OncoMatch/Clinical Trials/NCT06726148
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Is NCT06726148 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including ECI830 and ribociclib for advanced hr+/her2- breast cancer.
Treatment: ECI830 · ribociclib · fulvestrant — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Tumor Agnostic
Small Cell Lung Cancer
Biomarker criteria
Required: CCNE1 amplification
locally advanced or metastatic cancer with a CCNE1 amplification
Disease stage
Required: Stage III, IV
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.
Demographics
Prior therapy
Must have received: hormonal therapy in combination with CDK4/6 inhibitor — HR+/HER2- advanced breast cancer
disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i
Must have received: systemic therapy — HR+/HER2- advanced breast cancer
at least one additional line of systemic therapy for metastatic disease
Must have received: aromatase inhibitor or tamoxifen in combination with CDK4/6 inhibitor — unresectable/metastatic HR+/HER2- breast cancer
disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease
Must have received: standard of care — extensive-stage small cell lung cancer
ES-SCLC and disease progression on or after standard of care (SoC)
Cannot have received: CDK2 inhibitor
Previous treatment with a CDK2 inhibitor at any time
Lab requirements
Blood counts
Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values [excluded]
Kidney function
Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values [excluded]
Liver function
Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values [excluded]
Cardiac function
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP [excluded]
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California LA · Los Angeles, California
- Florida Cancer Specialists · Fort Myers, Florida
- Dana Farber Cancer Institute · Boston, Massachusetts
- WA Uni School Of Med · St Louis, Missouri
- Memorial Sloan Kettering · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06726148 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK2 inhibitor disqualifies patients from enrollment.
Does this trial require CCNE1?
Yes, CCNE1 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages