Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06726148 | Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors | PHASE1 | RECRUITING | 280 | — | — | Apr 3, 2025 | Sep 25, 2028 | Apr 27, 2026 | 33 | United States, Australia +14 |
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...