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Study of ECI830 for Advanced Breast Cancer and Other Solid Tumors

This study is testing a new experimental drug called ECI830, either by itself or combined with approved medications, ribociclib and fulvestrant. It's for adults aged 18 to 100 with advanced hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer that has progressed after other treatments, or other advanced solid tumors. The study aims to find a safe dose of ECI830 and see how well it works against these cancers. For the first part of the study (Phase I), researchers will look at side effects and how well patients tolerate the drug. In the second part (Phase II), they will focus on how effective the combination treatment is for advanced breast cancer. The study is currently unclear on its recruitment status.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is planned to include 280 participants and has both a Phase I (safety and dosing) and a Phase II (effectiveness) part.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For the Phase I part of the study, researchers will track side effects and dose adjustments for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06726148

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~280 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:ECI830ribociclibfulvestrant

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Incidence of dose-limiting toxicities (DLTs)
Measured over 2 years
+3 more outcomes measured

Conditions

Advanced HR+/HER2- Breast Cancer
Advanced CCNE1-amplified Solid Tumors
Extensive-stage Small Cell Lung Cancer

Explore related trials

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Where it's being run

33 sites across 27 states
Victoria2
Denmark2
France2
Germany2
Israel2
Spain2
California1
Florida1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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What this trial measures

  • Phase I: Incidence of dose-limiting toxicities (DLTs)2 years

    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.

  • Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)2 years

    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.

  • Phase I: Number of participants with dose interruptions, reductions and discontinuations2 years

    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.

  • Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.16 months

    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.