In short
ECI830 is an investigational oral cancer medicine being studied in patients with advanced solid tumors, including advanced HR+/HER2- breast cancer. One registered clinical trial is currently authorised, a Phase 1/2 study with a planned enrollment of 121 participants. The trial evaluates ECI830 alone and in combination with ribociclib and fulvestrant, focusing first on safety and then on anti-tumor activity.
Key points
- ECI830 is an investigational oral therapy for advanced solid tumors.
- The registered trial is a Phase 1/2 study with a planned enrollment of 121 participants.
- The study includes patients with advanced HR+/HER2- breast cancer and other advanced solid tumors.
- Phase I measures safety and tolerability, including dose-limiting toxicities and adverse events.
- Phase II measures progression-free survival (PFS) rate at 6 months using RECIST v1.1 criteria.
- ECI830 is given orally, also in combination with ribociclib and fulvestrant.
What is ECI830?
ECI830 is an investigational substance that is being developed as a potential cancer therapy. The registry records describe it as a drug given by mouth (oral route). It is not yet authorised as a medicine; the available data come from a single registered clinical trial in which ECI830 is the test substance. The full name used in the trial record is ECI830, and no other names or development codes are given in the data.
How does ECI830 work?
The registry data provided do not include a description of the molecular target or mechanism of action of ECI830. The trial record states that ECI830 is being assessed as a single agent and in combination with ribociclib and fulvestrant, but it does not explain how ECI830 acts on cancer cells. No supplementary sources are available in the data to describe the mechanism of action.
Which conditions is ECI830 studied for?
- Advanced HR+/HER2- breast cancer — a form of breast cancer that is hormone receptor-positive and does not overexpress the HER2 protein, which has progressed despite prior treatment.
- Advanced solid tumors — cancers that form solid masses and have spread or cannot be removed by surgery.
How is ECI830 given?
In the registered trial, ECI830 is given by mouth (oral route). The trial also uses other drugs as combination partners or comparison treatments: ribociclib is given orally, fulvestrant is given as an intramuscular injection, and leuprorelin acetate and goserelin are given as subcutaneous injections. The data do not specify the pharmaceutical form of ECI830 beyond the oral route.
What do the clinical trials show?
One registered clinical trial of ECI830 is currently authorised: a Phase 1/2 interventional study with a planned enrollment of 121 participants. The study is not yet recruiting, and no results have been reported in the registry.
What are the trials measuring?
Phase I of the trial measures safety and tolerability. The primary outcomes are the incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs and electrocardiograms (ECGs). Tolerability is assessed by the frequency of dose interruptions, dose reductions and treatment discontinuations.
Phase II measures anti-tumor activity using progression-free survival (PFS) rate at 6 months, evaluated per local response evaluation criteria in solid tumors (RECIST v1.1). Progression-free survival is the length of time a patient lives without the cancer getting worse.
Who can take part in these trials?
The trial enrolls patients with advanced HR+/HER2- breast cancer who have progressed on first-line CDK4/6 inhibitor therapy, as well as patients with other advanced solid tumors. Detailed eligibility criteria are listed in the trial registry record.
What side effects are known?
The registry data provided do not include a list of known side effects for ECI830. The Phase I part of the trial is designed to identify dose-limiting toxicities, adverse events and serious adverse events, but no results have been reported yet.