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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT06726148

Registry updated: 2026-08-27
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Description

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.

Interventions

  • ECI830 (Drug)
    Experimental
  • ribociclib (Drug)
    Approved medication
  • fulvestrant (Drug)
    Approved medication

Eligibility 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. Patients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed. 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.

Conditions

Advanced HR+/HER2- Breast Cancer Advanced CCNE1-amplified Solid Tumors Extensive-stage Small Cell Lung Cancer

Locations

  • 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 — Montreal, Quebec, Canada
  • Novartis Investigative Site — Nanjing, Jiangsu, China
  • Novartis Investigative Site — Xian, Shanxi, China
  • Novartis Investigative Site — Brno, Czechia
  • Novartis Investigative Site — Copenhagen, Denmark
  • Novartis Investigative Site — Odense C, Denmark
  • Novartis Investigative Site — Bordeaux, France
  • Novartis Investigative Site — Saint-Herblain, France
  • Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Novartis Investigative Site — Heidelberg, Germany
  • Novartis Investigative Site — Ulm, Germany
  • Novartis Investigative Site — Haifa, Israel
  • Novartis Investigative Site — Tel Aviv, Israel
  • Novartis Investigative Site — Milan, MI, Italy
  • Novartis Investigative Site — Modena, MO, Italy
  • Novartis Investigative Site — Chuo Ku, Tokyo, Japan
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Seoul, Seoul, South Korea
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Tainan, Taiwan
  • Novartis Investigative Site — London, Oxford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record