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Taking people in ChinaPhase 1/2

Testing ECI830 alone or with other drugs for advanced cancers

Tests the drug ECI830 in adults with advanced breast cancer or other solid tumors.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Nanjing and Xian, ChinaSee the 2 sitesAlso in 15 other countries, 33 sites
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
Status
Recruiting
Phase
Phase 1/2
People taking part
280 people, planned
Started
3 Apr 2025
Expected to end
25 Sept 2028
Type of study
Interventional, 6 groups
Treatments tested
  • ECI830
  • ribociclib
  • fulvestrant
Record updated
27 August 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in China

Also in 15 other countries, 33 sites

  • Nanjing, JiangsuHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Xian, ShanxiHospital not named in the registryContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

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

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.

The 6 groups in the trial

  • ECI830 Single Agent (Arm A)Treatment being tested

    Phase I

    Treatment: ECI830

  • Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B)Treatment being tested

    Phase I

    Treatment: ECI830, ribociclib, and fulvestrant

  • Ribociclib in combination with fulvestrant (Arm C)Treatment being tested

    Phase II

    Treatment: ribociclib and fulvestrant

  • ECI830 in combination with fulvestrant (Arm D)Treatment being tested

    Phase II

    Treatment: ECI830 and fulvestrant

  • ECI830 in combination with ribociclib and fulvestrant (Arm E)Treatment being tested

    Phase II

    Treatment: ECI830, ribociclib, and fulvestrant

  • ECI830 in combination with ribociclib and fulvestrant (Arm F)Treatment being tested

    Phase II

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing ECI830 alone or with other drugs for advanced cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06726148, who can take part
Record updated
27 August 2026