ER+/HER2- Advanced or Metastatic Breast Cancer
Conditions
Brief summary
Phase 1b: DLTs during DLT observation period (Cycle 1)., Fase 2: Confirmed OR (CR or PR) determined by investigator assessment., DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ribociclib with and without co-administration of ARV-471.
Detailed description
Phase 1b and Phase 2: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to ARV-471 in combination with ribociclib. •Laboratory test abnormalities as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), and timing., Fase 1b: Confirmed OR (CR or PR) by investigator assessment. · DoR by investigator assessment. · CBR (confirmed CR or PR at any time, or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. Phase 2: DoR by investigator assessment. · CBR (confirmed CR or PR at any time or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. · OS., Phase 1b and Phase 2: Plasma concentrations of ARV-471, ARV-473, and ribociclib., Phase 1b: AUCtau and Cmax of ARV-471 with and without co-administration of ribociclib., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes., DDI Assessment Cohort(s): - Incidence of AEs and SAEs. - Incidence of laboratory abnormalities. - Incidence of ECG abnormalities.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b: DLTs during DLT observation period (Cycle 1)., Fase 2: Confirmed OR (CR or PR) determined by investigator assessment., DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ribociclib with and without co-administration of ARV-471. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1b and Phase 2: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to ARV-471 in combination with ribociclib. •Laboratory test abnormalities as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), and timing., Fase 1b: Confirmed OR (CR or PR) by investigator assessment. · DoR by investigator assessment. · CBR (confirmed CR or PR at any time, or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. Phase 2: DoR by investigator assessment. · CBR (confirmed CR or PR at any time or SD ≥24 weeks) by investigator assessment. · PFS by investigator assessment. · OS., Phase 1b and Phase 2: Plasma concentrations of ARV-471, ARV-473, and ribociclib., Phase 1b: AUCtau and Cmax of ARV-471 with and without co-administration of ribociclib., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinica | — |
Countries
Italy, Spain