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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

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
Howwkrww Vbpb digzjfzf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	16.02.2022

Trial locations

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.

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 ID:

2024-516290-67-00

Protocol code:

CYC140-101

NCT ID:

NCT03884829

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?