C4891006 - 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 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY A (ARV-471 IN COMBINATION WITH ABEMACICLIB)

ER +/HER2- 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.

Phase 1b ad 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 abemaciclib. •Laboratory test abnormalities as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), and timing., 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 2: DoR by investigator assessment. • CBR (confirmed CR or PR at any time, or SD ≥24 weeks) byinvestigator assessment. • PFS by investigator assessment • OS., Phase 1b and Phase 2: Plasma concentrations of ARV-471, ARV-473, abemaciclib, and abemaciclib active metabolites M2, M18 and M20., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes., Phase 1b: AUCtau and Cmax of abemaciclib, M2, M18 and M20, with and without coadministration of ARV 471.

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