Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
NCT ID: NCT06726148
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
280 participants
INTERVENTIONAL
2025-04-03
2028-09-25
Brief Summary
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Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ECI830 Single Agent (Arm A)
Phase I
ECI830
Experimental
Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B)
Phase I
ECI830
Experimental
ribociclib
Approved medication
fulvestrant
Approved medication
Ribociclib in combination with fulvestrant (Arm C)
Phase II
ribociclib
Approved medication
fulvestrant
Approved medication
ECI830 in combination with fulvestrant (Arm D)
Phase II
ECI830
Experimental
fulvestrant
Approved medication
ECI830 in combination with ribociclib and fulvestrant (Arm E)
Phase II
ECI830
Experimental
ribociclib
Approved medication
fulvestrant
Approved medication
ECI830 in combination with ribociclib and fulvestrant (Arm F)
Phase II
ECI830
Experimental
ribociclib
Approved medication
fulvestrant
Approved medication
Interventions
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ECI830
Experimental
ribociclib
Approved medication
fulvestrant
Approved medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients with one of the following indications:
Phase I:
HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
Phase II:
HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.
Measurable disease as determined by RECIST v1.1.
BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
Exclusion Criteria
Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.
Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
For the combination treatment:
Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
Patients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.
For patients with BC: Patient is concurrently using hormone replacement therapy.
WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of California LA
Los Angeles, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
WA Uni School Of Med
St Louis, Missouri, United States
Memorial Sloan Kettering
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center Uni of Te
Houston, Texas, United States
Fred Hutch Cancer Research
Seattle, Washington, United States
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Odense C, , Denmark
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Tainan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Dashika Wijegooneratne
Role: primary
Marissa Lisle
Role: primary
Marco Reyes
Role: primary
Tracy Summa
Role: primary
Sam Stefanik
Role: primary
Megan Michela
Role: primary
Benjamin Batista Ramos
Role: primary
Hannah Lee
Role: primary
Other Identifiers
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2024-517281-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
CECI830A12101
Identifier Type: -
Identifier Source: org_study_id