C4891024 - TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Advanced or Metastatic Breast Cancer

Phase 1b: DLTs during DLT observation period (Cycle 1)., Phase 2: Confirmed OR (CR or PR) determined by investigator assessment., DDI Assessment Cohort(s): Steady-state AUCtau and Cmax of ARV-471 with and without coadministration of samuraciclib, Single dose AUC0-72 and Cmax of samuraciclib with and without coadministration of ARV-471.

Phase 1b: • Incidence of AEs and SAEs. • Incidence of laboratory abnormalities. • Incidence of ECG abnormalities, Phase 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 1b: Plasma concentrations of ARV-471, ARV-473, and samuraciclib., 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 2: • Incidence of AEs and SAEs. • Incidence of laboratory abnormalities. • Incidence of ECG abnormalities., Phase 2: Plasma concentrations of ARV-471, ARV-473 and samuraciclib., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes., Phase 2: TP53 status defined from analysis of baseline ctDNA., DDI Assessment Cohort(s): Incidence of AEs and SAEs, Incidence of laboratory abnormalities, Incidence of ECG abnormalities.

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