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OncoMatch/Clinical Trials/NCT06726148

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

Is NCT06726148 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including ECI830 and ribociclib for advanced hr+/her2- breast cancer.

Phase 1/2RecruitingNovartis PharmaceuticalsNCT06726148Data as of Jun 2026Location: International · 14 countries

Treatment: ECI830 · ribociclib · fulvestrantPhase 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

ribociclib

Endocrine / hormonal

fulvestrant

Other

ECI830

Cancer type

Breast Carcinoma

Tumor Agnostic

Biomarker criteria

Required: CCNE1 amplification

Required: HER2 (ERBB2) wild-type

Disease stage

Required: Stage III, IV

Metastatic disease required

locally advanced or metastatic cancer; unresectable/metastatic disease

Demographics

Ages ≤ 100

Prior therapy

Min 1 prior line

Must have received: hormonal therapy — metastatic

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

Must have received: CDK4/6 inhibitor — metastatic

disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i

Cannot have received: CDK2 inhibitor

Previous treatment with a CDK2 inhibitor at any time

Lab requirements

Blood counts

no inadequate bone marrow function with out-of-range laboratory values

Kidney function

no inadequate organ function with out-of-range laboratory values

Liver function

no inadequate organ function with out-of-range laboratory values

Cardiac function

no clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP

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.

Does this trial require ERBB2?

Yes, ERBB2 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required (metastatic disease 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.

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