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Study of CYC140 oral medication for patients with advanced solid tumors and lymphoma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with advanced solid tumors and lymphoma. The research evaluates a new medication called CYC140, which is taken by mouth in the form of hard capsules. This drug works as a PLK1 inhibitor, which is a substance that blocks a specific protein involved in cancer cell growth.

The purpose of this research is to determine how safe the medication is, how it moves through the body, and how effective it is in treating these types of cancer. The study is divided into two parts. In the first part, different doses of the medication will be tested to find the most appropriate amount. In the second part, researchers will evaluate how well the medication works in treating the cancer.

During the study, participants will take CYC140 once daily for 28-day cycles. The treatment will continue as long as it remains beneficial for the patient. Throughout the study, doctors will monitor patients' health status and how their cancer responds to the treatment. Various medical assessments will be performed to track the progress of the treatment and ensure patient safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on your medical history and current health status

    You must be at least 18 years old and have confirmed advanced cancer that has progressed despite standard treatment

    Your physical condition will be assessed using the ECOG performance scale (a measure of daily living abilities)

    A pregnancy test is required for women who can become pregnant, to be conducted within 7 days before starting treatment

  2. Step 2

    Treatment cycles

    You will receive CYC140, an oral medication in capsule form

    The medication needs to be taken once daily

    Each treatment cycle lasts 28 days

    You must be able to swallow capsules and not have any digestive system conditions that could affect drug absorption

  3. Step 3

    Monitoring during treatment

    Regular assessments will track how your cancer responds to treatment

    Your health will be monitored for any side effects

    Imaging scans will be performed to measure tumor response

    Blood samples will be collected to study how the medication works in your body

  4. Step 4

    Safety measures

    Both male and female participants must use effective birth control during the study and for 6 months after the last dose

    Any side effects will be evaluated using standard medical criteria

    Regular health assessments will continue throughout the treatment period

  5. Step 5

    Study duration

    The study is scheduled to continue until November 2025

    Your participation duration will depend on how your body responds to the treatment and any side effects that may occur

Who can join the trial?

11 criteria

  • Must be at least 18 years old
  • Must have confirmed advanced cancer that has either: - Gotten worse after standard treatment - Been unable to tolerate standard treatment - Has no standard treatment options available
  • Must have a documented worsening of cancer on imaging scans from their last treatment
  • Must have at least one tumor that can be measured on scans
  • Must have an ECOG performance status of 0-2 (a measure of daily living abilities, where 0 means fully active and 2 means able to do light activities but resting less than half the day)
  • If previously had a stem cell transplant, must not have active fungal infection or significant graft-versus-host disease (when transplanted cells attack the body)
  • For women who can become pregnant: - Must have a negative pregnancy test within 7 days before starting treatment - Must use effective birth control during the study and for 6 months after
  • For men who can father children: - Must use effective birth control during the study and for 6 months after
  • Must be able to swallow and keep down oral medications
  • Must not have digestive system conditions that could affect how the medication is absorbed
  • Must be able to understand and sign the consent form and follow study requirements

Who cannot join the trial?

15 criteria

  • Prior treatment with CYC140 (the study medication)
  • Active brain metastases (cancer that has spread to the brain) or brain involvement that is not stable
  • Ongoing significant side effects from previous cancer treatments
  • Severe heart conditions including heart failure, unstable heart rhythm, or recent heart attack (within 6 months)
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study
  • Active, uncontrolled infections requiring treatment
  • Known positive test for HIV, hepatitis B, or hepatitis C
  • Pregnant or breastfeeding women
  • Inability to swallow oral medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Participation in another clinical trial within 4 weeks before starting this study
  • Life expectancy less than 3 months
  • Significant kidney or liver problems
  • Known allergic reactions to similar medications
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Investigated drugs

CYC140 is an oral medication that works as a PLK1 inhibitor. It is being studied for treating advanced solid tumors and lymphoma. This medication is taken by mouth once daily and works by blocking a specific protein (PLK1) that is involved in cell division. It is designed to help patients whose cancer has not responded to standard treatments or for whom no standard treatment options are available.

What is already known about the treatment

CYC140 - An oral PLK1 (Polo-like kinase 1) inhibitor administered once daily in 28-day cycles for treating advanced solid tumors and lymphoma. This investigational drug works by blocking PLK1, a protein kinase that plays a crucial role in cell division and tumor growth, making it a potential targeted therapy for cancer treatment. Currently undergoing Phase 1/2 clinical trials, CYC140 is being studied in patients who have exhausted standard treatment options or for whom no standard therapy exists, with the primary goals of determining optimal dosing and evaluating its effectiveness in treating various types of advanced cancers.

Investigated diseases

  • Advanced Solid Tumors

    A condition where abnormal cells form solid masses or tumors in various body tissues and organs, spreading beyond their original location. The tumors can grow and invade nearby tissues and may spread to other parts of the body. These tumors can develop in different organs such as the lungs, breast, colon, or other body parts.

  • Lymphoma

    A type of blood cancer that develops in the lymphatic system, affecting lymphocytes (white blood cells). The disease causes lymph nodes to enlarge and can spread to other parts of the lymphatic system. Affected lymph nodes typically appear as painless lumps under the skin, most commonly in the neck, armpit, or groin. The condition can affect multiple parts of the body simultaneously as it develops within the lymphatic system network.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516290-67-00Protocol codeCYC140-101Estimated enrolment330 patientsSponsorCyclacel Limited

sourced from the EU Clinical Trials Register and site verification

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