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
2 other identifiers
interventional
280
16 countries
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Typical duration for phase_1
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2024
CompletedFirst Posted
Study publicly available on registry
December 10, 2024
CompletedStudy Start
First participant enrolled
April 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 25, 2028
April 27, 2026
April 1, 2026
3.5 years
December 5, 2024
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase I: Incidence of dose-limiting toxicities (DLTs)
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
2 years
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
2 years
Phase I: Number of participants with dose interruptions, reductions and discontinuations
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow patients to continue the study treatment.
2 years
Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
Progression Free Survival (PFS) rate at 6 months is defined as the proportion of patients who are alive and progression-free per RECIST v1.1 at 6 months.
6 months
Secondary Outcomes (11)
Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Phase I and II: Best overall response (BOR) per RECIST v1.1
2 years
Phase I and II: Overall response rate (ORR) per RECIST v1.1
2 years
Phase I and II: Disease control rate (DCR) per RECIST v1.1
2 years
- +6 more secondary outcomes
Study Arms (6)
ECI830 Single Agent (Arm A)
EXPERIMENTALPhase I
Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B)
EXPERIMENTALPhase I
Ribociclib in combination with fulvestrant (Arm C)
EXPERIMENTALPhase II
ECI830 in combination with fulvestrant (Arm D)
EXPERIMENTALPhase II
ECI830 in combination with ribociclib and fulvestrant (Arm E)
EXPERIMENTALPhase II
ECI830 in combination with ribociclib and fulvestrant (Arm F)
EXPERIMENTALPhase II
Interventions
Experimental
Approved medication
Approved medication
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Previous treatment with a CDK2 inhibitor at any time.
- 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.
- Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
- For the combination treatment:
- Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
- 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.
- WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of California LA
Los Angeles, California, 90095, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
WA Uni School Of Med
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering
New York, New York, 10017, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center Uni of Te
Houston, Texas, 77030, United States
Fred Hutch Cancer Research
Seattle, Washington, 98109, United States
Novartis Investigative Site
Clayton, Victoria, 3168, Australia
Novartis Investigative Site
Melbourne, Victoria, 3004, Australia
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
Montreal, Quebec, H4A 3J1, Canada
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Xian, Shanxi, 710061, China
Novartis Investigative Site
Brno, 656 53, Czechia
Novartis Investigative Site
Copenhagen, DK-2100, Denmark
Novartis Investigative Site
Odense C, 5000, Denmark
Novartis Investigative Site
Bordeaux, 33076, France
Novartis Investigative Site
Saint-Herblain, 44805, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Haifa, 3109601, Israel
Novartis Investigative Site
Tel Aviv, 6423906, Israel
Novartis Investigative Site
Modena, MO, 41124, Italy
Novartis Investigative Site
Milan, 20141, Italy
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045, Japan
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Barcelona, 08035, Spain
Novartis Investigative Site
Barcelona, 08036, Spain
Novartis Investigative Site
Tainan, 704, Taiwan
Novartis Investigative Site
London, Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 5, 2024
First Posted
December 10, 2024
Study Start
April 3, 2025
Primary Completion (Estimated)
September 25, 2028
Study Completion (Estimated)
September 25, 2028
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.