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.
None
None
Parallel
ECI830
DrugExperimental
ribociclib
DrugApproved medication
fulvestrant
DrugApproved medication
6
Treatment groupsSee each treatment group below.
Phase I: Incidence of dose-limiting toxicities (DLTs)
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.
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
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.
Phase I: Number of participants with dose interruptions, reductions and discontinuations
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.
Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
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.
Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
Pharmacokinetic (PK) parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
PK parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.
Phase I and II: Best overall response (BOR) per RECIST v1.1
BOR per RECIST v1.1 is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first.
Phase I and II: Overall response rate (ORR) per RECIST v1.1
ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR) according to RECIST v1.1 as per local review.
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