RecruitingPhase 1Phase 2NCT06726148

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

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

Sponsor

Novartis Pharmaceuticals

Enrollment

280 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced HR+/HER2- Breast Cancer Advanced CCNE1-amplified Solid Tumors

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests ECI830, a new experimental drug, alone or in combination with other treatments, in patients with advanced hormone receptor-positive, HER2-negative breast cancer and other solid tumors that have progressed despite prior therapies. **You may be eligible if...** - Age 18 or older - Have hormone receptor-positive (HR+), HER2-negative advanced breast cancer that has progressed after at least one hormone-based therapy plus a CDK4/6 inhibitor, and at least one additional therapy - Or have another advanced solid tumor type specified in the protocol - Have adequate organ function **You may NOT be eligible if...** - Have untreated brain metastases (cancer spread to the brain) - Have received an excessive number of prior treatment lines - Have serious heart, liver, or other organ problems - Are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGECI830

Experimental

DRUGribociclib

Approved medication

DRUGfulvestrant

Approved medication

Locations(33)

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

Modena, MO, Italy

Novartis Investigative Site

Milan, Italy

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

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

View Full Details on ClinicalTrials.gov

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NCT06726148

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