Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ECI830 · 1 trial · 3 indications
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| ECI830 Single Agent (Arm A) | EXPERIMENTAL | Phase I |
| Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) | EXPERIMENTAL | Phase I |
| Ribociclib in combination with fulvestrant (Arm C) | EXPERIMENTAL | Phase II |
| ECI830 in combination with fulvestrant (Arm D) | EXPERIMENTAL | Phase II |
| ECI830 in combination with ribociclib and fulvestrant (Arm E) | EXPERIMENTAL | Phase II |
| ECI830 in combination with ribociclib and fulvestrant (Arm F) | EXPERIMENTAL | Phase II |
| Name | Type | Description |
|---|---|---|
| ECI830 | DRUG | Experimental |
| ribociclib | DRUG | Approved medication |
| fulvestrant | DRUG | Approved medication |
Inclusion Criteria: 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 dis...
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ECI830 is an investigational small molecule being studied for the treatment of advanced HR+/HER2- breast cancer. It is also being evaluated in patients with advanced CCNE1-amplified solid tumors and extensive-stage small cell lung cancer. The drug is currently in Phase 1 clinical development.
ECI830 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials for advanced HR+/HER2- breast cancer and other advanced solid tumors.
ECI830 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate the safety and efficacy of ECI830 as a single agent or in combination therapy.
ECI830 is being studied in a Phase 1 clinical trial with the identifier NCT06726148. This trial is recruiting 280 participants and is evaluating ECI830 as a single agent or in combination for patients with advanced HR+/HER2- breast cancer, advanced CCNE1-amplified solid tumors, and extensive-stage small cell lung cancer.
Yes, the Phase 1 clinical trial of ECI830 is randomized and controlled. The study is not double-blinded, but it does include a control group. The trial is actively recruiting participants across multiple countries, including the United States, Australia, Canada, China, and several European and Asian nations.