RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

This research study is investigating a new medication called ECI830. We want to understand how safe it is and how well it's tolerated by people with advanced breast cancer (specifically, the HR+/HER2- type) and other solid tumors that have a specific genetic change (CCNE1 amplification). Doctors are testing ECI830 by itself and also in combination with two existing cancer drugs: ribociclib and fulvestrant. The first part of the study focuses on finding the right dose for ECI830. The second part will then look at how effective this combination treatment is in treating advanced breast cancer. It's hoped that ECI830 could offer a new treatment option for these cancers.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

280

Start

03 Apr 2025

Estimated completion

25 Sep 2028

Advanced HR+/HER2- Breast Cancer Advanced CCNE1-amplified Solid Tumors

What is this study about?

This study is testing a new experimental medicine called ECI830. Doctors want to see if it can be a helpful new treatment for certain types of advanced cancer. Specifically, they are focusing on advanced breast cancer that is hormone receptor-positive Helper (HR+) and HER2-negative (HER2-), and also other advanced solid tumors that have a particular genetic feature called CCNE1 amplification. These are cancers that have spread and can be difficult to treat.

The study has two main parts. The first part (called Phase 1) is all about safety. Researchers will give ECI830 to a small group of patients, either on its own or in combination with two other established cancer drugs, ribociclib and fulvestrant. Their main goal is to understand any side effects and to figure out the safest and most effective dose for ECI830.

Once a safe dose is found, the study moves to the second part (Phase 2). Here, more patients with advanced HR+/HER2- breast cancer will receive ECI830 along with ribociclib and fulvestrant. The main aim of this phase is to see how well this combination treatment works to shrink tumors or stop them from growing. The hope is that ECI830 could become a valuable new option in treating these specific advanced cancers.

Key takeaways

Tests a new medicine, ECI830, for advanced cancers.
Focuses on advanced HR+/HER2- breast cancer and CCNE1-amplified solid tumors.
Aims to find a safe dose and check if the treatment works.
Involves ECI830 alone or with existing drugs ribociclib and fulvestrant.
Requires regular hospital visits, tests, and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old.

For the first part of the study (Phase 1), you might be eligible if you have advanced HR+/HER2- breast cancer that has continued to grow after previous hormone-based and other treatments. Or, you could be eligible if you have another type of advanced solid tumor with a specific genetic change called CCNE1 amplification. For this specific genetic type, you should not have had more than three previous treatments for your advanced cancer.

For the second part of the study (Phase 2), you could join if you have advanced HR+/HER2- breast cancer that has worsened after treatment with an aromatase inhibitor or tamoxifen combined with a CDK4/6 inhibitor, and you haven't received more than two previous hormone treatments. For all participants, your cancer must be measurable, either by scans or by a specific bone lesion if it's breast cancer. You would not be able to join if you've already had a similar drug to ECI830 (a CDK2 inhibitor), have uncontrolled heart conditions, serious issues with your blood or organs, or certain brain metastases. If you're a woman who could become pregnant, you must agree to use highly effective birth control.

Quick self-check

Are you 18 years old or older?
Do you have advanced HR+/HER2- breast cancer or a CCNE1-amplified solid tumor?
Has your cancer progressed on previous treatments?
Do you have measurable cancer (seen on scans or specific bone lesions)?
Have you not had a similar drug to ECI830 (a CDK2 inhibitor) previously?
Do you not have uncontrolled heart problems or serious blood/organ issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive the study medication (ECI830, either on its own or with ribociclib and fulvestrant) at a study clinic. You'll have regular hospital visits for blood tests, physical examinations, and scans to check how you're doing and how the treatment is affecting your cancer. These tests help the doctors monitor your health and the progress of the treatment.

Throughout the study, the medical team will closely watch for any side effects and manage them. You will continue treatment for as long as it is helping you and you are tolerating it well. The total duration of your participation will depend on how you respond to the treatment, but visits and assessments will be scheduled regularly to ensure your safety and monitor the effectiveness of the drug.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to try a new medicine that isn't yet widely available, which could potentially help your condition. However, like all medicines, ECI830 may have side effects, some of which could be serious or currently unknown. You may have to attend more hospital appointments than usual for tests and check-ups. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

University of California LA
Los Angeles, United States· Recruiting
Florida Cancer Specialists
Fort Myers, United States· Recruiting
Dana Farber Cancer Institute
Boston, United States· Recruiting
WA Uni School Of Med
St Louis, United States· Recruiting
Memorial Sloan Kettering
New York, United States· Recruiting
SCRI Oncology Partners
Nashville, United States· Recruiting
MD Anderson Cancer Center Uni of Te
Houston, United States· Recruiting
Fred Hutch Cancer Research
Seattle, United States· Recruiting
Novartis Investigative Site
Clayton, Australia· Recruiting
Novartis Investigative Site
Melbourne, Australia· Recruiting
Novartis Investigative Site
Toronto, Canada· Recruiting
Novartis Investigative Site
Montreal, Canada· Recruiting

+21 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

This study is for advanced HR+/HER2- breast cancer and other advanced solid tumors that have a specific genetic change called CCNE1 amplification.

What are the main goals of the study?

The main goals are to find a safe dose for the new drug ECI830 and to see how well it works to treat these specific cancers.

Will I take ECI830 alone or with other drugs?

Depending on the part of the study and your specific cancer, you might take ECI830 by itself or in combination with ribociclib and fulvestrant.

How long would I be in the study?

You would stay in the study for as long as the treatment is helping you and you are tolerating it without major side effects.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, and this will not affect your future medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.