Study on ECI830 Alone or with Other Drugs for Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT06726148
This clinical trial is testing a new drug, ECI830, alone and in combination with other medications, to see if it is safe and effective for treating advanced HR+/HER2- breast cancer and other advanced solid tumors.
Patient Parameters
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Program Overview
The study is divided into two phases. Phase I focuses on understanding the safety and appropriate dosage of ECI830, both on its own and when combined with ribociclib and fulvestrant. Phase II aims to evaluate how well ECI830 works in combination with these drugs to fight tumors in patients with advanced hormone receptor-positive, HER2-negative breast cancer.
Description
This is a first-time study involving humans, conducted across multiple centers. It includes two parts: one where ECI830 is given alone to patients with advanced HR+/HER2- breast cancer or other solid tumors with a specific genetic feature (CCNE1 amplification), and another where ECI830 is combined with ribociclib and fulvestrant for advanced breast cancer patients. The study will start by testing different doses to find the best one, and may expand to include more patients based on their specific type of cancer. The combination treatment may continue into a larger Phase II study to further explore its effectiveness in advanced breast cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- For Phase I: Patients with advanced HR+/HER2- breast cancer that has worsened after at least one hormone-based therapy combined with a CDK4/6 inhibitor and one other systemic treatment for metastatic cancer.
- Patients with advanced or metastatic cancer confirmed by lab tests, showing a specific genetic feature (CCNE1 amplification). For dose expansion, no more than 3 previous treatments for advanced cancer.
- For Phase II: Patients with advanced HR+/HER2- breast cancer that has worsened after treatment with an aromatase inhibitor or tamoxifen combined with a CDK4/6 inhibitor, with no more than 2 lines of hormone therapy.
- Must have measurable disease as per standard criteria. For breast cancer, if no measurable disease, at least one bone lesion must be present for assessment.
Exclusion Criteria
- Previous treatment with a CDK2 inhibitor.
- Poor bone marrow or organ function with abnormal lab results.
- Uncontrolled heart disease or heart rhythm problems, including recent heart attack or surgery, long QT syndrome, or risk factors for a specific heart rhythm disorder.
- Symptomatic brain metastases or those needing local treatment or increased steroid doses within 2 weeks before the study.
- For combination treatment: Patients with severe organ disease or disease burden unsuitable for hormone therapy.
- Patients who couldn't tolerate ribociclib in the past due to side effects.
- Breast cancer patients using hormone replacement therapy.
- Women of childbearing potential not using effective birth control, or who are pregnant or breastfeeding.
- Other specific criteria as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California LA | 90095 | Los Angeles | California |
| Florida Cancer Specialists | 33901 | Fort Myers | Florida |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| WA Uni School Of Med | 63110 | St Louis | Missouri |
| Memorial Sloan Kettering | 10017 | New York | New York |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| MD Anderson Cancer Center Uni of Te | 77030 | Houston | Texas |
| Fred Hutch Cancer Research | 98109 | Seattle | Washington |
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