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Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Trial Status: active
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in
combination with ribociclib and fulvestrant. Identify dose range for
optimization/recommended dose for future studies.
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.
Inclusion Criteria
Inclusion Criteria:
Age ≥ 18 years old.
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:
Previous treatment with a CDK2 inhibitor at any time.
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.
Other protocol-defined inclusion/exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06726148.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not Available
This is a first-in-human, open-label, phase I/II, multi-center study consisting of an
ECI830 single agent treatment arm in patients with advanced HR+/HER2- breast cancer or
other advanced solid tumors harboring CCNE1 amplification and a combination treatment arm
of ECI830 with ribociclib and fulvestrant in patients with advanced breast cancer. Single
agent escalation may be followed by an expansion part stratified by disease indication.
The escalation of the combination arm may continue into a randomized, open label, Phase
II with optional dose optimization in advanced breast cancer patients.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationNovartis Pharmaceuticals Corporation