Study of Fadraciclib in Adults with Advanced Solid Tumors (Including Breast, Colorectal, Endometrial, Ovarian, Biliary Tract, and Liver Cancer) and Lymphoma

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hlinnwda Vehd dlkdrtbx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	30.06.2021

Trial locations

Investigated drugs:

Fadraciclib

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.

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.

Metastatic colorectal cancer – Cancer that originates in the colon or rectum and has spread to other parts of the body. It begins in the cells lining the large intestine.

Breast cancer – A disease where cells in the breast tissue grow out of control. Different types exist based on the presence or absence of specific receptors (HER-2, hormone receptors) on the cancer cells.

Trial ID:

2024-516289-12-00

Protocol code:

CYC065-101

Trial Phase:

Human Pharmacology (Phase I) – Other

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?