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Study of Fadraciclib in Adults with Advanced Solid Tumors (Including Breast, Colorectal, Endometrial, Ovarian, Biliary Tract, and Liver Cancer) 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 clinical trial studies the effects of fadraciclib (also known as CYC065) in people with various types of advanced cancers. The study focuses on several types of solid tumors and lymphoma, including endometrial cancer, ovarian cancer, biliary tract cancer, hepatocellular carcinoma, B-cell lymphoma, T-cell lymphoma, metastatic colorectal cancer, and different types of breast cancer.

The medication being tested, fadraciclib, is taken by mouth in tablet form. It belongs to a group of drugs called CDK2/9 inhibitors, which work by blocking certain proteins that help cancer cells grow. The study aims to find the best dose of the medication and determine how well it works in treating these different types of cancer.

During the study, participants take the medication either once or twice daily in 28-day cycles. The treatment continues as long as it is helping and the side effects are manageable. Throughout the study, doctors monitor the participants' health and how their cancer responds to the treatment. This includes regular check-ups and various medical tests to ensure safety and track the effectiveness of the medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive fadraciclib in tablet form. The medication needs to be taken orally either once or twice daily, depending on your assigned schedule.

    Each treatment cycle lasts 28 days.

    It is essential to be able to swallow and keep down the tablets. You should not have any significant digestive system conditions that could affect drug absorption.

  2. Step 2

    Treatment monitoring

    Regular laboratory tests will be conducted to monitor your health status throughout the study.

    Your response to treatment will be evaluated using specialized imaging and assessment criteria appropriate for your type of cancer.

    The medical team will monitor any side effects that may occur during the treatment.

  3. Step 3

    Ongoing assessments

    Your cancer's response to treatment will be regularly evaluated using standard medical criteria (RECIST for solid tumors, Lugano Criteria for lymphoma, or mSWAT for skin lymphoma).

    The medical team will track how long the treatment remains effective.

    Your overall health status and survival will be monitored throughout the study period.

  4. Step 4

    Study duration

    The study is scheduled to continue until October 30, 2025.

    During the entire study period, you must use effective birth control methods if pregnancy is possible (continuing for 6 months after the last dose).

    Regular attendance at scheduled appointments is required to maintain participation in the study.

Who can join the trial?

13 criteria

  • Age 18 years or older
  • Must have confirmed advanced cancer that has either:
    • Progressed despite standard treatment, or
    • Cannot tolerate standard treatment, or
    • No standard treatment exists
    • Must have an ECOG performance status of 0 or 1 (able to carry out all normal activities with minimal restrictions)
    • Laboratory test results must meet specific requirements defined in the study protocol
    • 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 the last dose
      • For men who can father children:
        • Must use effective birth control during the study and for 6 months after the last dose
        • Must be able to:
          • Swallow and keep down oral medication
          • Not have any significant digestive system problems that could affect drug absorption
          • Must be willing and able to:
            • Sign the informed consent form
            • Follow all study requirements

Who cannot join the trial?

14 criteria

  • Prior treatment with CDK inhibitors (drugs that block cell growth) within 14 days before starting the study
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression requiring treatment
  • Major surgery within 4 weeks before starting the study
  • Serious heart conditions, including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within the past 6 months
    • Abnormal heart rhythm requiring medication
    • Active, uncontrolled infections requiring treatment
    • Known HIV infection or active hepatitis B or C
    • Other active cancers requiring treatment (except non-melanoma skin cancer or cervical cancer in situ)
    • Pregnant or breastfeeding women
    • Serious medical conditions that could interfere with study participation
    • Unable to swallow oral medications
    • Known allergies to the study medication or its components
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Investigated drugs

Fadraciclib (CYC065) is an oral medication that works by inhibiting specific proteins called CDK2 and CDK9, which are involved in cell division and growth. This medication is being studied as a potential treatment for advanced solid tumors and lymphoma. It is taken by mouth either once or twice daily. Fadraciclib is designed to help patients whose cancer has either returned after previous treatments or has not responded to standard therapies.

What is already known about the treatment

Fadraciclib (CYC065) - An oral medication administered in tablet form, taken either once or twice daily, that functions as a CDK2/9 inhibitor (cyclin-dependent kinase inhibitor) currently being investigated in clinical trials for various advanced cancers. This experimental drug works by blocking specific proteins involved in cell division and growth, potentially stopping or slowing the progression of cancer cells in multiple tumor types including endometrial, ovarian, breast, and liver cancers, as well as lymphomas. The medication is being studied to determine its safety, effectiveness, and optimal dosing in patients who have exhausted standard treatment options or for whom no standard therapy exists.

Investigated diseases

  • Endometrial cancer

    A cancer that develops in the lining of the uterus (endometrium). It typically begins when cells in the endometrium start growing abnormally and multiply rapidly.

  • Ovarian cancer

    A disease where abnormal cells develop in the ovaries. The cancer can form in different types of cells within the ovary and may spread to other parts of the body.

  • Biliary tract cancer

    A cancer that develops in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine. The disease affects the cells lining these ducts.

  • Hepatocellular carcinoma

    The most common type of primary liver cancer that begins in the main type of liver cells (hepatocytes). It develops when liver cells begin to grow abnormally.

  • B-cell lymphoma

    A cancer that develops from B lymphocytes, which are white blood cells that help fight infection. These abnormal B-cells multiply in lymph nodes and other tissues.

  • T-cell lymphoma

    A cancer that develops from T lymphocytes, another type of white blood cells. The abnormal T-cells can accumulate in the skin, lymph nodes, or other organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516289-12-00Protocol codeCYC065-101Estimated enrolment354 patientsSponsorCyclacel Limited

sourced from the EU Clinical Trials Register and site verification

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