Testing ECI830 alone or with other drugs for advanced cancers
Tests the drug ECI830 in adults with advanced breast cancer or other solid tumors.
Plain-language title generated from the registry record
Registry title: Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Key facts
- Where
- Brno-Stred, CzechiaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced HR+/HER2- breast cancer, advanced solid tumors with a CCNE1 amplification, or extensive-stage small cell lung cancer, whose disease has progressed after earlier treatment.
- Age
- 18 years or older (up to 100 years)
- Sex
- All sexes can join
- Disease stage
- Locally advanced or metastatic cancer. Phase I: HR+/HER2- advanced breast cancer, solid tumors with CCNE1 amplification, or extensive-stage small cell lung cancer. Phase II: HR+/HER2- advanced breast cancer. Measurable disease by RECIST v1.1 is needed in Phase II; in breast cancer, a mainly lytic bone lesion can replace it.
- Earlier treatment
- Breast cancer, Phase I: disease progressed after hormone-based therapy with a CDK4/6 inhibitor and at least one more systemic therapy for metastatic disease. Phase II: progressed on an aromatase inhibitor or tamoxifen with a CDK4/6 inhibitor, with no more than 2 lines of endocrine therapy. Small cell lung cancer: progressed on or after standard of care. Expansion part: no more than 3 prior lines (CCNE1) or 2 prior lines (small cell lung cancer). Earlier CDK2 inhibitor treatment is not allowed.
- Biomarker or test result
- CCNE1 amplification for the solid tumor group. HR+/HER2- status for the breast cancer groups.
Main reasons for not taking part
- Previous treatment with a CDK2 inhibitor
- Poor bone marrow or organ function on lab tests
- Serious uncontrolled heart disease or heart rhythm problems
- Symptomatic brain metastases, or ones needing local therapy or more steroids within 2 weeks before the start
- Pregnant or nursing women, or women who can have children and will not use highly effective contraception
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06726148, who can take part
Where in Czechia
- Masarykuv Onkologicky UstavBrno-Stred, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06726148EU 2024-517281-42-00
- Record updated
- 27 August 2026
- Original 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.Read full original descriptionShow less
An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
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: 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: Previous treatment with a CDK2 inhibitor at any time; Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry; 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; Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy; 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; For the combination treatment:; WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women; Other protocol-defined inclusion/exclusion criteria may apply.