest dose of the new medicine. Phase 2 then checks how well that safe dose works against cancer.

Will I definitely receive the new drug?

Yes, in this open-label study, all participants will receive the active drug CYC140. There isn't a placebo group.

What happens if the drug doesn't work for me?

Your doctors will regularly check how you're responding. If the drug isn't helping or if side effects are too severe, your study doctor will discuss other treatment options with you.