Study of ECI830, ribociclib, and fulvestrant in patients with advanced hormone receptor positive, HER2-negative breast cancer and advanced solid tumors

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What is this study about?

This study is looking at patients with advanced solid tumors and patients with advanced HR-positive HER2-negative breast cancer. HR-positive means the cancer cells have receptors for hormones that help them grow, and HER2-negative means the cancer cells do not have too much of a certain protein called HER2. The study will test a medicine called ECI830, which will be given either alone or in combination with other treatments. The combinations being studied include ECI830 with ribociclib and fulvestrant, which are medicines used to treat breast cancer. Some patients may also receive hormone treatments such as goserelin or leuprorelin acetate, which help reduce the amount of hormones in the body that can make cancer grow. ECI830 is taken by mouth as a capsule, fulvestrant is given as an injection into the muscle, and ribociclib is taken by mouth as a tablet.

The purpose of this study is to find out if ECI830 is safe when given alone or with other treatments, to determine the right dose to use, and to see if the combination of ECI830 with ribociclib and fulvestrant can help stop the cancer from getting worse in patients with HR-positive HER2-negative breast cancer who have already received treatment with a type of medicine called a CDK4/6 inhibitor. The study will also look at how well these treatments work against the cancer by measuring things like whether tumors shrink or stop growing.

The study has two parts. The first part will test different doses of ECI830 to see what side effects occur and to find the best dose to use. The second part will give the chosen dose of ECI830 in combination with ribociclib and fulvestrant to a larger group of patients with breast cancer to see how well this combination works. During the study, patients will have regular check-ups where doctors will monitor their health, take blood samples, check heart activity, and use imaging scans to see how the cancer is responding to treatment. The study will track how long patients live without their cancer getting worse and how long they survive overall.

1 Treatment initiation and medication administration

The treatment will depend on which phase of the study applies to your situation. The study is divided into Phase I and Phase II.

In Phase I, you may receive ECI830 either alone or in combination with ribociclib and fulvestrant. ECI830 is given as a capsule taken by mouth. Ribociclib is also given as a capsule taken by mouth. Fulvestrant is given as an injection into the muscle.

In Phase II, you will receive ECI830 in combination with ribociclib and fulvestrant. The same methods of administration apply: ECI830 and ribociclib are taken by mouth, and fulvestrant is given as an injection into the muscle.

If your condition requires it, you may also receive hormone therapy with leuprorelin acetate or goserelin, both given as injections under the skin.

The specific doses and schedules will be determined based on safety and tolerability assessments during the study.

2 Regular monitoring and safety assessments

Throughout the study, your health will be monitored regularly to assess how the treatment is affecting you.

This includes checking for any side effects or adverse events, which are unwanted or harmful reactions to the medication.

Your doctor will perform laboratory tests to check your blood and organ function.

Vital signs such as blood pressure, heart rate, and temperature will be measured.

Electrocardiograms, also known as ECGs, will be performed to monitor your heart’s electrical activity.

These assessments help ensure your safety and determine if any adjustments to your treatment are needed.

3 Blood sample collection for medication level analysis

Blood samples will be collected at specific times during the study to measure the levels of ECI830 and ribociclib in your bloodstream.

This analysis helps determine how your body processes these medications, including measurements such as the area under the curve and maximum plasma concentration.

These measurements provide information about how much medication is in your blood over time and the highest level reached.

4 Tumor response evaluation

Your tumor will be evaluated regularly to see how it is responding to the treatment.

This evaluation will be done using RECIST v1.1, which stands for Response Evaluation Criteria in Solid Tumors, version 1.1. This is a standardized method for measuring changes in tumor size.

The assessments will determine outcomes such as overall response rate, which measures how many patients have their tumors shrink, best overall response, which is the best response your tumor shows during treatment, and disease control rate, which measures how many patients have their disease stabilized or improved.

For breast cancer patients without measurable tumors, bone lesions will be assessed if present.

In Phase II, a key evaluation will be the progression-free survival rate at 6 months, which measures the percentage of patients whose disease has not worsened after 6 months of treatment.

5 Dose adjustments if needed

If you experience significant side effects or certain safety concerns arise, your doctor may need to adjust your treatment.

This could include interrupting your medication temporarily, reducing the dose, or in some cases, discontinuing the treatment.

These adjustments are made to protect your health while trying to maintain the benefits of the treatment.

6 Ongoing treatment and follow-up

You will continue receiving the study treatment and undergoing regular assessments as long as the treatment is beneficial and you do not experience unacceptable side effects.

The duration of your participation will depend on how your disease responds to treatment and your overall tolerance of the medications.

Additional measurements during the study may include progression-free survival, which is the length of time you live without your disease getting worse, duration of response, which measures how long your tumor responds to treatment, and overall survival, which is the length of time you live from the start of treatment.

The study is expected to continue until approximately September 2028.

Who Can Join the Study?

You must be 18 years old or older
For Phase I, you must have one of the following: HR+/HER2- advanced breast cancer (which means breast cancer that has certain hormone receptors but does not have too much of a protein called HER2) that has gotten worse during or after at least one treatment with hormone therapy combined with a CDK4/6 inhibitor (a type of cancer drug that blocks proteins that help cancer cells grow) and at least one other type of treatment for cancer that has spread; OR a confirmed diagnosis of cancer that has spread or cannot be removed by surgery and has a CCNE1 amplification (extra copies of a specific gene). If you are joining the dose expansion part, you cannot have had more than 3 previous treatments for advanced or cancer that has spread
For Phase II, you must have HR+/HER2- advanced breast cancer that has gotten worse while taking an aromatase inhibitor (a hormone therapy drug) or tamoxifen (another hormone therapy drug) combined with a CDK4/6 inhibitor for cancer that cannot be removed by surgery or has spread, and you cannot have had more than 2 previous hormone therapy treatments
You must have cancer that can be measured using a specific method called RECIST v1.1 (a set of rules doctors use to measure tumors). For breast cancer only: if you do not have measurable cancer, you must have at least one bone lesion (an area where cancer has damaged the bone) that is mostly breaking down bone tissue, can be clearly measured at the start, and can be checked again during the study

Who Cannot Join the Study?

The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
Generally, clinical trials have exclusion criteria to ensure patient safety and the accuracy of study results
Common reasons patients may not be able to join cancer studies include having certain other medical conditions, taking medications that could interfere with the study treatment, or having abnormal blood test results
For this specific trial, you would need to discuss directly with the study doctors to learn the complete list of reasons that would prevent participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Odense University Hospital	Odense	Denmark
Hospital Clinic De Barcelona	Barcelona	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hqkskciq Vnxu ddyplpet	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	25.09.2025
Denmark	Recruiting	25.09.2025
France	Recruiting	25.09.2025
Germany	Recruiting	25.09.2025
Italy	Recruiting	25.09.2025
Spain	Recruiting	25.09.2025

Trial locations

Investigated drugs:

ECI830 is an investigational medication being studied in this trial. It is being tested both on its own and in combination with other treatments to see how well it works and how safe it is for patients with advanced breast cancer and other advanced solid tumors.

Ribociclib is a medication that works by blocking certain proteins called CDK4 and CDK6, which help cancer cells grow and divide. By blocking these proteins, ribociclib can help slow or stop the growth of cancer cells. In this trial, it is being used in combination with other medications.

Fulvestrant is a hormone therapy medication used to treat certain types of breast cancer that grow in response to the hormone estrogen. It works by blocking and breaking down estrogen receptors in cancer cells, which helps stop the cancer from growing. In this trial, it is being used together with other medications.

Investigated diseases:

Advanced Solid Tumors – This condition refers to cancerous growths that have progressed beyond their original site in the body. Solid tumors are abnormal masses of tissue that develop in organs or tissues throughout the body, unlike blood cancers. When classified as advanced, these tumors have typically grown larger in size or spread to nearby tissues. The cancer cells may have also traveled to other parts of the body through the bloodstream or lymphatic system. As the disease progresses, the tumors continue to grow and may affect the function of surrounding organs. The advancement of solid tumors represents a later stage in the disease course where the cancer has become more widespread.

Advanced Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer – This is a specific type of breast cancer that has progressed beyond its early stages and spread within the breast or to other parts of the body. The cancer cells have receptors for hormones like estrogen or progesterone, which means hormones can fuel their growth. These cancer cells do not have excessive amounts of a protein called HER2 on their surface. As the disease advances, the cancer may spread to lymph nodes near the breast or to distant organs. The progression typically occurs when cancer cells break away from the original tumor and travel through the body. This form of breast cancer continues to grow and spread despite initial treatment efforts.

Trial ID:

2024-517281-42-00

Protocol code:

CECI830A12101

NCT ID:

NCT06726148

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of ECI830, ribociclib, and fulvestrant in patients with advanced hormone receptor positive, HER2-negative breast cancer and advanced solid tumors

What is this study about?

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