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

Trial Details

NCT ID
NCT06726148
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • ECI830
  • ribociclib
  • fulvestrant
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Fort Myers, Florida, United States|26.62168,-81.84059
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Age ≥ 18 years old.
  • Patients with one of the following indications:
  • 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 ad…
  • Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion onl…

For full eligibility, visit ClinicalTrials.gov.

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