C4891026 - AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER

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: -AEs as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), seriousness, and relationship to vepdegestrant in combination with PF-07220060; -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 vepdegestrant, ARV-473, and PF-07220060. -Steady-state Cmax, Tmax, and AUClast of vepdegestrant, ARV-473, and PF-07220060. -If data permit CL/F, Vz/F, and t½ of vepdegestrant, ARV-473, and PF- 07220060., 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: -AEs as characterized by type, frequency, intensity (as graded by NCI CTCAE version 5.0), seriousness, and relationship to vepdegestrant in combination with PF-07220060. -Incidence of laboratory abnormalities. -Incidence of ECG abnormalities, Phase 2: Plasma concentrations of vepdegestrant, ARV-473, and PF-07220060., Phase 2: ctDNA plasma quantitative changes from pre-treatment to evaluate potential predictability of their associations with clinical outcomes.

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