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

NCT06726148 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

ECI830

Experimental

DRUG

ribociclib

Approved medication

DRUG

fulvestrant

Approved medication

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2028-09-25
Completion
2028-09-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726148 on ClinicalTrials.gov