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

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

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-100

SponsorNovartis Pharmaceuticals

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

ECI830
ribociclib
fulvestrant

Treatment groups

280 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Locations

Australia

Novartis Investigative Site3168, ClaytonVictoria, Australia

Novartis Investigative Site3004, MelbourneVictoria, Australia

Canada

Novartis Investigative SiteM5G 2M9, TorontoOntario, Canada

Novartis Investigative SiteH4A 3J1, MontrealQuebec, Canada

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov