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...
Top 20 of 87 competitors
ECI830 is an investigational small molecule developed by Novartis AG for advanced HR+/HER2- breast cancer and other advanced solid tumors. It is being studied as a single agent and in combination with other therapies. ECI830 is in Phase 1 clinical development and has not been approved by the FDA.
ECI830 is being evaluated for the treatment of advanced HR+/HER2- breast cancer, meaning hormone receptor positive and HER2 negative disease. The Phase 1 study also enrolls patients with advanced CCNE1-amplified solid tumors and extensive-stage small cell lung cancer. ECI830 remains investigational and is not approved for any indication.
ECI830 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the Phase 1 clinical program evaluating ECI830 in advanced HR+/HER2- breast cancer and other advanced solid tumors.
ECI830 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The Phase 1 program is currently recruiting participants and is designed to evaluate ECI830 as a single agent and in combination in patients with advanced solid tumors.
ECI830 is being studied in the Phase 1 trial NCT06726148, titled Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors. The trial is recruiting, is controlled and randomized, and plans to enroll 280 participants across 16 countries.
The NCT06726148 trial enrolls adults aged 18 years and older of any sex. It includes patients with advanced HR+/HER2- breast cancer, advanced CCNE1-amplified solid tumors, and extensive-stage small cell lung cancer. Healthy volunteers are not eligible, and enrollment is biomarker selected for the relevant tumor types.